Upadacitinib Shows Significant Efficacy in the Treatment of Moderate RA

Upadacitinib was found to improve clinical and patient-reported outcomes among patients with moderate and severe rheumatoid arthritis (RA) disease activity, according to study results published in Rheumatology Advances in Practice.

Researchers in the UK conducted a post hoc analysis of 4 phase 3 trials (SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, and SELECT-BEYOND) to explore the efficacy of upadacitinib in the treatment of moderately active RA.

Participants were aged 18 years and older and received upadacitinib 15 mg once-daily, as monotherapy after switching from methotrexate (MTX) or in combination with stable background conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy, or placebo with continued MTX or csDMARD therapy.

Outcomes were analyzed separately for patients with moderate (Disease Activity Score [DAS] 28 between >3.2 and 5.1) and severe (DAS28 of >5.1). Primary study endpoint included achievement of 20% improvement in the American College Rheumatology criteria (ACR20) and the percentage of individuals meeting the criteria for low disease activity, defined as a DAS28 using C-reactive protein (DAS28-CRP of 3.2 or lower  and remission (DAS28-CRP <2.6).

Patient-reported outcomes were also evaluated at baseline and week 12 or 14.

Individuals with radiographic progression at week 26 were evaluated based on the van der Heijde modified total sharp score (mTSS).

After analyses, investigators Researchers found that a significantly greater percentage of patients with an inadequate response to csDMARDs with moderate RA who received upadacitinib 15 mg (as either combination or monotherapy) achieved the ACR20. In addition, a greater percentage of individuals achieved remission criteria with upadacitinib, both as combination and monotherapy, vs placebo at week 12 or 14.

Researchers observed similar results for individuals with severe disease activity at baseline.

Significant patient-reported physical function improvements were also observed at week 12 or 14 with upadacitinib 15 mg vs placebo for the moderate and severe disease group.

Researchers indicated that radiographic progression at week 26 was reduced with upadacitinib 15 mg compared with placebo among participants with moderate disease activity (mean change, 0.166 vs 0.128; P <.05). Similar results were seen for participants with severe disease activity (mean change, 0.362 vs 1.130; P <.001).

The study was limited by the short follow-up period. In addition, radiographic data were only available from the SELECT-COMPARE trial; therefore, limited inferences were drawn regarding structural outcomes. The study authors concluded, “These findings provide new evidence in support of the use of advanced therapies, such as UPA, for the treatment of patients with RA with moderate disease activity, in addition to those with more severe disease.”

Disclosure: This research was supported by AbbVie. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.