Artikel
A Double-blind Phase 3 Study of Efficacy and Safety of Ixekizumab, Adalimumab, and Placebo in Patients Naïve to Biologic Disease modifying Antirheumatic Drugs with Psoriatic Arthritis
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Veröffentlicht: | 29. August 2016 |
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Gliederung
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Background: Ixekizumab (IXE) is an anti-IL-17A monoclonal antibody under investigation for PsA treatment.
Methods: 417 biologic disease modifying antirheumatic drug (bDMARD)-naive patients with active psoriatic arthritis (PsA) were randomized to placebo (PBO; N=106), adalimumab (ADA) 40mg Q2W (N=101), or IXE 80mg Q2W (N=103) or Q4W (N=107) after an initial 160mg dose. Endpoints included ACR20 response at 24 weeks (primary), ACR50/70, PASI75/90/100, DAS28-CRP, LDI-B, LEI, and HAQ-DI (12 and 24 weeks), and mTSS (16 and 24 weeks).
Results: 382 patients completed 24 weeks: 30.2%, 57.4%, 62.1% and 57.9% of PBO-, ADA-, IXE Q2W- and IXE Q4W patients, respectively, had ACR20 responses. At 12 (ACR70 not eligible for comparison) and 24 weeks, a higher percentage of IXE Q2W/IXE Q4W- than PBO patients achieved ACR20/50/70 and PASI75/90/100 responses (p≤.001).IXE groups experienced greater reductions than PBO in LDI-B (p≤.025) and LEI (Week 12 Q2W only; p≤.05) (Table). DAS28-CRP and HAQ-DI scores improved, and both IXE doses inhibited radiographic progression of joint structural damage (mTSS) (p≤.025 vs PBO). 24-week treatment-emergent adverse events (TEAE) incidence was higher (p≤.025) with IXE and ADA vs PBO. Discontinuation due to TEAE was similar across groups. No deaths occurred.
Conclusion: IXE patients showed greater disease marker improvement than PBO and no unexpected safety findings were observed in bDMARD-naive patients with PsA.