Phase 4
Completed N=566
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
Source: ClinicalTrials.gov NCT03151551 ↗Enrolled (actual)
566
Serious AEs
5.3%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) — 36; 27.9 percentage of participants — p=0.036
◆ Published Evidence
Established
44citations · ~7 / year
Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study.
Summary
The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.
Linked Publications (5)
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Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study.
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Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure.
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Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
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A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
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Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) |
36; 27.9 | 0.036 sig |
| SECONDARY Percentage of Participants Achieving ACR50 |
50.5; 46.6 | — |
| SECONDARY Percentage of Participants Achieving PASI100 |
60.1; 46.6 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
- Presence of active plaque psoriasis with a BSA ≥3%
- Men must agree to use a reliable method of birth control or remain abstinent during the study
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
Exclusion Criteria
- Current or prior use of biologic agents for treatment of Ps or PsA
- Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- Serious disorder or illness other than psoriatic arthritis
- Serious infection within the last 3 months
- Active Crohn's disease or active ulcerative colitis
- Active vasculitis or uveitis
- Diagnosis of or history of malignant disease <5 years prior to randomization
- Women who are breastfeeding
Data sourced from ClinicalTrials.gov (NCT03151551) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.