Upadacitinib effective in patients with RA who failed prior TNF inhibitor therapy
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PHILADELPHIA — Among patients with rheumatoid arthritis who had an inadequate response or intolerance to TNF inhibitors, upadacitinib demonstrated clinically meaningful and improved efficacy over 24 weeks, according to a post-hoc analysis.
The analysis was presented at ACR Convergence 2022.
“For patients with RA and an inadequate response to TNF inhibitor therapy, the likelihood of achieving optimal disease control with subsequent therapy declines with an increase in number of TNF inhibitor treatment,” Roy Fleischmann, MD, clinical professor of medicine at the University of Texas Southwestern Medical Center and medical director of the Metroplex Clinical Research Center, said in a poster presentation. “In line with treatment guidelines, switching to a treatment with a different mechanism of action, like a JAK inhibitor, is appropriate for these patients.”
According to the poster, the post-hoc subgroup analysis included patients from SELECT-BEYOND, SELECT-CHOICE, and SELECT-COMPARE phase 3 trials. In BEYOND, patients who were refractory to biologic disease-modifying antirheumatic drugs and were treated with 15 mg of upadacitinib (Rinvoq, AbbVie) or placebo. In CHOICE, patients who were refractory to DMARDS and were treated with 15 mg of upadacitinib or abatacept (Orencia, Bristol Myers Squibb). Finally, in COMPARE, patients who were refractory to methotrexate and treated with 15 mg of upadacitinib or adalimumab (Humira, AbbVie). However, only patients who were randomized to receive adalimumab but were eventually switched to upadacitinib as rescue therapy in COMPARE were included in the final subgroup analysis.
Efficacy outcomes were reported through 24 weeks and determined by ACR20, ACR50, and ACR70% ACR criteria, DAS28-CRP, Clinical Disease Activity Index, Simple Disease Activity Index, change from baseline in HAQ-DI, and other patient-reported outcomes.
According to the poster, the analysis included 568 patients, with 146 coming from BEYOND, 263 coming from CHOICE, and 159 coming from COMPARE. Of the patients from BEYOND, 62.3% failed one prior TNF inhibitor because of lack or loss of efficacy compared with 70.3% from CHOICE and 100% from COMPARE. The rest of the patients failed two or more prior TNF inhibitors, and the researchers reported that cardiovascular risk factors were common among this population.
Fleischmann and colleagues reported that among patients with an inadequate response or intolerance to TNF inhibitors included in the subgroup analysis, the 20/50/70% ACR and other disease activity outcomes achieved were consistent with the overall refractory DMARD patients in BEYOND and CHOICE. The outcomes were also consistent across all three studies in the inadequate response or intolerance to TNF inhibitors subgroups.
“We report clinically meaningful and improved efficacy responses over 24 weeks for patients with RA receiving upadacitinib who’ve had a previous inadequate response or intolerance to TNF inhibitor therapy,” Fleischmann said. “The benefit-risk profile of upadacitinib in this TNF inhibitor inadequate responded population is similar to that observed in the overall biologic DMARD inadequate responded population from the SELECT clinical trial program.”
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Fleischmann R, et al. Abstract 0282. Presented at: ACR Convergence 2022; November 11-14, 2022; Philadelphia (hybrid meeting).
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