Title

Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis
A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Dose Regimens of CC-10004 in Subjects With Active Psoriatic Arthritis
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    apremilast ...
  • Study Participants

    204
This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.
Prior to the implementation of Amendment 1/UK3 the study consisted of 3 phases - pre-randomization up to 35 days, up to 84 days placebo-controlled treatment and a 28-day observational follow up. After the implementation of Amendment 1/UK3, the study consisted of 4 phases - pre-randomization up to 35 days, up to 84 days treatment in the placebo controlled treatment phase, up to 84 days treatment in the active treatment extension phase and a 28 day follow up. Participants who completed the treatment phase prior to implementation of amendment 1/UK3 did not have the option of entering the extension phase.
Study Started
Mar 05
2007
Primary Completion
May 09
2009
Study Completion
May 09
2009
Results Posted
Oct 23
2019
Last Update
Jun 19
2020

Drug Apremilast

Capsules for oral administration

  • Other names: CC-10004, Otezla®

Drug Placebo

Capsules for oral administration

Apremilast 40 mg QD Experimental

Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.

Apremilast 20 mg BID Experimental

Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.

Placebo Placebo Comparator

Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks.

Criteria

Inclusion Criteria:

Diagnosis of psoriatic arthritis (Moll and Wright Criteria), including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
Active psoriatic arthritis at the time of screening and baseline as defined by: 3 or more swollen joints AND 3 or more tender joints
Negative rheumatoid factor (RF)
If using methotrexate, be on methotrexate for at least 168 days (24 weeks) and be on a stable dose for at least 56 days prior to screening and throughout the study
If using oral corticosteroids, be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 28 days prior to screening and throughout the study
If using nonsteroidal anti-inflammatory drug (NSAID) therapy, be on a stable dose for at least 14 days prior to screening and throughout the study

Must meet the following laboratory criteria:

Hemoglobin ≥ 9 g/dL
Hematocrit ≥ 27%
White blood cell (WBC) count ≥ 3000/μL (≥ 3.0 X 10^9/L) and < 20,000/μL (< 20 X 10^9/L)
Neutrophils ≥ 1500 /μL (≥ 1.5 X 10^9/L)
Platelets ≥ 100,000 /μL (≥ 100 X 10^9/L)
Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
Total bilirubin ≤ 2.0 mg/dL
Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) ≤ 1.5x upper limit of normal (ULN)
Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO adequate forms of contraception while on study medication. A FCBP must agree to have pregnancy tests every 28 days while on study medication
Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for at least 84 days after taking the last dose of study medication

Exclusion Criteria:

History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases

Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Pregnant or lactating female
History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.
History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test [T SPOT®.TB, QuantiFERON Gold®])
Clinically significant abnormality on the chest x-ray (CXR) at screening
Current erythrodermic, guttate, or pustular forms of psoriasis
History of infected joint prosthesis within the past 5 years
Systemic therapy for psoriasis and/or psoriatic arthritis (except for methotrexate, ≤ 10 mg/day prednisone or equivalent, and NSAIDs) including, but not limited to, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids (including intra-articular), penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, and fumaric acid esters within 28 days of randomization and throughout the study
Topical therapy for the treatment of psoriasis including, but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin within 14 days of randomization (Note: Topical background therapy for treatment of psoriasis is allowed, except within 24 hours of a study visit, as follows: mild or moderate potency corticosteroids for treatment of the palms, face, scalp, axillae, plantar surfaces, and groin in accordance with the manufacturer's suggested usage. Nonmedicated emollients [eg, Eucerin®] and tar shampoo are also allowed.)
Phototherapy (ultraviolet light A [UVA], narrow-band ultraviolet light B [NB-UVB], psoralens and long-wave ultraviolet radiation [PUVA]) within 28 days prior to randomization
Etanercept use within 56 days prior to randomization
Adalimumab, efalizumab, or infliximab use within 84 days prior to randomization
Alefacept use within 168 days (24 weeks) prior to randomization
Use of intra-articular corticosteroids within 28 days prior to randomization
Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
Any clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
High-risk factor(s) for, or a history of, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection
History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
Evidence of skin conditions at the time of screening visit that would interfere with evaluations of the effect of study medication on psoriasis

Summary

Week 12: Apremilast 40 mg QD

Week 12: Apremilast 20 mg BID

Week 12: Placebo

Week 24: Apremilast 40 mg QD

Week 24: Apremilast 20 mg BID

All Events

Event Type Organ System Event Term Week 12: Apremilast 40 mg QD Week 12: Apremilast 20 mg BID Week 12: Placebo Week 24: Apremilast 40 mg QD Week 24: Apremilast 20 mg BID

Percentage of Participants With a Modified American College of Rheumatology 20% (ACR 20) Response at Week 12

A modified American College of Rheumatology 20% (ACR 20) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.

Apremilast 40 mg QD

35.8
percentage of participants

Apremilast 20 mg BID

43.5
percentage of participants

Placebo

11.8
percentage of participants

Number of Participants With Adverse Events During the Treatment Phase

The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.

Apremilast 40 mg QD

Adverse events related to study drug

All adverse events

Discontinued due to AE related to study drug

Discontinued study drug due to adverse event

Serious adverse events

Serious adverse events related to study drug

Severe adverse events

Severe adverse events related to study drug

Apremilast 20 mg BID

Adverse events related to study drug

All adverse events

Discontinued due to AE related to study drug

Discontinued study drug due to adverse event

Serious adverse events

Serious adverse events related to study drug

Severe adverse events

Severe adverse events related to study drug

Placebo

Adverse events related to study drug

All adverse events

Discontinued due to AE related to study drug

Discontinued study drug due to adverse event

Serious adverse events

Serious adverse events related to study drug

Severe adverse events

Severe adverse events related to study drug

Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 12

A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures, according to the following: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with no post-baseline PsARC scores were considered non-responders.

Apremilast 40 mg QD

50.7
percentage of participants

Apremilast 20 mg BID

52.2
percentage of participants

Placebo

22.1
percentage of participants

Percentage of Participants With a Modified ACR 50 Response at Week 12

A modified American College of Rheumatology 50% (ACR 50) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.

Apremilast 40 mg QD

13.4
percentage of participants

Apremilast 20 mg BID

17.4
percentage of participants

Placebo

2.9
percentage of participants

Time to ACR 50 Response During the Treatment Phase

The Kaplan-Meier estimates of time to ACR 50 response was calculated for participants who had an ACR 50 response at any time during the treatment phase.

Apremilast 40 mg QD

43.0
days (Median)
95% Confidence Interval: 29.0 to 61.0

Apremilast 20 mg BID

57.5
days (Median)
95% Confidence Interval: 56.0 to 72.0

Placebo

15.0
days (Median)
95% Confidence Interval: 14.0 to 73.0

Time to ACR 70 Response During the Treatment Phase

The Kaplan-Meier estimates of time to ACR 70 response was calculated for participants who had an ACR 70 response at any time during the treatment phase.

Apremilast 40 mg QD

62.0
days (Median)
95% Confidence Interval: 47.0 to 85.0

Apremilast 20 mg BID

57.0
days (Median)
95% Confidence Interval: 43.0 to 85.0

Placebo

58.0
days (Median)
95% Confidence Interval: 31.0 to 85.0

Percentage of Participants With a Modified ACR 70 Response at Week 12

A modified American College of Rheumatology 70% (ACR 70) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.

Apremilast 40 mg QD

7.5
percentage of participants

Apremilast 20 mg BID

5.8
percentage of participants

Placebo

1.5
percentage of participants

Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response Based on Disease Activity Score (DAS28)-CRP(4) at Week 12

The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (TJC; does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count (SJC) • C-reactive protein (CRP) • Patient's global assessment of disease activity (GH) according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2

Apremilast 40 mg QD

49.3
percentage of participants

Apremilast 20 mg BID

55.1
percentage of participants

Placebo

38.2
percentage of participants

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 12

The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = [0.56*√(TJC28) + 0.28*√(SJC28) + 0.36*ln(CRP+1)] * 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2

Apremilast 40 mg QD

50.7
percentage of participants

Apremilast 20 mg BID

44.9
percentage of participants

Placebo

44.1
percentage of participants

Percentage of Participants With DAS28-CRP(4) Score of Mild Disease Activity or In Remission at Week 12

The DAS28-CRP(4) measures the severity of disease derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28-CRP(4) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(4) score of ≤ 3.2. In remission is defined as a DAS28-CRP(4) score of ≤ 2.6.

Apremilast 40 mg QD

38.8
percentage of participants

Apremilast 20 mg BID

33.3
percentage of participants

Placebo

23.5
percentage of participants

Percentage of Participants With DAS28-CRP(3) Score of Mild Disease Activity or In Remission at Week 12

The DAS28-CRP(3) measures the severity of disease derived from the following 3 variables: • 28 tender joint count (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) DAS28-CRP(3) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(3) score of ≤ 3.2. In remission is defined as a DAS28-CRP(3) score of ≤ 2.6.

Apremilast 40 mg QD

40.3
percentage of participants

Apremilast 20 mg BID

34.8
percentage of participants

Placebo

33.8
percentage of participants

Number of Participants Who Withdrew Prematurely Due to Lack of Efficacy

The number of participants who withdrew prematurely from the treatment phase due to lack of efficacy, including flare of psoriasis, flare of psoriatic arthritis or worsening or not responding to study treatment.

Apremilast 40 mg QD

Apremilast 20 mg BID

Placebo

Number of Participants With Adverse Events Leading to a Dose Reduction

The number of participants who were dose reduced during the treatment phase due to adverse events.

Apremilast 40 mg QD

Apremilast 20 mg BID

Placebo

Maximal ACR Response During the Treatment Phase

The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: - percent improvement from Baseline in the 76 swollen joint count, - percent improvement from Baseline in the 78 tender joint count - median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week treatment period was calculated, and represents the maximal ACR response achieved.

Apremilast 40 mg QD

22.3
percent improvement (Mean)
Standard Deviation: 56.45

Apremilast 20 mg BID

24.2
percent improvement (Mean)
Standard Deviation: 37.63

Placebo

10.7
percent improvement (Mean)
Standard Deviation: 35.42

Time to ACR 20 Response During the Treatment Phase

The Kaplan-Meier estimates of time to ACR 20 response was calculated for participants who had an ACR 20 response at any time during the treatment phase.

Apremilast 40 mg QD

29.0
days (Median)
95% Confidence Interval: 29.0 to 43.0

Apremilast 20 mg BID

30.0
days (Median)
95% Confidence Interval: 29.0 to 57.0

Placebo

29.0
days (Median)
95% Confidence Interval: 20.0 to 47.0

Change From Baseline in Dactylitis Severity Score at Week 12

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60.

Apremilast 40 mg QD

-0.9
units on a scale (Mean)
Standard Deviation: 2.39

Apremilast 20 mg BID

-1.2
units on a scale (Mean)
Standard Deviation: 3.11

Placebo

-0.2
units on a scale (Mean)
Standard Deviation: 3.75

Percentage of Participants With Enthesitis

Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.

Apremilast 40 mg QD

Achilles tendon into the calcaneous: Baseline

22.4
percentage of participants

Achilles tendon into the calcaneous: Week 12

20.9
percentage of participants

Plantar fascia into the calcaneous: Baseline

26.9
percentage of participants

Plantar fascia into the calcaneous: Week 12

19.4
percentage of participants

Apremilast 20 mg BID

Achilles tendon into the calcaneous: Baseline

21.7
percentage of participants

Achilles tendon into the calcaneous: Week 12

17.4
percentage of participants

Plantar fascia into the calcaneous: Baseline

26.1
percentage of participants

Plantar fascia into the calcaneous: Week 12

21.7
percentage of participants

Placebo

Achilles tendon into the calcaneous: Baseline

35.3
percentage of participants

Achilles tendon into the calcaneous: Week 12

17.6
percentage of participants

Plantar fascia into the calcaneous: Baseline

14.7
percentage of participants

Plantar fascia into the calcaneous: Week 12

17.6
percentage of participants

Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase

Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit. The time to relapse during the Observational Phase was calculated from the time of maximum ACR reduction and from the date of the Final Treatment Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.

Apremilast 40 mg QD

1. From Week 12

16.0
days (Median)
95% Confidence Interval: 15.0 to 29.0

2. From Date of Maximal ACR Response

43.0
days (Median)
95% Confidence Interval: 34.0 to 73.0

Apremilast 20 mg BID

1. From Week 12

15.0
days (Median)
95% Confidence Interval: 14.0 to 29.0

2. From Date of Maximal ACR Response

29.0
days (Median)
95% Confidence Interval: 22.0 to 43.0

Number of Participants Who Relapsed During the Observational Follow-up Phase

Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit.

Apremilast 40 mg QD

Apremilast 20 mg BID

Change From Baseline in Short Form 36 (SF-36) Summary Physical and Mental Component Scores at Week 12

The Medical Outcome SF 36-Item Health Survey, Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.

Apremilast 40 mg QD

Mental Component

1.0
units on a scale (Mean)
Standard Deviation: 8.01

Physical Component

2.1
units on a scale (Mean)
Standard Deviation: 5.94

Apremilast 20 mg BID

Mental Component

3.4
units on a scale (Mean)
Standard Deviation: 7.18

Physical Component

2.4
units on a scale (Mean)
Standard Deviation: 7.89

Placebo

Mental Component

-0.8
units on a scale (Mean)
Standard Deviation: 8.39

Physical Component

0.8
units on a scale (Mean)
Standard Deviation: 6.24

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12

The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.

Apremilast 40 mg QD

-2.6
units on a scale (Mean)
Standard Deviation: 5.96

Apremilast 20 mg BID

-1.8
units on a scale (Mean)
Standard Deviation: 4.29

Placebo

-0.3
units on a scale (Mean)
Standard Deviation: 4.82

Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).

Apremilast 40 mg QD

-0.2
units on a scale (Mean)
Standard Deviation: 0.39

Apremilast 20 mg BID

-0.2
units on a scale (Mean)
Standard Deviation: 0.35

Placebo

-0.1
units on a scale (Mean)
Standard Deviation: 0.39

Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 12

The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.

Apremilast 40 mg QD

4.3
units on a scale (Mean)
Standard Deviation: 9.46

Apremilast 20 mg BID

4.1
units on a scale (Mean)
Standard Deviation: 8.78

Placebo

0.5
units on a scale (Mean)
Standard Deviation: 8.03

Number of Participants With Adverse Events During the Extension Phase

The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.

Apremilast 40 mg QD

Adverse events related to study drug

All adverse events

Discontinued due to AE related to study drug

Discontinued study drug due to adverse event

Serious adverse events

Serious adverse events related to study drug

Severe adverse events

Apremilast 20 mg BID

Adverse events related to study drug

All adverse events

Discontinued due to AE related to study drug

Discontinued study drug due to adverse event

Serious adverse events

Serious adverse events related to study drug

Severe adverse events

Placebo/Apremilast 40 mg QD

Adverse events related to study drug

All adverse events

Discontinued due to AE related to study drug

Discontinued study drug due to adverse event

Serious adverse events

Serious adverse events related to study drug

Severe adverse events

Placebo/Apremilast 20 mg BID

Adverse events related to study drug

All adverse events

Discontinued due to AE related to study drug

Discontinued study drug due to adverse event

Serious adverse events

Serious adverse events related to study drug

Severe adverse events

Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24

A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with missing data were considered non-responders.

Apremilast 40 mg QD

26.1
percentage of participants

Apremilast 20 mg BID

20.0
percentage of participants

Placebo/Apremilast 40 mg QD

55.0
percentage of participants

Placebo/Apremilast 20 mg BID

40.0
percentage of participants

Percentage of Participants With a Modified ACR 20 Response at Week 24

A modified ACR 20 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.

Apremilast 40 mg QD

Response From Baseline

43.5
percentage of participants

Response From Week 12

16.7
percentage of participants

Apremilast 20 mg BID

Response From Baseline

42.5
percentage of participants

Response From Week 12

14.7
percentage of participants

Placebo/Apremilast 40 mg QD

Response From Baseline

45.0
percentage of participants

Response From Week 12

15.4
percentage of participants

Placebo/Apremilast 20 mg BID

Response From Baseline

40.0
percentage of participants

Response From Week 12

16.7
percentage of participants

Percentage of Participants With a Modified ACR 50 Response at Week 24

A modified ACR 50 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.

Apremilast 40 mg QD

Response From Baseline

23.9
percentage of participants

Response From Week 12

9.7
percentage of participants

Apremilast 20 mg BID

Response From Baseline

22.5
percentage of participants

Response From Week 12

5.9
percentage of participants

Placebo/Apremilast 40 mg QD

Response From Baseline

20.0
percentage of participants

Response From Week 12

15.4
percentage of participants

Placebo/Apremilast 20 mg BID

Response From Baseline

15.0
percentage of participants

Response From Week 12

5.6
percentage of participants

Percentage of Participants With a Modified ACR 70 Response at Week 24

A modified ACR 70 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1). Participants with no post-baseline ACR scores were considered non-responders.

Apremilast 40 mg QD

13.0
percentage of participants

Apremilast 20 mg BID

17.5
percentage of participants

Placebo/Apremilast 40 mg QD

15.0
percentage of participants

Placebo/Apremilast 20 mg BID

5.0
percentage of participants

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(4) at Week 24

The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein • Patient's global assessment of disease activity according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2

Apremilast 40 mg QD

67.4
percentage of participants

Apremilast 20 mg BID

60.0
percentage of participants

Placebo/Apremilast 40 mg QD

70.0
percentage of participants

Placebo/Apremilast 20 mg BID

50.0
percentage of participants

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 24

The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = [0.56*√(TJC28) + 0.28*√(SJC28) + 0.36*ln(CRP+1)] * 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2

Apremilast 40 mg QD

60.9
percentage of participants

Apremilast 20 mg BID

67.5
percentage of participants

Placebo/Apremilast 40 mg QD

65.0
percentage of participants

Placebo/Apremilast 20 mg BID

55.0
percentage of participants

Maximal ACR Response During the Extension Period

The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: • percent improvement from Baseline in the 76 swollen joint count, • percent improvement from Baseline in the 78 tender joint count • median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week extension period was calculated, and represents the maximal ACR response achieved.

Apremilast 40 mg QD

29.1
percent improvement (Mean)
Standard Deviation: 40.86

Apremilast 20 mg BID

30.4
percent improvement (Mean)
Standard Deviation: 36.77

Placebo/Apremilast 40 mg QD

23.3
percent improvement (Mean)
Standard Deviation: 32.11

Placebo/Apremilast 20 mg BID

34.2
percent improvement (Mean)
Standard Deviation: 31.16

Time to ACR 20 Response During the Study

Time to ACR 20 was measured from the first dose of apremilast to the first time a participant achieved an ACR 20 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 20 response were calculated for participants who had an ACR 20 response at any time during the study.

Apremilast 40 mg QD

43.0
days (Median)
95% Confidence Interval: 29.0 to 44.0

Apremilast 20 mg BID

43.0
days (Median)
95% Confidence Interval: 29.0 to 59.0

Placebo/Apremilast 40 mg QD

34.0
days (Median)
95% Confidence Interval: 29.0 to 55.0

Placebo/Apremilast 20 mg BID

55.5
days (Median)
95% Confidence Interval: 29.0 to 57.0

Time to ACR 50 Response During the Treatment and Extension Phase

Time to ACR 50 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 50 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 50 response were calculated for participants who had an ACR 50 response at any time during the study.

Apremilast 40 mg QD

71.0
days (Median)
95% Confidence Interval: 44.0 to 110.0

Apremilast 20 mg BID

58.5
days (Median)
95% Confidence Interval: 56.0 to 86.0

Placebo/Apremilast 40 mg QD

84.5
days (Median)
95% Confidence Interval: 84.0 to 85.0

Placebo/Apremilast 20 mg BID

55.0
days (Median)
95% Confidence Interval: 23.0 to 57.0

Time to ACR 70 Response During the Treatment and Extension Phase

Time to ACR 70 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 70 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 70 response were calculated for participants who had an ACR 70 response at any time during the study.

Placebo/Apremilast 40 mg QD

Placebo/Apremilast 20 mg BID

Apremilast 40 mg QD

138.0
days (Median)
95% Confidence Interval: 85.0 to 169.0

Apremilast 20 mg BID

85.0
days (Median)
95% Confidence Interval: 57.0 to 141.0

Change From Baseline and Week 12 in Dactylitis Severity Score at Week 24

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60. Change in the dactylitis severity score was assessed from Baseline (Day 1) and from Week 12 (Day 85).

Apremilast 40 mg QD

Change from Baseline

-0.4
units on a scale (Mean)
Standard Deviation: 3.47

Change from Week 12

0.3
units on a scale (Mean)
Standard Deviation: 3.07

Apremilast 20 mg BID

Change from Baseline

-1.5
units on a scale (Mean)
Standard Deviation: 3.13

Change from Week 12

-0.2
units on a scale (Mean)
Standard Deviation: 1.97

Placebo/Apremilast 40 mg QD

Change from Baseline

-1.8
units on a scale (Mean)
Standard Deviation: 4.94

Change from Week 12

-0.3
units on a scale (Mean)
Standard Deviation: 0.98

Placebo/Apremilast 20 mg BID

Change from Baseline

0.1
units on a scale (Mean)
Standard Deviation: 1.08

Change from Week 12

-0.8
units on a scale (Mean)
Standard Deviation: 2.39

Percentage of Participants With Enthesitis in the Extension Phase

Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.

Apremilast 40 mg QD

Achilles tendon into the calcaneous: Week 12

17.4
percentage of participants

Achilles tendon into the calcaneous: Week 24

19.6
percentage of participants

Plantar fascia into the calcaneous:Week 12

15.2
percentage of participants

Plantar fascia into the calcaneous: Week 24

13.0
percentage of participants

Apremilast 20 mg BID

Achilles tendon into the calcaneous: Week 12

15.0
percentage of participants

Achilles tendon into the calcaneous: Week 24

15.0
percentage of participants

Plantar fascia into the calcaneous:Week 12

17.5
percentage of participants

Plantar fascia into the calcaneous: Week 24

7.5
percentage of participants

Placebo/Apremilast 40 mg QD

Achilles tendon into the calcaneous: Week 12

20.0
percentage of participants

Achilles tendon into the calcaneous: Week 24

Plantar fascia into the calcaneous:Week 12

25.0
percentage of participants

Plantar fascia into the calcaneous: Week 24

Placebo/Apremilast 20 mg BID

Achilles tendon into the calcaneous: Week 12

20.0
percentage of participants

Achilles tendon into the calcaneous: Week 24

15.0
percentage of participants

Plantar fascia into the calcaneous:Week 12

10.0
percentage of participants

Plantar fascia into the calcaneous: Week 24

10.0
percentage of participants

Time to Relapse of Psoriatic Arthritis After Extension Phase

Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase (Week 24)/Early Termination Visit. The time to relapse during the Follow-up Phase was calculated from the time of maximum ACR reduction and from the date of the Final Extension Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.

Apremilast 40 mg QD

1. From Week 12

31.0
days (Median)
95% Confidence Interval: 29.0

2. From Date of Maximal ACR Response

85.0
days (Median)
95% Confidence Interval: 57.0

Apremilast 20 mg BID

1. From Week 12

32.0
days (Median)
95% Confidence Interval: 29.0 to 38.0

2. From Date of Maximal ACR Response

111.0
days (Median)
95% Confidence Interval: 41.0

Placebo/Apremilast 40 mg QD

1. From Week 12

16.0
days (Median)
95% Confidence Interval: None

2. From Date of Maximal ACR Response

16.0
days (Median)
95% Confidence Interval: None

Placebo/Apremilast 20 mg BID

1. From Week 12

29.0
days (Median)
95% Confidence Interval: 15.0

2. From Date of Maximal ACR Response

29.0
days (Median)
95% Confidence Interval: 15.0

Number of Participants Who Relapsed After the Extension Phase

Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase/Early Termination Visit.

Apremilast 40 mg QD

8.0
participants

Apremilast 20 mg BID

8.0
participants

Placebo/Apremilast 40 mg QD

1.0
participants

Placebo/Apremilast 20 mg BID

2.0
participants

Change From Baseline and Week 12 in SF-36 at Week 24

The Medical Outcome SF 36-Item Health Survey, Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.

Apremilast 40 mg QD

Mental Component: Change from Baseline

0.2
units on a scale (Mean)
Standard Deviation: 9.08

Mental Component: Change from Week 12

-1.1
units on a scale (Mean)
Standard Deviation: 8.14

Physical Component: Change from Baseline

3.2
units on a scale (Mean)
Standard Deviation: 6.68

Physical Component: Change from Week 12

0.3
units on a scale (Mean)
Standard Deviation: 6.10

Apremilast 20 mg BID

Mental Component: Change from Baseline

1.4
units on a scale (Mean)
Standard Deviation: 8.92

Mental Component: Change from Week 12

-2.4
units on a scale (Mean)
Standard Deviation: 9.35

Physical Component: Change from Baseline

4.4
units on a scale (Mean)
Standard Deviation: 7.74

Physical Component: Change from Week 12

1.0
units on a scale (Mean)
Standard Deviation: 6.60

Placebo/Apremilast 40 mg QD

Mental Component: Change from Baseline

-2.7
units on a scale (Mean)
Standard Deviation: 12.20

Mental Component: Change from Week 12

-2.5
units on a scale (Mean)
Standard Deviation: 10.60

Physical Component: Change from Baseline

1.8
units on a scale (Mean)
Standard Deviation: 9.50

Physical Component: Change from Week 12

-0.1
units on a scale (Mean)
Standard Deviation: 8.50

Placebo/Apremilast 20 mg BID

Mental Component: Change from Baseline

-1.0
units on a scale (Mean)
Standard Deviation: 14.00

Mental Component: Change from Week 12

-3.4
units on a scale (Mean)
Standard Deviation: 10.61

Physical Component: Change from Baseline

4.2
units on a scale (Mean)
Standard Deviation: 9.99

Physical Component: Change from Week 12

2.5
units on a scale (Mean)
Standard Deviation: 7.81

Change From Baseline and Week 12 in Dermatology Life Quality Index (DLQI) at Week 24

The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much) The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.

Apremilast 40 mg QD

Change from Baseline

-3.0
units on a scale (Mean)
Standard Deviation: 7.36

Change from Week 12

Apremilast 20 mg BID

Change from Baseline

-1.5
units on a scale (Mean)
Standard Deviation: 4.08

Change from Week 12

-0.1
units on a scale (Mean)
Standard Deviation: 3.54

Placebo/Apremilast 40 mg QD

Change from Baseline

-2.6
units on a scale (Mean)
Standard Deviation: 4.78

Change from Week 12

-1.2
units on a scale (Mean)
Standard Deviation: 2.07

Placebo/Apremilast 20 mg BID

Change from Baseline

-1.9
units on a scale (Mean)
Standard Deviation: 5.50

Change from Week 12

-2.0
units on a scale (Mean)
Standard Deviation: 6.25

Change From Baseline and Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24

The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).

Apremilast 40 mg QD

Change from Baseline

-0.1
units on a scale (Mean)
Standard Deviation: 0.45

Change from Week 12

Apremilast 20 mg BID

Change from Baseline

-0.2
units on a scale (Mean)
Standard Deviation: 0.37

Change from Week 12

Placebo/Apremilast 40 mg QD

Change from Baseline

-0.1
units on a scale (Mean)
Standard Deviation: 0.61

Change from Week 12

Placebo/Apremilast 20 mg BID

Change from Baseline

-0.2
units on a scale (Mean)
Standard Deviation: 0.59

Change from Week 12

-0.2
units on a scale (Mean)
Standard Deviation: 0.44

Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 24

The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.

Apremilast 40 mg QD

Change from Baseline

4.4
units on a scale (Mean)
Standard Deviation: 9.76

Change from Week 12

-0.3
units on a scale (Mean)
Standard Deviation: 8.56

Apremilast 20 mg BID

Change from Baseline

5.9
units on a scale (Mean)
Standard Deviation: 7.76

Change from Week 12

0.1
units on a scale (Mean)
Standard Deviation: 6.19

Placebo/Apremilast 40 mg QD

Change from Baseline

1.3
units on a scale (Mean)
Standard Deviation: 11.23

Change from Week 12

-2.4
units on a scale (Mean)
Standard Deviation: 9.05

Placebo/Apremilast 20 mg BID

Change from Baseline

1.3
units on a scale (Mean)
Standard Deviation: 12.34

Change from Week 12

-1.3
units on a scale (Mean)
Standard Deviation: 13.10

Total

204
Participants

Age, Continuous

50.6
years (Mean)
Standard Deviation: 11.50

Duration of Psoriasis

16.5
years (Mean)
Standard Deviation: 12.85

Duration of Psoriatic Arthritis

7.8
years (Mean)
Standard Deviation: 8.48

Pain/Tender Joint Score

21.7
joints (Mean)
Standard Deviation: 16.33

Swollen Joint Score

9.5
joints (Mean)
Standard Deviation: 8.51

Methotrexate Use

Psoriasis Severity

Psoriatic Arthritis Disease Category

Race/Ethnicity, Customized

Sex: Female, Male

Extension Phase

Apremilast 40 mg QD

Apremilast 20 mg BID

Placebo/Apremilast 40 mg QD

Placebo/Apremilast 20 mg BID

Treatment Phase (12 Weeks)

Apremilast 40 mg QD

Apremilast 20 mg BID

Placebo

Drop/Withdrawal Reasons

Apremilast 40 mg QD

Apremilast 20 mg BID

Placebo

Placebo/Apremilast 40 mg QD

Placebo/Apremilast 20 mg BID