학술논문
Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study
Document Type
Academic Journal
Author
Genovese, Mark C.; Fleischmann, Roy; Kivitz, Alan J.; Rell-Bakalarska, Maria; Martincova, Renata; Fiore, Stefano; Rohane, Patricia; van Hoogstraten, Hubert; Garg, Anju; Fan, Chunpeng; van Adelsberg, Janet; Weinstein, Steven P.; Graham, Neil M. H.; Stahl, Neil; Yancopoulos, George D.; Huizinga, Tom W. J.; van der Heijde, Désirée
Source
Arthritis & Rheumatology. Jun 01, 2015 67(6):1424-1437
Subject
Language
English
ISSN
2326-5191
Abstract
OBJECTIVE.: METHODS.: RESULTS.: Baseline characteristics were similar among the groups. For all 3 co–primary end points, the sarilumab 150 mg and 200 mg groups demonstrated statistically significant improvements as compared with the placebo group (ACR20 response rate at week 24, 58.0%, 66.4%, and 33.4%, respectively [P < 0.0001]; least squares mean change in HAQ DI at week 16, −0.53, −0.55, and −0.29, respectively [P < 0.0001]; and mean change in SHS at week 52, 0.90, 0.25, and 2.78, respectively [P < 0.0001]). The most common treatment-emergent adverse event was infection. In the sarilumab 150 mg, sarilumab 200 mg, and placebo groups, the incidence of serious infections was 2.6%, 4.0%, and 2.3%, respectively. Elevations in alanine aminotransferase levels >3-fold the upper limit of normal occurred in 9.5%, 8.0%, and 2.1% of patients, respectively; in 24 patients, this led to discontinuation of treatment. Elevated total cholesterol levels were observed in 36.8%, 43.0%, and 18.3% of patients, respectively. In patients receiving 150 mg and 200 mg sarilumab, neutrophil counts of 0.5 to <1.0 × 10/liter were observed in 5.1% and 7.8% of patients, respectively, while neutrophil counts of <0.5 × 10/liter were observed in 0.9% and 0.7% of patients, respectively; none of the patients receiving placebo experienced changes in neutrophil counts. CONCLUSION.