Positive topline data were announced from the phase 3 SELECT-PsA 1 study of upadacitinib, a Janus Kinase (JAK) inhibitor, in adult patients with active psoriatic arthritis who have had an inadequate response to at least 1 nonbiologic disease modifying antirheumatic drug (DMARD).
The phase 3, multicenter, double-blind study compared the efficacy and safety of upadacitinib with placebo and adalimumab. Patients were randomized to receive upadacitinib 15mg or 30mg once daily, adalimumab 40mg every 2 weeks, or placebo followed by either upadacitinib 15mg or 30mg at week 24. The primary end point was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 12.
Results showed that both doses of upadacitinib achieved noninferiority at week 12 compared with adalimumab, with the 30mg dose showing superiority. Patients treated with upadacitinib 15mg and 30mg achieved the following statistically significant ACR responses at week 12 vs placebo:
- ACR20 of 71% and 79%, respectively, vs 36% (P <.0001)
- ACR50 of 38% and 52%, respectively, vs 13% (nominal P <.0001)
- ACR70 of 16% and 25%, respectively, vs 2% (nominal P <.0001)
Additionally, upadacitinib 15mg and 30mg were associated with statistically significant improvements for key secondary end points including:
- Change from baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at week 12: -0.42 and -0.47, respectively, compared with -0.14 with placebo (P <.0001)
- Psoriasis Area Severity Index (PASI 75) at week 16: 63% and 62% of patients, respectively, compared with 21% with placebo (P <.0001)
- Minimal disease activity (MDA) at week 24: 37% and 45% of patients, respectively, compared with 12% with placebo (P <.0001)
Both doses of upadacitinib also showed significant inhibition of radiographic progression, as measured by the change from baseline in modified PsA Sharp/van der Heijde Score, compared with placebo (P <0.01). With regard to safety, upadacitinib demonstrated a profile consistent with that seen in previous clinical studies.
Full study results will be presented at a future medical meeting and published in a peer-reviewed publication.
“The results of SELECT-PsA 1 showed that both doses of upadacitinib demonstrated significantly greater efficacy in joint and skin symptoms, as well as inhibition of radiographic progression, compared to placebo,” said Professor Iain McInnes, FRCP, PhD, University of Glasgow Institute of Infection, Immunity & Inflammation. “These data are encouraging and add to the growing body of evidence that upadacitinib has the potential to improve outcomes for people living with psoriatic arthritis.”
Upadacitinib is currently marketed under the brand name Rinvoq and is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
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