Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial

The Lancet ◽  
2017 ◽  
Vol 389 (10086) ◽  
pp. 2317-2327 ◽  
Author(s):  
Peter Nash ◽  
Bruce Kirkham ◽  
Masato Okada ◽  
Proton Rahman ◽  
Benard Combe ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Inadequate Response ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Tumour Necrosis Factor Inhibitors ◽  
Necrosis Factor

scholarly journals Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS)

2021 ◽  
pp. annrheumdis-2021-220991
Author(s):  
Laura C Coates ◽  
Laure Gossec ◽  
Elke Theander ◽  
Paul Bergmans ◽  
Marlies Neuhold ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Opportunistic Infections ◽  
Controlled Study ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Acr20 Response ◽  
Tumour Necrosis Factor Inhibitors ◽  
Necrosis Factor

ObjectiveTo evaluate efficacy and safety of guselkumab, an anti-interleukin-23p19-subunit antibody, in patients with psoriatic arthritis (PsA) with prior inadequate response (IR) to tumour necrosis factor inhibitors (TNFi).MethodsAdults with active PsA (≥3 swollen and ≥3 tender joints) who discontinued ≤2 TNFi due to IR (lack of efficacy or intolerance) were randomised (2:1) to subcutaneous guselkumab 100 mg or placebo at week 0, week 4, then every 8 weeks (Q8W) through week 44. Patients receiving placebo crossed over to guselkumab at week 24. The primary (ACR20) and key secondary (change in HAQ-DI, ACR50, change in SF-36 PCS and PASI100) endpoints, at week 24, underwent fixed-sequence testing (two-sided α=0.05). Adverse events (AEs) were assessed through week 56.ResultsAmong 285 participants (female (52%), one (88%) or two (12%) prior TNFi), 88% of 189 guselkumab and 86% of 96 placebo→guselkumab patients completed study agent through week 44. A statistically significantly higher proportion of patients receiving guselkumab (44.4%) than placebo (19.8%) achieved ACR20 (%difference (95% CI): 24.6 (14.1 to 35.2); multiplicity-adjusted p<0.001) at week 24. Guselkumab was superior to placebo for each key secondary endpoint (multiplicity-adjusted p<0.01). ACR20 response (non-responder imputation) in the guselkumab group was 58% at week 48; >80% of week 24 responders maintained response at week 48. Through week 24, serious AEs/serious infections occurred in 3.7%/0.5% of 189 guselkumab-randomised and 3.1%/0% of 96 placebo-randomised patients; the guselkumab safety profile was similar through week 56, with no deaths or opportunistic infections.ConclusionGuselkumab significantly improved joint and skin manifestations and physical function in patients with TNFi-IR PsA. A favourable benefit–risk profile was demonstrated through 1 year.Trial registration numberNCT03796858.

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