Background/Purpose: Evaluation of response to RA therapy at 12 weeks after initiation is recommended in treatment guidelines. CRP response after 12 weeks of therapy may indicate favorable subsequent improvement in patient-reported outcomes (PROs). Here, we describe the association between CRP response to sarilumab at Week 12 and PRO improvements at Week 24, using data from 3 pivotal studies.

Methods: The analysis included patients with RA who took part in MOBILITY (NCT01061736), TARGET (NCT01709578), or MONARCH (NCT02332590) and were treated with sarilumab 200 mg every 2 weeks (q2w) or adalimumab 40 mg q2w (MONARCH only). Patients who achieved a CRP response at Week 12 (defined as serum concentration ≤3 mg/L) were evaluated for PROs at Week 24. Response for PROs was defined as an improvement from baseline in visual analog scale score of ≥10 mm for pain, sleep, and morning stiffness, and an improvement of ≥4 points for the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score. Odds ratios (ORs) and 95% confidence intervals (CIs) were generated for the likelihood of achieving PRO responses at Week 24, based on patients’ achievement of CRP response at Week 12.

Results: Data for pain and fatigue were available in all 3 trials, for morning stiffness in TARGET and MONARCH only, and for sleep in MOBILITY only. After 12 weeks of treatment with sarilumab 200 mg every 2 weeks, CRP ≤3 mg/L was attained in 74% (137/184), 78% (311/399), and 80% (148/184) of patients from TARGET, MOBILITY, and MONARCH, respectively; in MONARCH, treatment with adalimumab 40 mg q2w was associated with CRP response in 35% (64/185) of patients. Across all 3 trials and all 4 PROs assessed, attainment of CRP ≤3 mg/L at Week 12 was associated with a higher proportion of PRO responders at Week 24 (Figure). These data suggest higher odds of achieving Week 24 PRO response in sarilumab-treated patients who did versus those who did not attain CRP ≤3 mg/L at Week 12 (Table). In MONARCH, sarilumab-treated patients who attained CRP ≤3 mg/L at Week 12 had numerically higher odds of achieving Week 24 PRO response than their adalimumab-treated counterparts (Table).

Conclusion: This post hoc analysis suggests that, in patients with moderate to severe RA treated with sarilumab 200 mg q2w or adalimumab 40 mg q2w, attainment of a CRP level ≤3 mg/L at Week 12 could predict improvements in pain, sleep, morning stiffness, or fatigue at Week 24.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/association-between-changes-in-c-reactive-protein-at-week-12-and-patient-reported-outcomes-at-week-24-with-sarilumab-therapy-across-three-pivotal-phase-3-studies/