Upadacitinib monotherapy improves patient-reported outcomes in MTX-naïve, refractory RA
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Upadacitinib monotherapy improves patient-reported pain, physical function, morning stiffness and other measures in those with rheumatoid arthritis who never received, or had an inadequate response to, methotrexate, according to data.
“Upadacitinib (UPA), a selective JAK1 inhibitor, is approved for the treatment of adults with moderately to severely active RA with an inadequate response to methotrexate (MTX-IR) and has shown superior efficacy as monotherapy over MTX in both MTX-naïve and MTX-IR patients,” Vibeke Stand, MD, MACR, FACP, of the Stanford University School of Medicine, and colleagues wrote in Rheumatology.
“The recommended dose of UPA for the treatment of moderately to severely active RA in adults is 15mg once daily,” they added. “Substantial improvements in patient-reported outcomes (PROs) have been reported with UPA in combination with MTX in patients with inadequate responses to csDMARDs or bDMARDs, but the impact of UPA monotherapy on PROs remains to be established.”
To analyze the impact of upadacitinib (Rinvoq, AbbVie) monotherapy, compared with MTX, on patient-reported outcomes among those who had not yet received, or had inadequate response to, MTX, Strand and colleagues examined data from the SELECT-EARLY and SELECT-MONOTHERAPY trials. According to the researchers, these phase 3, randomized controlled studies enrolled adults who had experienced RA symptoms for at least 6 weeks — in SELECT-EARLY — or had been diagnosed with RA for at least 3 months — in SELECT-MONOTHERAPY.
Participants who were MTX-naïve were randomized 1:1:1 to receive either 15 or 30 mg upadacitinib daily, or weekly MTX. Meanwhile, those with an inadequate response to MTX prior to enrollment were randomized 1:1:1 to either discontinue MTX and instead receive 15 or 30 mg daily upadacitinib monotherapy, plus placebo MTX, or continue previous MTX monotherapy doses plus upadacitinib placebo.
For this study, Strand and colleagues focused on data from the first 12 weeks of the SELECT-EARLY study and the first 14 weeks of SELECT-MONOTHERAPY. Patient-reported outcomes included Patient Global Assessment of Disease Activity (PtGA), pain visual analogue scale, HAQ Disability Index (HAQ-DI), morning stiffness duration and severity, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, health-related quality of life (HRQOL) by the 36-iem Short Form Health Survey, and Work Productivity and Activity Impairment (WPAI).
Data analysis included least square mean (LSM) changes, as well as the proportions of patients who reported improvements greater than or equal to the minimum clinically important differences and normative values.
In all, 945 MTX-naïve participants, and 648 with a prior inadequate response, were included in the analysis.
According to the researchers, upadacitinib monotherapy, compared with MTX, demonstrated greater reported LSM changes from baseline at week 12 — for SELECT-EALY — and week 14 — for SELECT-MONOTHERAPY — in PtGA, pain, HAQ-DI, morning stiffness duration and severity, FACIT-F, HRQOL and WPAI. These changes were statistically significant with both the 15 and 30 mg doses of upadacitinib, compared with MTX, in both trials. Patient-reported improvements were noted as early as week 2.
In addition, more patients treated with upadacitinib, compared with MTX, reported improvements greater than or equal to the minimum clinically important differences, as well as scores greater than or equal to normative values.
“MTX-naïve and MTX-IR patients with active RA treated with UPA 15mg or 30mg monotherapy daily for 12 or 14weeks, respectively, reported rapid and clinically meaningful improvements in PtGA, pain, physical function, fatigue, morning stiffness, HRQOL and work productivity compared with MTX,” Strand and colleagues wrote. “UPA monotherapy offers an effective second-line treatment option for patients with RA who have an inadequate response to MTX.”
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