RESEARCH - Long-term safety and efficacy of Actemra (tocilizumab) in patients with RA: STREAM

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Published Online First: 19 November 2008. doi:10.1136/ard.2008.092866

ls of the Rheumatic Diseases 2009;68:1580-1584

Extended report

Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor

monoclonal antibody, in monotherapy, in patients with rheumatoid

arthritis (the STREAM study): evidence of safety and efficacy in a

5-year extension study

N Nishimoto1, N Miyasaka2, K Yamamoto3, S Kawai4, T Takeuchi5, J Azuma1

1 Osaka University, Osaka, Japan

2 Tokyo Medical and Dental University, Tokyo, Japan

3 University of Tokyo, Tokyo, Japan

4 Toho University Omori Medical Center, Tokyo, Japan

5 Saitama Medical Center/School, Saitama, Japan

Objectives: To evaluate the safety and efficacy of 5-year, long-term

tocilizumab monotherapy for patients with rheumatoid arthritis.

Methods: In an open-label, long-term extension trial following an

initial 3-month randomised phase II trial, 143 of the 163 patients who

participated in the initial blinded study received tocilizumab

monotherapy (8 mg/kg) every 4 weeks. Concomitant therapy with

non-steroidal anti-inflammatory drugs and/or oral prednisolone (10 mg

daily maximum) was permitted. All patients were evaluated with

American College of Rheumatology (ACR) improvement criteria, disease

activity score (DAS) in 28 joints, and the European League Against

Rheumatism response, as well as for safety issues.

Results: 143 patients were enrolled in the open-label, long-term

extension trial and 94 (66%) patients had completed 5 years as of

March 2007. 32 patients (22%) withdrew from the study due to adverse

events and one patient (0.7%) due to unsatisfactory response. 14

patients withdrew because of the patient’s request or other reasons.

The serious adverse event rate was 27.5 events per 100 patient-years,

with 5.7 serious infections per 100 patient-years, based on a total

tocilizumab exposure of 612 patient-years. Of the 88 patients

receiving corticosteroids at baseline, 78 (88.6%) were able to

decrease their corticosteroid dose and 28 (31.8%) discontinued

corticosteroids. At 5 years, 79/94 (84.0%), 65/94 (69.1%) and 41/94

(43.6%) of the patients achieved ACR20, ACR50, and ACR70 improvement

criteria, respectively. Remission defined as DAS28 less than 2.6 was

achieved in 52/94 (55.3%) of the patients.

Conclusion: In this 5-year extension study, tocilizumab demonstrated

sustained long-term efficacy and a generally good safety profile.

http://ard.bmj.com/cgi/content/abstract/68/10/1580?etoc

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