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Objective  The development of biomarkers to guide treatment decisions is a major research focus in rheumatoid arthritis ( RA ). Patients with  RA  have elevated interleukin‐6 ( IL ‐6) levels; however, the utility of  IL ‐6 as a predictor of treatment response is unclear. This study was undertaken to investigate, by post hoc analysis, whether baseline  IL ‐6 levels are predictive of sarilumab treatment responses in 2 phase  III  studies.    Methods  Serum  IL ‐6 concentrations were measured in patients with  RA  prior to receiving sarilumab 200 mg (n = 148) or adalimumab 40 mg (n = 152) every 2 weeks (in the  MONARCH  trial; ClinicalTrials.gov identifier:  NCT 02332590) or sarilumab 150 mg, sarilumab 200 mg, or placebo every 2 weeks plus methotrexate ( MTX ) (n = 401, n = 396, and n = 397, respectively) (in the  MOBILITY  trial; ClinicalTrials.gov identifier:  NCT 01061736). Efficacy and patient‐reported outcomes were compared between and within groups according to  IL ‐6 tertile using linear and logistic regression.    Results  In  MONARCH , patients with high baseline  IL ‐6 levels (all ≥3 times the upper limit of normal; n = 100) had higher disease activity at baseline than those with low  IL ‐6 levels (n = 100). The magnitude of clinical improvement over 24 weeks with sarilumab versus adalimumab was greater in patients with high compared to those with low baseline  IL ‐6 levels. In  MOBILITY , compared to patients with low  IL ‐6 levels (n = 397), patients with high  IL ‐6 levels (n = 398) had higher disease activity and joint damage at baseline, were more likely to have joint progression, and had less clinical improvement over 52 weeks’ treatment with placebo plus  MTX  compared to sarilumab 150 mg or 200 mg plus  MTX . Baseline  IL ‐6 and C‐reactive protein levels were both predictive of outcomes. Safety profiles were similar between defined  IL ‐6 tertiles.    Conclusion   IL ‐6 may be a prognostic marker of disease progression and severity, and patients with high  IL ‐6 levels may be likely to benefit from sarilumab compared to adalimumab or  MTX . Prospective validation is warranted to confirm the results of these post hoc analyses.

arthritis and rheumatology

Association of High Serum Interleukin‐6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis