Hans Bröll1*, Raimund Lunzer2, Thomas Nothnagl3, Barbara Bauer4 and Burkhard F Leeb5
1Department of Rheumatology, Rheumatism Center Vienna-Oberlaa, Austria
2Department of Rheumatology, Hospital of the Brothers of Mercy Vienna, Austria
3Department of Rheumatology, State Hospital of Stockerau, Austria
4Roche Austria GmbH, Austria
5Private Practice, Austria
Tocilizumab (TCZ) has variously been approved in combination with Methotrexate for the treatment of Rheumatoid Arthritis (RA) in adults. The objectives of this Non-Interventional Study (NIS) were to assess the efficacy and safety of TCZ in routine clinical use. Clinical response to TCZ was evaluated by collecting Disease Activity Score 28 (DAS28) and other efficacy parameters. The number and type of Adverse Events (AEs) and concomitant medication were documented. The median treatment duration was 52 weeks. The efficacy and safety analyses included 590 patients, 97.8% of whom had been pretreated with disease-modifying anti-rheumatic drugs. DAS28 scores were available for 484 patients, of whom 67.98% experienced disease remission and 83.06% low disease activity at any time during treatment. AEs were reported for 21.02% of the patients, with 10% serious events. The results confirm that TCZ is efficacious and well tolerated in routine use for the treatment of RA. As the results of this NIS are in line with existing data, a reevaluation of the risk-benefit balance of TCZ for the treatment of RA does not seem necessary.
RoActemra; Tocilizumab; Rheumatoid arthritis; Non-interventional study; DAS28
Bröll H, Lunzer R, Nothnagl T, Bauer B, Leeb BF. The Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis: An Austrian NonInterventional Study. Am J Arthritis. 2018;2(1):1012.