A post hoc analysis presented at CCR West found sarilumab outperformed adalimumab and placebo in HbA1c improvement in rheumatoid arthritis patients with diabetes.
Results of the study, which compared treatment of patients with rheumatoid arthritis and diabetes with sarilumab, adalimumab, and placebo therapies, were presented at the Clinical Congress of Rheumatology (CCR) West 2019 annual meeting in San Diego, CA.
In an effort to assess the effects of sarilumab on HbA1c, investigators conducted a post hoc analysis of 2, 24-week trials. The 2 trials included in the analysis were the TARGET (NCT01709578) trial and the MONARCH (NCT02332590) trial.
The TARGET trial was a study examining sarilumab—in 150/200 mg doses every two weeks— against placebo in patients who were intolerant or had an indequate response to anti-TNF treatment. Monarch was a monotherapy trial examining sarilumab 200 mg every 2 weeks compared with adalimumab 40 mg every 2 weeks in patients who were intolerant or had an inadequate response to methotrexate and were biologic disease-modifying antirheumatic drug naive.
TARGET involved 546 patients, of which 67 (12.3%) had diabetes. MONARCH included 369 patients, of which 26 (7%) had diabetes. Investigators noted diabetes was defined as a medical history of diabetes or concomitant use of antidiabetic treatment.
At 24 weeks, investigators noted differences in least-squares mean change from baseline in HbA1c between the three groups. Mean change from was with sarilumab 150/200 mg was -0.24%/-0.44% compared to +0.23% with placebo in TARGET. In MONARCH, investigators noted mean least-squares change of -0.28% with sarilumab compared to +0.15% with adalimumab monotherapies.
Patients with baseline IL-6 greater than 37.5 pg/mL treated with sarilumab had greater reductions in HbA1c then those with baseline IL-6 equal to or less than 37.5 pg/mL (least-squares mean change -0.27 versus -0.13).
Investigators pointed out there was no observed interaction between HbA1c and baseline glucocorticoid use. Additionally, changes in HbA1c did not correlated with changes in C-reactive protein, Disease Activity Score 28-joint count C-reactive protein, or hemoglobin.
Investigators suggested results of the study had multiple clinical implications. Those implications included patients with rheumatoid arthritis and diabetes saw greater improvement in HbA1c with sarilumab than with adalimumab or placebo and changes in HbA1c were not impacted by baseline glucocorticoid use.
“Patients with RA and diabetes treated with sarilumab had greater improvements in HbA1c than with adalimumab or placebo,” investigators wrote. “With monotherapy, differences between sarilumab and adalimumab were more pronounced among patients with higher baseline IL-6 level.”
This study, “Effect of Sarilumab on Glycosylated Hemoglobin in Patients with Rheumatoid Arthritis and Diabetes,” was presented at CCR West.