Strand V, et al. - Authors reported the impacts of sarilumab vs adalimumab on patient-reported outcomes (PROs) of patients with rheumatoid arthritis. Compared to adalimumab monotherapy greater improvements across multiple PROs were seen with sarilumab monotherapy in parallel with the clinical efficacy profile previously reported.

Methods

• Experts randomized the patients with active RA intolerant of, or inadequate responders to, methotrexate to sarilumab 200 mg plus placebo every 2 weeks (q2w; n=184) or adalimumab 40 mg plus placebo q2w (n=185).
• They permitted the dose escalation to weekly administration of adalimumab or matching placebo at week 16.
• Patient global assessment of disease activity (PtGA), pain and morning stiffness visual analogue scales (VASs), Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), Rheumatoid Arthritis Impact of Disease (RAID), and rheumatoid arthritis-specific Work Productivity Survey (WPS-RA) PROs that were assessed at baseline and weeks 12 and 24 were included.
• They analyzed the between-group differences in least-squares mean (LSM) changes from baseline.
• For PROs in a predefined hierarchy p < 0.05 was considered significant.
• Nominal p values are provided for PROs not in the hierarchy.
• They assessed the proportions of patients reporting improvements greater than or equal to the minimal clinically important difference (MCID) and achieving normative values.

Results

• As per data, at week 24, sarilumab treatment resulted in significantly greater LSM changes from baseline than adalimumab monotherapy in HAQ-DI (p < 0.005), PtGA (p < 0.001), pain VAS (p < 0.001), and SF-36 Physical Component Summary (PCS) (p < 0.001).
• Results demonstrated that for sarilumab greater LSM changes were reported than for adalimumab in RAID (nominalp < 0.001), morning stiffness VAS (nominal p < 0.05), and WPS-RA (nominal p < 0.005).
• Data suggested that in FACIT-F and SF-36 Mental Component Summary (MCS) between-group differences were not significant.
• Researchers noted that more patients reported improvements greater than or equal to the MCID in HAQ-DI (nominal p < 0.01), RAID (nominal p < 0.01), SF-36 PCS (nominal p < 0.005), and morning stiffness (nominal p < 0.05), as well as greater than or equal to the normative values in HAQ-DI (p < 0.05), with sarilumab vs adalimumab.