Multicenter, Open-Label, Long-term Extension to Describe the Safety of Tocilizumab in Patients with Early, Moderate to Severe Rheumatoid Arthritis

Irena Kafedziska,Mimoza Kotevska Nikolova,Filip Guchev,Snezhana Mishevska-Perchinkova,Dubravka Antova,Anzhelika Stojanovska

doi:10.11648/j.ajim.20200803.16

Abstract

Introduction: Biologic DMARDs (Disease Modifying Anti Rheumatic Drugs) have shown to be effective in the treatment of rheumatoid arthritis (RA) resistant to the use of synthetic DMARDs. The primary goal of this study was to assess the long-term safety of the use of tocilizumab in patients with early rheumatoid arthritis, moderate to severe disease activity. The secondary goal was to assess the efficiency of tocilizumab in achieving and maintaining clinical remission of the disease. Methods: ML28133 is a long-term, extended study of 13 patients with rheumatoid arthritis treated with tocilizumab. Two patients were male (15.4%), 11 (84.61%) female. The average age of patients was 53.27+/-10.68. Patients received 8 mg/kg tocilizumab i.v. every four weeks, 104 weeks overall. Safety was assessed following side effects, blood tests, physical examination and vital signs. Efficiency was assessed by achieving and maintaining clinical remission according to DAS28 (Disease Activity Score 28), global assessment of disease activity, VAS score and HAQ-DI (Health Activity Score) questionnaire. Results: Incidence of side effects was 76.92%. Infections were of special interest and were most common (15.3%). Four patients had serious adverse events, three of which associated with tocilizumab, and therapy was stopped. In 11 (84.6%) of the 13 treated patients clinical remission was achieved at times. At the end of the study, 8 out of 9 patients were in remission. Conclusion: The results have shown significant therapeutic effect of tocilizumab even in the most severe forms of the disease, which gives hope for its use as a monotherapy.

Highlights

Biologic diseasemodifying antirheumatic drug (DMARD) (Disease Modifying Anti Rheumatic Drugs) have shown to be effective in the treatment of rheumatoid arthritis (RA) resistant to the use of synthetic DMARDs
The primary goal of this study was to evaluate the safety of tocilizumab used for a long time period, in patients who had completed the basic WA 19926 study and who had benefited from the treatment
The safety of tocilizumab was assessed with a special accent on following potential infections, serious adverse effects and events of special significance associated with the study medication

Summary

Introduction

Biologic DMARDs (Disease Modifying Anti Rheumatic Drugs) have shown to be effective in the treatment of rheumatoid arthritis (RA) resistant to the use of synthetic DMARDs. Biologic DMARDs (Disease Modifying Anti Rheumatic Drugs) attack the molecules in the cascade of the inflammatory response and interfere with it They calm the inflammation, the synovial hyperplasy, degeneration and degradation of the cartilage and the destruction of the subchondral bone and joints. They have been shown to be very effective in the treatment of rheumatoid arthritis, in the early forms of the disease, as well as in patients with developed disease and severe disease activity resistant to the standard treatment with synthetic DMARDs

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Discussion

Conclusion