Background Sarilumab is a human mAb blocking the IL-6Rα, approved for adult patients with moderately to severely active RA. The incidence of Type 2 diabetes is increased in patients with RA, and elevated IL-6 may be an independent risk factor.
Objectives We conducted a post hoc analysis into the effect of sarilumab treatment on glycosylated hemoglobin (HbA1c) levels.
Methods TARGET (NCT01709578) was a 24-week study of sarilumab 150/200 mg q2w vs placebo (all +csDMARD) in TNFi-inadequate response/intolerant (IR/INT) patients. MONARCH (NCT02332590) was a 24-week monotherapy study of sarilumab 200 mg q2w vs adalimumab 40 mg q2w in MTX-IR/INT, bDMARD-naïve patients. There were 78/546 (14.3%) and 28/369 (7.6%) diabetic patients per ADA criteria (baseline fasting glucose ≥7 mmol/L or baseline HbA1c ≥6.5%) in TARGET and MONARCH, respectively.
Results In patients with RA and diabetes, the decrease in HbA1c at Week 24 was greater in sarilumab-treated groups than placebo (TARGET; in combination with csDMARDs) or adalimumab (MONARCH; monotherapy) groups (Figure). There was no interaction between change in HbA1c and corticosteroid use nor were changes in HbA1c correlated with changes in CRP, DAS28-CRP, or hemoglobin level. Among sarilumab-treated patients, those with baseline IL-6 >37.5 pg/mL (>3× upper limit of normal) had greater reductions in HbA1c (least squares mean change -0.27) than those with baseline IL-6 levels ≤37.5 pg/mL (least squares mean change -0.11). Sarilumab safety profile was similar in diabetic vs non-diabetic patients with RA.
Conclusion Patients with RA and diabetes treated with sarilumab had greater improvements in HbA1c than those treated with adalimumab or placebo. With monotherapy, differences between sarilumab and adalimumab were more pronounced among patients with higher baseline serum IL-6 levels.
Acknowledgement Study funding and editorial support (Helen Johns, Adelphi) were provided by Sanofi and Regeneron Pharmaceuticals, Inc. These data have been submitted to the 2019 APLAR-ARA annual meeting.
Disclosure of Interests Mark C. Genovese Grant/research support from: Sanofi/Genzyme, Genentech/Roche, RPharm, Consultant for: Sanofi/Genzyme, Genentech/Roche, RPharm, Gerd Rüdiger Burmester Consultant for: Roche, Sanofi-Genzyme, Speakers bureau: Roche, Sanofi-Genzyme, Owen Hagino Shareholder of: Sanofi Genzyme, Employee of: Sanofi Genzyme, Hubert van Hoogstraten Shareholder of: Sanofi, Regeneron, Novartis, Grant/research support from: Zambon, Employee of: Sanofi, Erin Mangan Shareholder of: Regeneron, Pfizer, Employee of: Regeneron, Karthinathan Thangavelu Shareholder of: Sanofi, Employee of: Sanofi, Roy Fleischmann Grant/research support from: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celtrion, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer Inc, Sanofi-Aventis, UCB, Consultant for: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celtrion, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer Inc, Sanofi-Aventis, UCB, Thomas Mandrup-Poulsen Consultant for: Sanofi Genzyme, Speakers bureau: Sanofi
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