Compared with placebo, upadacitinib was found to provide clinically meaningful improvements in patient-reported outcomes (PROs) in those with biologic disease-modifying antirheumatic drug (bDMARD)-refractory rheumatoid arthritis (RA), according to research published in Arthritis Research & Therapy.
The researchers conducted a post hoc analysis of data for 498 patients from a phase 3 (A Study to Compare Upadacitinib [ABT-494] to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs [csDMARDs] With an Inadequate Response or Intolerance to Biologic DMARDs [SELECT-BEYOND]; ClinicalTrials.gov Identifier: NCT02706847) study. The randomized study evaluated the use of upadacitinib (15 mg or 30 mg) or placebo in patients with RA who did not respond adequately to bDMARD therapy. PRO responses between groups were compared using standardized assessment tools, including the Patient Global Assessment of Disease Activity, Short Form-36 Health Survey (SF-36), and Health Assessment Questionnaire Disability Index. Standard statistical methods were used to measure clinically meaningful responses for each PRO.
After analysis, the researchers found that upadacitinib (15 mg and 30 mg) significantly improved pain, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire Disability Index, morning stiffness, and SF-36 Physical Component Summary scores compared with placebo at 12 weeks (all P ≤.001).
From baseline, the duration of morning stiffness was lowered by 58% and 43% in the upadacitinib 30-mg and 15-mg dosing groups, respectively.
In addition, statistically significant changes were observed across all SF-36 domains in the upadacitinib 15-mg dosing group compared with placebo, with the exception of the SF-36 mental health domain.
“Overall, upadacitinib showed improvements in PROs that were better or comparable to those seen with the [interleukin]-6 receptor antagonist or other [Janus kinase] inhibitors,” the researchers reported.
One key limitation of the study was the short duration of follow-up. As a result, whether these changes will be maintained long-term is unknown.
“Upadacitinib may be a treatment option for bDMARD-inadequate responder patients with RA providing clinically significant relief from symptoms that impair [health-related quality of life] ,” they concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry.
Please see the original reference for a full list of authors’ disclosures.
Strand V, Schiff M, Tundia N, et al. Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Arthritis Res Ther. 2019;21(1):263.