Efficacy and safety of sirukumab in Japanese patients with moderate to severe rheumatoid arthritis inadequately controlled by disease modifying anti-rheumatic drugs: Subgroup analysis of a phase 3 study

Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Masayoshi Harigai, Toshikazu Nakano, Koshiro Akagi, Yoshifumi Ukyo, Benjamin Hsu

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objective: To evaluate the efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis (RA) uncontrolled by disease-modifying antirheumatic drugs. Methods: This subgroup analysis based on a double-blind, placebo-controlled, 52-week phase 3 study (SIRROUND-D) assessed American College of Rheumatology (ACR) 20 response at week 16 and van der Heijde-modified Sharp score (vdH-S) at week 52 (coprimary endpoints). Results: A total of 168 (Japanese)/1670 patients received sirukumab 50 mg/4 weeks (q4w, n = 58), 100 mg/every 2 weeks (q2w, n = 54), or placebo (n = 56) subcutaneously. Significantly more patients achieved ACR20 response at week 16 with sirukumab (50 mg q4w: 69.0%; 100mg q2w: 66.7%) vs. placebo (21.4%; p < .001). Median change from baseline in total vdH-S score at week 52 was significantly lower with sirukumab (50 mg q4w: 0.3, p = .024; 100 mg q2w: 0.0, p = .002) vs. placebo (1.3). Sirukumab consistently showed greater improvements in secondary endpoints at weeks 24 and 52. Nasopharyngitis, elevated liver enzymes, injection site erythema and upper respiratory tract infections were the common treatment-emergent adverse events (TEAEs). Incidences of TEAEs and serious AEs were consistent between sirukumab groups through week 52. Conclusion: Sirukumab showed clinically meaningful improvements consistent with significant improvements in the global study. No new safety signals were observed.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalModern Rheumatology
DOIs
Publication statusAccepted/In press - 2018 Feb 7

Fingerprint

Antirheumatic Agents
Rheumatoid Arthritis
Safety
Placebos
Nasopharyngitis
Erythema
sirukumab
Respiratory Tract Infections
Injections
Liver
Incidence
Enzymes
Therapeutics

Keywords

  • Disease-modifying anti-rheumatic drugs
  • interleukin-6
  • Japan
  • rheumatoid arthritis
  • sirukumab

ASJC Scopus subject areas

  • Rheumatology

Cite this

Efficacy and safety of sirukumab in Japanese patients with moderate to severe rheumatoid arthritis inadequately controlled by disease modifying anti-rheumatic drugs : Subgroup analysis of a phase 3 study. / Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Harigai, Masayoshi; Nakano, Toshikazu; Akagi, Koshiro; Ukyo, Yoshifumi; Hsu, Benjamin.

In: Modern Rheumatology, 07.02.2018, p. 1-9.

Research output: Contribution to journalArticle

@article{0295849a09834b89800275a017c3f783,
title = "Efficacy and safety of sirukumab in Japanese patients with moderate to severe rheumatoid arthritis inadequately controlled by disease modifying anti-rheumatic drugs: Subgroup analysis of a phase 3 study",
abstract = "Objective: To evaluate the efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis (RA) uncontrolled by disease-modifying antirheumatic drugs. Methods: This subgroup analysis based on a double-blind, placebo-controlled, 52-week phase 3 study (SIRROUND-D) assessed American College of Rheumatology (ACR) 20 response at week 16 and van der Heijde-modified Sharp score (vdH-S) at week 52 (coprimary endpoints). Results: A total of 168 (Japanese)/1670 patients received sirukumab 50 mg/4 weeks (q4w, n = 58), 100 mg/every 2 weeks (q2w, n = 54), or placebo (n = 56) subcutaneously. Significantly more patients achieved ACR20 response at week 16 with sirukumab (50 mg q4w: 69.0{\%}; 100mg q2w: 66.7{\%}) vs. placebo (21.4{\%}; p < .001). Median change from baseline in total vdH-S score at week 52 was significantly lower with sirukumab (50 mg q4w: 0.3, p = .024; 100 mg q2w: 0.0, p = .002) vs. placebo (1.3). Sirukumab consistently showed greater improvements in secondary endpoints at weeks 24 and 52. Nasopharyngitis, elevated liver enzymes, injection site erythema and upper respiratory tract infections were the common treatment-emergent adverse events (TEAEs). Incidences of TEAEs and serious AEs were consistent between sirukumab groups through week 52. Conclusion: Sirukumab showed clinically meaningful improvements consistent with significant improvements in the global study. No new safety signals were observed.",
keywords = "Disease-modifying anti-rheumatic drugs, interleukin-6, Japan, rheumatoid arthritis, sirukumab",
author = "Tsutomu Takeuchi and Yoshiya Tanaka and Hisashi Yamanaka and Masayoshi Harigai and Toshikazu Nakano and Koshiro Akagi and Yoshifumi Ukyo and Benjamin Hsu",
year = "2018",
month = "2",
day = "7",
doi = "10.1080/14397595.2018.1428929",
language = "English",
pages = "1--9",
journal = "Modern Rheumatology",
issn = "1439-7595",
publisher = "Springer Japan",

}

TY - JOUR

T1 - Efficacy and safety of sirukumab in Japanese patients with moderate to severe rheumatoid arthritis inadequately controlled by disease modifying anti-rheumatic drugs

T2 - Subgroup analysis of a phase 3 study

AU - Takeuchi, Tsutomu

AU - Tanaka, Yoshiya

AU - Yamanaka, Hisashi

AU - Harigai, Masayoshi

AU - Nakano, Toshikazu

AU - Akagi, Koshiro

AU - Ukyo, Yoshifumi

AU - Hsu, Benjamin

PY - 2018/2/7

Y1 - 2018/2/7

N2 - Objective: To evaluate the efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis (RA) uncontrolled by disease-modifying antirheumatic drugs. Methods: This subgroup analysis based on a double-blind, placebo-controlled, 52-week phase 3 study (SIRROUND-D) assessed American College of Rheumatology (ACR) 20 response at week 16 and van der Heijde-modified Sharp score (vdH-S) at week 52 (coprimary endpoints). Results: A total of 168 (Japanese)/1670 patients received sirukumab 50 mg/4 weeks (q4w, n = 58), 100 mg/every 2 weeks (q2w, n = 54), or placebo (n = 56) subcutaneously. Significantly more patients achieved ACR20 response at week 16 with sirukumab (50 mg q4w: 69.0%; 100mg q2w: 66.7%) vs. placebo (21.4%; p < .001). Median change from baseline in total vdH-S score at week 52 was significantly lower with sirukumab (50 mg q4w: 0.3, p = .024; 100 mg q2w: 0.0, p = .002) vs. placebo (1.3). Sirukumab consistently showed greater improvements in secondary endpoints at weeks 24 and 52. Nasopharyngitis, elevated liver enzymes, injection site erythema and upper respiratory tract infections were the common treatment-emergent adverse events (TEAEs). Incidences of TEAEs and serious AEs were consistent between sirukumab groups through week 52. Conclusion: Sirukumab showed clinically meaningful improvements consistent with significant improvements in the global study. No new safety signals were observed.

AB - Objective: To evaluate the efficacy and safety of sirukumab in Japanese patients with active rheumatoid arthritis (RA) uncontrolled by disease-modifying antirheumatic drugs. Methods: This subgroup analysis based on a double-blind, placebo-controlled, 52-week phase 3 study (SIRROUND-D) assessed American College of Rheumatology (ACR) 20 response at week 16 and van der Heijde-modified Sharp score (vdH-S) at week 52 (coprimary endpoints). Results: A total of 168 (Japanese)/1670 patients received sirukumab 50 mg/4 weeks (q4w, n = 58), 100 mg/every 2 weeks (q2w, n = 54), or placebo (n = 56) subcutaneously. Significantly more patients achieved ACR20 response at week 16 with sirukumab (50 mg q4w: 69.0%; 100mg q2w: 66.7%) vs. placebo (21.4%; p < .001). Median change from baseline in total vdH-S score at week 52 was significantly lower with sirukumab (50 mg q4w: 0.3, p = .024; 100 mg q2w: 0.0, p = .002) vs. placebo (1.3). Sirukumab consistently showed greater improvements in secondary endpoints at weeks 24 and 52. Nasopharyngitis, elevated liver enzymes, injection site erythema and upper respiratory tract infections were the common treatment-emergent adverse events (TEAEs). Incidences of TEAEs and serious AEs were consistent between sirukumab groups through week 52. Conclusion: Sirukumab showed clinically meaningful improvements consistent with significant improvements in the global study. No new safety signals were observed.

KW - Disease-modifying anti-rheumatic drugs

KW - interleukin-6

KW - Japan

KW - rheumatoid arthritis

KW - sirukumab

UR - http://www.scopus.com/inward/record.url?scp=85041522860&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85041522860&partnerID=8YFLogxK

U2 - 10.1080/14397595.2018.1428929

DO - 10.1080/14397595.2018.1428929

M3 - Article

C2 - 29336187

AN - SCOPUS:85041522860

SP - 1

EP - 9

JO - Modern Rheumatology

JF - Modern Rheumatology

SN - 1439-7595

ER -