Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study.

Abstract

OBJECTIVE:

To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA).

METHODS:

Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks.

RESULTS:

The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy.

CONCLUSION:

TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

• Authors: Atsushi Ogata, Koichi Amano, Hiroaki Dobashi, Masayuki Inoo, Tomonori Ishii, Tsuyoshi Kasama, Shinichi Kawai, Atsushi Kawakami, Tatsuya Koike, Hisaaki Miyahara, Toshiaki Miyamoto, Yasuhiko Munakata, Akira Murasawa, Norihiro Nishimoto, Noriyoshi Ogawa, Tomohiro Ojima, Hajime Sano, Kenrin Shi, Eisuke Shono, Eiichi Suematsu, Hiroki Takahashi, Yoshiya Tanaka, Hiroshi Tsukamoto, Akira Nomura, MUSASHI Study Investigators
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 42 Issue 5 Pg. 799-809 (May 2015) ISSN: 0315-162X [Print] Canada
• PMID: 25834203 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents
• tocilizumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Antirheumatic Agents (adverse effects, therapeutic use)
• Arthritis, Rheumatoid (drug therapy)
• Female
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• Treatment Outcome