Rheumatology and therapy
Long-Term Safety and Efficacy of Upadacitinib in Patients with Psoriatic Arthritis: 5-Year Results from the Phase 3 SELECT-PsA 1 Study
By McInnes IB, Kato K, Magrey M and 9 others.
Abstract
Introduction
In the phase 3 SELECT-PsA 1 study, treatment with upadacitinib (UPA), an oral Janus kinase (JAK) inhibitor, improved signs and symptoms of psoriatic arthritis (PsA) from weeks 12 through 152. We now report the long-term extension phase, evaluating safety and efficacy of upadacitinib versus adalimumab (ADA) up to week 260 (~ 5 years).
Methods
Data on treatment-emergent adverse events and all primary and secondary endpoints were collected through week 260 for patients who received a placebo or ≥ 1 dose of UPA at either 15 mg (UPA15) or 30 mg (UPA30) daily, or ADA 40 mg every other week. For non-radiographic binary endpoints, both observed data and non-responder imputation methods were used, whereas for radiographic binary endpoints, the observed data method was used. For continuous endpoints, observed data and mixed-effects model repeated-measures analyses were employed.