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Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy

Smolen, Josef S, Weinblatt, Michael E, Sheng, Shihong, Zhuang, Yanli, Hsu, Benjamin·2014·Annals of the Rheumatic Diseases
DOI 10.1136/annrheumdis-2013-205137PMC PMC4145446
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Figure 1 Patient disposition in (A) Part A and (B) Part B. Adverse events (AEs) leading to study agent discontinuation before week 12 were worsening of rheumatoid arthritis (placebo), cellulitis staphylococcal and pneumonia (sirukumab) in Part A; and included bacterial arthritis (placebo and sirukumab), fibrosarcoma (sirukumab), and serum sickness (sirukumab) in Part B.
Figure 1 Patient disposition in (A) Part A and (B) Part B. Adverse events (AEs) leading to study agent discontinuation before week 12 were worsening of rheumatoid arthritis (placebo), cellulitis staphylococcal and pneumonia (sirukumab) in Part A; and included bacterial arthritis (placebo and sirukumab), fibrosarcoma (sirukumab), and serum sickness (sirukumab) in Part B.CC BY-NC · PubMed Central
Figure 2 Proportions of patients with American College of Rheumatology 50 (ACR50) response (A, C) and mean changes from baseline in DAS28-C-reactive protein (CRP) (B, D), clinical disease activity index (CDAI) score (E, G), and simplified disease activity index (SDAI) score (F, H) in Parts A and B. Data from one of the study sites that participated in Part A were excluded from all efficacy analyses due to questionable data integrity. At week 12 in Part A, patients randomised to placebo crossed over to sirukumab 100 mg every 2 weeks, and patients randomised to sirukumab crossed over to placebo through week 22. At week 12 in Part B, patients randomised to placebo crossed over to sirukumab 100 mg every 2 weeks through week 24.
Figure 2 Proportions of patients with American College of Rheumatology 50 (ACR50) response (A, C) and mean changes from baseline in DAS28-C-reactive protein (CRP) (B, D), clinical disease activity index (CDAI) score (E, G), and simplified disease activity index (SDAI) score (F, H) in Parts A and B. Data from one of the study sites that participated in Part A were excluded from all efficacy analyses due to questionable data integrity. At week 12 in Part A, patients randomised to placebo crossed over to sirukumab 100 mg every 2 weeks, and patients randomised to sirukumab crossed over to placebo through week 22. At week 12 in Part B, patients randomised to placebo crossed over to sirukumab 100 mg every 2 weeks through week 24.CC BY-NC · PubMed Central
Figure 3 Mean (SD) serum sirukumab concentration versus time after multiple subcutaneous administrations of sirukumab in (A) Part A and (B) Part B and mean per cent change from baseline in serum concentrations of C-reactive protein (CRP) in (C) Part A and (D) Part B. Data from one of the study sites that participated in Part A were excluded from all pharmacokinetics and pharmacodynamics analyses due to questionable data integrity. Serum sirukumab concentrations were plotted starting on day 2 (Part A) and day 5 (Part B).
Figure 3 Mean (SD) serum sirukumab concentration versus time after multiple subcutaneous administrations of sirukumab in (A) Part A and (B) Part B and mean per cent change from baseline in serum concentrations of C-reactive protein (CRP) in (C) Part A and (D) Part B. Data from one of the study sites that participated in Part A were excluded from all pharmacokinetics and pharmacodynamics analyses due to questionable data integrity. Serum sirukumab concentrations were plotted starting on day 2 (Part A) and day 5 (Part B).CC BY-NC · PubMed Central

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Research works printed but not linked: 21

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Metadata

Authors
Smolen, J. S., Weinblatt, M. E., Sheng, S., Zhuang, Y., & Hsu, B.
Venue
Annals of the Rheumatic Diseases
Publisher
Elsevier BV
Published
2014-09
Volume
73
Issue
9
Pages
1616-1625
ISSN
0003-4967
DOI
10.1136/annrheumdis-2013-205137
PMC
PMC4145446
Cited by
139
References
0
Language
en
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CoChat. (2026). Citation check: Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. https://app.cochat.ai/papers/10.1136/annrheumdis-2013-205137
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Smolen, J. S., Weinblatt, M. E., Sheng, S., Zhuang, Y., & Hsu, B. (2014). Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2013-205137