Highlights from

ACR 2020

ACR Convergence 2020

Virtual 5 - 9 November 2020

Long-term oral JAK inhibition demonstrates sustained benefit in RA patients

In the SELECT-MONOTHERAPY study, continuous efficacy and consistent safety of the oral JAK inhibitor upadacitinib was observed for the treatment of rheumatoid arthritis (RA) over 84 weeks.

Upadacitinib has already shown significant results after 14 weeks in treating patients with moderate-to-severe RA compared to methotrexate within the SELECT-MONOTHERAPY study. The current analysis focused on drug performance over 84 weeks [1].

Within the long-term extension of SELECT-MONOTHERAPY, 598 patients continued their previous medication with upadacitinib 15 or 30 mg, or in case of a preceding methotrexate therapy were switched to one of the upadacitinib doses, as prespecified at baseline.

“By week 84, approximately 80% of patients in either treatment group, blinded upadacitinib 15 or 30 mg, remained in the study,” said Prof. Josef Smolen (Medical University of Vienna, Austria). Baseline characteristics were balanced over the different treatment groups. They comprised 81% females, a mean of 6.6 years since RA diagnosis, and several indicators for disease activity: mean Disease Activity Score (DAS)28 using c-reactive protein (CRP) was 5.6, mean clinical disease activity index (CDAI) was 38.0. In total, exposure to upadacitinib 15 mg corresponded to 421.5 patient years (PY) and 425.9 PY of upadacitinib 30 mg.

Treatment-emerging adverse events happened in the upadacitinib groups at a rate of ≥5/100 PY and were most frequently seen as urinary tract infections, creatine phosphokinase (CPK) elevation, or upper respiratory tract infections. “Events of herpes zoster, hepatic disorders, and CPK elevation were higher among patients receiving upadacitinib 30 mg, while rates of serious infections and malignancy appeared comparable between the doses,” revealed Prof. Smolen regarding long-term safety. The most common serious adverse event was pneumonia, occurring at 1.7 events/100 PY in the upadacitinib 15 mg group and 0.7 events/100 PY in the upadacitinib 30 mg group.

Concerning efficacy, 71% (upadacitinib 15 mg) and 78% (upadacitinib 30 mg) reached American College of Rheumatology (ACR)50 responses at week 84. The respective rates for DAS28 <2.6 were 60% and 77%, respectively. CDAI ≤10 was attained by 55% (upadacitinib 15 mg) and 67% (upadacitinib 30 mg). “Approximately one-quarter to one-third of patients receiving upadacitinib achieved CDAI and ACR/EULAR-based Boolean definitions of remission at week 84,” said Prof. Smolen. Furthermore, reductions in pain and physical function were also maintained until week 84.

“In summary, upadacitinib monotherapy resulted in continued and sustained benefit through 84 weeks with no new safety signals identified,” concluded Prof. Smolen.

  1. Smolen JS, et al. Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks. P0209, ACR Convergence 2020 Virtual Annual Meeting, 5-9 November 2020.

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