A new study compared the impact of upadacitinib versus placebo on patient-reported outcomes (PROs) and quality of life (QOL) among patients with rheumatoid arthritis (RA) who had inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARD-IR).
“Despite several treatment options, a significant proportion of patients with RA become refractory, or do not adequately respond, to available therapies. … Several classes of drugs are available to treat inflammation and thereby provide relief from symptoms associated with RA,” the researchers explained. “Current treatment options include conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) such as methotrexate (MTX), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs). Janus kinase (JAK) inhibitors are a new class of tsDMARDs approved for use in RA.”
“The objectives of the following analyses are to compare response rates and numbers needed to treat (NNTs) with upadacitinib versus placebo for PROs and assess the achievement of clinically meaningful improvements and normative values in patients with treatment-refractory RA,” they added. The study was published in Arthritis Care & Research.
SELECT-BEYOND was a phase 3 randomized trial. This paper highlighted 12-week data on PRO responses between between upadacitinib 15 mg or 30 mg versus placebo. Comparisons were made between Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), duration and severity of morning (AM) stiffness, and Insomnia Severity Index (ISI).
Final analysis included 498 patients: 164 in the upadacitinib 15 mg group, 165 in the upadacitinib 30 mg group, and 169 in the placebo group; mean age at baseline was similar among the groups (56.3 years, 57.3 years, and 57.6 years, respectively), as was RA disease duration (12.4 years, 12.7 years, and 14.5 years, respectively). Compared to placebo, both upadacitinib doses were associated with statistically significant improvements in baseline PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 7 of 8 SF-36 domains (15 mg), 6 of 8 SF-36 domains (30 mg), and AM stiffness duration and severity. Upadacitinib patients were more likely than placebo patients to report improvements greater than or equal to the minimal clinically important difference (MCID) in PtGA, pain, HAQ-DI, SF-36 PCS, 7 of 8 SF-36 domains (15 mg), 5 of 8 SF-36 domains (30 mg), AM stiffness duration and severity, and ISI (30 mg); upadacitinib patients were also more likely to have scores greater than or equal to normative values in HAQ-DI and SF-36 domains. Spanning most of the PROs, NNTs to attain MCID ranged from four to seven patients treated with upadacitinib.
The researchers concluded that “in difficult-to-treat bDMARD-IR patients with active RA, treatment with upadacitinib compared with placebo resulted in significantly more patients with clinically meaningful improvements in PROs and responses that approached normative values. Furthermore, the NNTs to achieve clinically meaningful responses were ≤ 10, which are generally considered favorable. Upadacitinib may be a treatment option for bDMARD-IR patients with RA providing clinically significant relief from symptoms that impair [health-related] QOL.”