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Upadacitinib improves health-related QoL in difficult-to-treat RA
Among those with rheumatoid arthritis who previously had an inadequate response to biologic DMARDs, upadacitinib, in doses of either 15 mg or 30 mg, increased quality of life and resulted in more patients reaching clinically meaningful improvements, according to data published in Arthritis Research & Therapy.
“Rheumatoid arthritis is a chronic disease associated with reduced health-related quality of life, therefore, patient-reported outcomes are important to consider when evaluating treatment benefits in patients with RA,” Vibeke Strand, MD, MACR, FACP, of Stanford University, told Healio Rheumatology. “This study compared upadacitinib,15 mg and 30 mg, with placebo to evaluate clinically meaningful improvements in PROs in RA patients who previously had inadequate responses to biologic disease-modifying antirheumatic drugs.”
In addition, in their article, Strand and colleagues wrote, “The [SELECT-BEYOND trial] demonstrated that significantly more upadacitinib-treated patients had American College of Rheumatology 20% improvement (ACR20) responses and lower disease activity than placebo.”
Continuing their analyses of the SELECT-BEYOND phase 3 trial, Strand and colleagues aimed to evaluate patient-related outcomes with upadacitinib (Rinvoq, AbbVie), compared with placebo, among patients with RA and inadequate responses to biologic DMARDs. According to the researchers, the trial included adult patients who had had moderate-to-severe RA for at least 3 months, and were randomized 1:1:1 to receive a daily regimen of either oral upadacitinib 15 mg, oral upadacitinib 30 mg or placebo for 12 weeks. Patients were excluded if they had previous treatment with a JAK inhibitor.
A total of 164 patients were treated with 15 mg of upadacitinib, with 165 treated with 30 mg and 169 received placebo. Improvement measures included Patient Global Assessment of Disease Activity (PtGA), Health Assessment Questionnaire Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), duration and severity of morning stiffness, Insomnia Severity Index (ISI) and pain.
In addition, the researchers calculated least squares mean changes, as well as the percentage of patients reported improvements greater or equal to the minimum clinically important differences, and scores greater than or equal to normative values. Lastly, they determined the number needed to treat to achieve clinically meaningful improvements.
According to the researchers, both upadacitinib groups reported statistically significant improvements from baseline vs. placebo in PtGA, pain, HAQ-DI, the SF-36 Physical Component Summary, and morning stiffness duration and severity. In addition, the 15 mg group experienced statistically significant improvements in seven out of eight SF-36 domains, while the 30 mg group saw similar changes in six SF-36 domains.
Compared with placebo, more patients treated with upadacitinib reported improvements greater or equal to minimum clinically important differences in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary, and morning stiffness duration and severity. This finding was also reported in seven of the eight SF-36 domains among patients in the 15 mg group, in ISI and in five of the SF-36 domains in the 30 mg group. In addition, more patients treated with upadacitinib reported scores greater or equal to normative values in HAQ-DI and SF-36 domains, compared with placebo.
The number need to treat to achieve minimum clinically important differences with upadacitinib ranged from four to seven patients across most patient-reported outcomes.
“Clinically relevant improvements in PROs assessing different aspects of disease burden were reported in this difficult to treat population with both doses of upadacitinib, 15 mg and 30 mg, having an equally effective impact on most PROs,” Strand said.
“These PRO data complement the positive improvements in RA signs and symptoms observed with upadacitinib treatment in prior clinical trials and suggest that upadacitinib may be an effective and important oral treatment option in patients with active and refractory RA,” she added. “Indeed, upadacitinib 15 mg was recently approved by FDA for the treatment of patients with moderately to severely active RA with an inadequate response to methotrexate.” – by Jason Laday
Disclosure: Strand reports consulting fees from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi and UCB, as well as advisory board involvement with AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB. Please see the full study for all other authors’ relevant disclosures.