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Sarilumab and Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors

Fleischmann, Roy, van Adelsberg, Janet, Lin, Yong, Castelar‐Pinheiro, Geraldo da Rocha, Brzezicki, Jan, Hrycaj, Pawel, Graham, Neil M. H., van Hoogstraten, Hubert, Bauer, Deborah, Burmester, Gerd R.·2017·Arthritis & Rheumatology
DOI 10.1002/art.39944PMC PMC6207906
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Abstract

Objective: To evaluate the efficacy and safety of sarilumab plus conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) in patients with active moderate‐to‐severe rheumatoid arthritis (RA) who had an inadequate response or intolerance to anti–tumor necrosis factor (anti‐TNF) therapy. Methods: Patients were randomly allocated to receive sarilumab 150 mg, sarilumab 200 mg, or placebo every 2 weeks for 24 weeks with background conventional synthetic DMARDs. The co‐primary end points were the proportion of patients achieving a response according to the American College of Rheumatology 20% criteria for improvement (ACR20) at week 24, and change from baseline in the Health Assessment Questionnaire disability index (HAQ DI) at week 12. Each sarilumab dose was evaluated against placebo; differences between the 2 sarilumab doses were not assessed. Results: The baseline characteristics of the treatment groups were similar. The ACR20 response rate at week 24 was significantly higher with sarilumab 150 mg and sarilumab 200 mg every 2 weeks compared with placebo (55.8%, 60.9%, and 33.7%, respectively; P < 0.0001). The mean change from baseline in the HAQ DI score at week 12 was significantly greater for sarilumab (least squares mean change: for 150 mg, −0.46 [ P = 0.0007]; for 200 mg, −0.47 [ P = 0.0004]) versus placebo (−0.26). Infections were the most frequently reported treatment‐emergent adverse events. Serious infections occurred in 1.1%, 0.6%, and 1.1% of patients receiving placebo, sarilumab 150 mg, and sarilumab 200 mg, respectively. Laboratory abnormalities included decreased absolute neutrophil count and increased transaminase levels in both sarilumab groups compared with placebo. In this study, reductions in the absolute neutrophil count were not associated with an increased incidence of infections or serious infections. Conclusion: Sarilumab 150 mg and sarilumab 200 mg every 2 weeks plus conventional synthetic DMARDs improved the signs and symptoms of RA and physical function in patients with an inadequate response or intolerance to anti‐TNF agents. Safety data were consistent with interleukin‐6 receptor blockade and the known safety profile of sarilumab.

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Figure 1 Patient disposition. a = Screen failures mainly resulted from failure to meet the inclusion criterion for disease severity (53%), for not having a high‐sensitivity C‐reactive protein level of ≥8 mg/liter, or because of tuberculosis (21%). b = A total of 5 patients (1 in the placebo group and 4 in the sarilumab 150 mg group) discontinued from the study because their laboratory values measured at baseline were abnormal and precluded them from study inclusion before treatment initiation. AE = adverse event; q2w = every 2 weeks.
Figure 1 Patient disposition. a = Screen failures mainly resulted from failure to meet the inclusion criterion for disease severity (53%), for not having a high‐sensitivity C‐reactive protein level of ≥8 mg/liter, or because of tuberculosis (21%). b = A total of 5 patients (1 in the placebo group and 4 in the sarilumab 150 mg group) discontinued from the study because their laboratory values measured at baseline were abnormal and precluded them from study inclusion before treatment initiation. AE = adverse event; q2w = every 2 weeks.CC BY-NC-ND · PubMed Central
Figure 2 Incidence of American College of Rheumatology 20% criteria for improvement (ACR20), ACR50, and ACR70 responses. A, Proportion of patients who had achieved ACR20, ACR50, and ACR70 responses at week 24. Values inside the bars are the response rates. B, Proportion of patients who had achieved ACR20, ACR50, and ACR70 responses over time. * = P < 0.0001 versus placebo plus conventional synthetic disease‐modifying antirheumatic drug(s) (csDMARD[s]); † = P = 0.0002 versus placebo plus csDMARD(s); ‡ = P = 0.0056 versus placebo plus csDMARD(s). q2w = every 2 weeks.
Figure 2 Incidence of American College of Rheumatology 20% criteria for improvement (ACR20), ACR50, and ACR70 responses. A, Proportion of patients who had achieved ACR20, ACR50, and ACR70 responses at week 24. Values inside the bars are the response rates. B, Proportion of patients who had achieved ACR20, ACR50, and ACR70 responses over time. * = P < 0.0001 versus placebo plus conventional synthetic disease‐modifying antirheumatic drug(s) (csDMARD[s]); † = P = 0.0002 versus placebo plus csDMARD(s); ‡ = P = 0.0056 versus placebo plus csDMARD(s). q2w = every 2 weeks.CC BY-NC-ND · PubMed Central
Figure 3 Mean change from baseline in Health Assessment Questionnaire disability index (HAQ DI) scores. A, Least squares mean (LSM) change from baseline in HAQ DI scores at week 12. B, LSM change from baseline in the HAQ DI over time according to treatment group. C, Proportion of patients who had achieved improvement in the HAQ DI of ≥0.22 units at week 24. D, Proportion of patients who had achieved improvement in the HAQ DI of ≥0.30 units at week 24. In C and D, values inside the bars are the response rates. * = P < 0.0001 versus placebo plus csDMARDs; † = P < 0.01 versus placebo plus csDMARDs; ‡ = P < 0.05 versus placebo plus csDMARDs. Dotted vertical line indicates the time point after which rescue was permitted. See Figure 2 for other definitions.
Figure 3 Mean change from baseline in Health Assessment Questionnaire disability index (HAQ DI) scores. A, Least squares mean (LSM) change from baseline in HAQ DI scores at week 12. B, LSM change from baseline in the HAQ DI over time according to treatment group. C, Proportion of patients who had achieved improvement in the HAQ DI of ≥0.22 units at week 24. D, Proportion of patients who had achieved improvement in the HAQ DI of ≥0.30 units at week 24. In C and D, values inside the bars are the response rates. * = P < 0.0001 versus placebo plus csDMARDs; † = P < 0.01 versus placebo plus csDMARDs; ‡ = P < 0.05 versus placebo plus csDMARDs. Dotted vertical line indicates the time point after which rescue was permitted. See Figure 2 for other definitions.CC BY-NC-ND · PubMed Central

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Metadata

Authors
Fleischmann, R., van Adelsberg, J., Lin, Y., Castelar‐Pinheiro, G. D. R., Brzezicki, J., Hrycaj, P., Graham, N. M. H., van Hoogstraten, H., Bauer, D., & Burmester, G. R.
Affiliations
  • Metroplex Clinical Research Center and University of Texas Southwestern Medical Center Dallas
  • Regeneron Pharmaceuticals Tarrytown New York
  • Sanofi Bridgewater New Jersey
  • Rio de Janeiro State University Rio de Janeiro Brazil
  • Centrum Kliniczno‐Badawcze Elblag Poland
  • Poznań University of Medical Sciences Poznań Poland
  • Charité University Medicine Free University, and Humboldt University, Berlin Germany
Venue
Arthritis & Rheumatology
Publisher
Wiley
Published
2017-01-28
Volume
69
Issue
2
Pages
277-290
ISSN
  • 2326-5191
  • 2326-5205
DOI
10.1002/art.39944
PMC
PMC6207906
Cited by
178
References
2
Language
en
Licence
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Funders
Sanofi and Regeneron Pharmaceuticals

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CoChat. (2026). Citation check: Sarilumab and Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors. https://app.cochat.ai/papers/10.1002/art.39944
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Fleischmann, R., van Adelsberg, J., Lin, Y., Castelar‐Pinheiro, G. D. R., Brzezicki, J., Hrycaj, P., Graham, N. M. H., van Hoogstraten, H., Bauer, D., & Burmester, G. R. (2017). Sarilumab and Nonbiologic Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors. Arthritis & Rheumatology. https://doi.org/10.1002/art.39944