Abstract
BackgroundSarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex. In the MOBILITY phase III randomized controlled trial (RCT), sarilumab + methotrexate (MTX) treatment resulted in clinical improvements at 24 weeks that were maintained at 52 weeks in adults with rheumatoid arthritis (RA), who have inadequate response to MTX (MTX-IR). These analyses indicate the effects of sarilumab + MTX versus placebo on patient-reported outcomes (PROs) in this RCT.MethodsPatients (n = 1197) were randomized to receive placebo, sarilumab 150 or 200 mg subcutaneously + MTX every 2 weeks for 52 weeks; after 16 weeks, patients without ≥20 % improvement from baseline in swollen or tender joint counts on two consecutive assessments were offered open-label treatment. PROs included patient global assessment of disease activity (PtGA), pain, health assessment questionnaire disability index (HAQ-DI), Short Form-36 Health Survey (SF-36), and functional assessment of chronic illness therapy-fatigue (FACIT-F). Changes from baseline at weeks 24 and 52 were analyzed using a mixed model for repeated measures. Post hoc analyses included percentages of patients reporting improvements equal to or greater than minimal clinically important differences (MCID) and normative values in the FACIT-F and SF-36. Pearson correlation between observed PRO scores and clinical measures of disease activity was tested at week 24.ResultsBoth doses of sarilumab + MTX vs placebo + MTX resulted in improvement from baseline by week 24 in PtGA, pain, HAQ-DI, SF-36 and FACIT-F scores (p < 0.0001) that was clinically meaningful, and persisted until week 52. In post hoc analyses, the percentages of patients with improvement equal to or greater than the MCID across all PROs were greater with sarilumab than placebo (p < 0.05), with differences ranging from 11.6 to 26.2 %, as were those reporting equal to or greater than normative scores.ConclusionsIn this RCT in patients with MTX-IR RA, sarilumab + MTX resulted in sustained improvement in PROs that were clinically meaningful, greater than placebo + MTX, and complement the previously reported clinical efficacy and safety of sarilumab.Trial registrationClinicalTrials.gov. NCT01061736. February 2, 2010
Highlights
Sarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex
Changes from baseline least squares mean (LSM) improvements from baseline at week 24 in the patient global assessment of disease activity (PtGA), pain, and health assessment questionnaire disability index (HAQ-DI) scores were greater with sarilumab 150 mg and 200 mg than placebo (p < 0.0001) and were maintained at week 52 (Table 2)
The functional assessment of chronic illness therapy-fatigue (FACIT-F) demonstrated improvement at week 24 with sarilumab 150 mg and 200 mg that was significantly greater than placebo and was maintained through week 52 (p < 0.0001 for both doses at both time points) (Table 2)
Summary
Sarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex. In the MOBILITY phase III randomized controlled trial (RCT), sarilumab + methotrexate (MTX) treatment resulted in clinical improvements at 24 weeks that were maintained at 52 weeks in adults with rheumatoid arthritis (RA), who have inadequate response to MTX (MTX-IR) These analyses indicate the effects of sarilumab + MTX versus placebo on patient-reported outcomes (PROs) in this RCT. Crucial to the evaluation of a new therapeutic agent is the use of patient-reported outcomes (PROs) to comprehensively define treatment benefit as recommended by current international consensus [1,2,3] This manuscript reports PRO data from the 52-week phase III MOBILITY RCT of sarilumab in combination with methotrexate (MTX) in patients with RA, who have inadequate response to MTX (MTX-IR) Current analyses evaluated the impact of sarilumab on PROs, and correlation between these and changes in disease activity
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