Cytokine Signalling Forum

Publications




Safety and Effectiveness of Upadacitinib or Adalimumab Plus Methotrexate in Patients with Rheumatoid Arthritis Over 48 Weeks with Switch to Alternate Therapy in Patients with Insufficient Response

Fleischmann RM, Genovese MC,  Enejosa JV,  Mysler E, Bessette L, Peterfy C,  Ostor P,  Li Y,  Song I. - Ann Rheum Dis 2019 DOI: 10.1136/annrheumdis-2019-215764

Consistent with Wk26 data, significantly more UPA patients achieved LDA and remission versus ADA and PBO over 48 weeks. RA patients often change therapy due to inadequate response and intolerance. The SELECT COMPARE study was designed to explore switching to JAK inhibitors from TNF inhibitors without a wash-out period (and vice versa). The long-term safety and efficacy of UPA was compared to ADA and PBO in MTX-IR.

1629 patients were blindly assigned 2:2:1 to; UPA 15mg QD, ADA 40mg Q2W and PBO, with background MTX. Efficacy and safety measures included; CDAI, SDAI, DAS28-ESR, and AEs. Patients with <20% improvement in TJC/SJC or CDAI >10 were rescued. Non responders in PBO and ADA groups were rescued to UPA, whilst UPA non-responders were rescued to ADA.

Safety was comparable at Wk48 to Wk26, in both continuing and rescued patient populations, with no new safety concerns raised. Rescue was beneficial regardless of the drug changed to, however improvement was greater in patients switching from ADA to UPA versus UPA to ADA. The authors concluded that the long-term safety and efficacy at Wk48 was consistent with the primary findings at Wk26.