Objective To evaluate the safety and efficacy of tocilizumab in clinical practice in patients with rheumatoid arthritis (RA) with inadequate responses (IR) to disease-modifying antirheumatic drugs (DMARDs) or both DMARDs and tumour necrosis factor α inhibitors (TNFis).
Methods Patients—categorised as TNFi-naive, TNFi-previous (washout) or TNFi-recent (no washout) —received open-label tocilizumab (8 mg/kg) every 4 weeks ± DMARDs for 24 weeks. Adverse events (AEs) and treatment discontinuations were monitored. Efficacy end points included American College of Rheumatology (ACR) responses, 28-joint disease activity score (DAS28) and European League Against Rheumatism responses.
Results Overall, 1681 (976 TNF-naive, 298 TNFi-previous and 407 TNFi-recent) patients were treated; 5.1% discontinued treatment because of AEs. The AE rate was numerically higher in TNFi-recent (652.6/100 patient-years (PY)) and TNFi-previous (653.6/100PY) than in TNFi-naive (551.1/100PY) patients. Serious AE rates were 18.0/100PY, 28.0/100PY and 18.6/100PY; serious infection rates were 6.0/100PY, 6.8/100PY and 4.2/100PY, respectively. At week 4, 36.5% of patients achieved ACR20 response and 14.9% DAS28 remission (<2.6); at week 24, 66.9%, 46.6%, 26.4% and 56.8% achieved ACR20/ACR50/ACR70 responses and DAS28 remission, respectively. Overall, 61.6% (TNFi-naive), 48.5% (TNFi-previous) and 50.4% (TNFi-recent) patients achieved DAS28 remission.
Conclusions In patients with RA who were DMARD-IR/TNFi-IR, tocilizumab ± DMARDs provided rapid and sustained efficacy without unexpected safety concerns.
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Funding Funding for manuscript preparation was provided by F Hoffmann-La Roche Ltd.
Competing interests VPB has received consulting fees from Amgen, Pfizer, BMS, Roche, UCB; her institution has received grants from Amgen, Pfizer, BMS, UCB, Roche. AJKO has received consulting and expert testimony fees for expert opinion, honoraria for lectures, fees for the development of educational presentations and aids and travel expenses to attend conferences. JA-G has received consulting fees from Roche, BMS, UCB, Pfizer/Wyeth; lecture/speakers bureau fees from Roche, BMS, UCB, Pfizer/Wyeth, MSD/Schering-Plough, Abbott; travel expenses from Roche; and grants to his institution from Roche. KP has received board member fees from Roche, Pfizer, Amgen, UCB; consulting fees from Roche, MSD, Pfizer, UCB, BMS; and lecturer/speaker fees from Roche, MSD, Pfizer, UCB, BMS, Abbott. JARI has received travel expenses from Abbott, Roche; and grants from MSD, Roche. WG has received board member, consulting, and lecture/speaker fees from Roche, BMS, Pfizer, MSD, Abbott, UCB; and consulting fees/honorarium paid to his institution from Roche. WB has received board membership, consulting/honoraria, lecture/speaker fees; and has received grants paid to his institution. MTN has received consulting fees from Abbott, Roche, MSD, BMS, UCB, Wyeth, Sobi; speaker/lecture fees from Abbott, Roche, Pfizer; travel expenses from Roche, MSD; and grants from Roche, Abbott, Pfizer to his institution. AK has received board membership, consulting, lecture/speaker fees and travel expenses from Roche/Chugai. CB has received consulting fees from Roche Global Medical Affairs. AS was an employee of F Hoffmann-La Roche Ltd, Basel, Switzerland. JS has received board membership and consulting fees from Roche, MSD, Abbott, Pfizer, UCB.
Ethics approval Protocol approval by institutional review boards, ethics committees and/or regulatory authorities and patients' written informed consent were obtained in accordance with the Declaration of Helsinki, and good clinical practice was followed.
Provenance and peer review Not commissioned; externally peer reviewed.