Volume 8, Issue 3, May 2020, Page: 125-132
Multicenter, Open-Label, Long-term Extension to Describe the Safety of Tocilizumab in Patients with Early, Moderate to Severe Rheumatoid Arthritis
Irena Kafedziska, Public Health Institution University Clinic of Rheumatology, Medical Faculty, University “Ss. Cyril and Methodius”, Skopje, Republic of North Macedonia
Snezhana Mishevska-Perchinkova, Public Health Institution University Clinic of Rheumatology, Medical Faculty, University “Ss. Cyril and Methodius”, Skopje, Republic of North Macedonia
Dubravka Antova, Public Health Institution University Clinic of Rheumatology, Medical Faculty, University “Ss. Cyril and Methodius”, Skopje, Republic of North Macedonia
Mimoza Kotevska Nikolova, Public Health Institution University Clinic of Rheumatology, Medical Faculty, University “Ss. Cyril and Methodius”, Skopje, Republic of North Macedonia
Anzhelika Stojanovska, Public Health Institution University Clinic of Rheumatology, Medical Faculty, University “Ss. Cyril and Methodius”, Skopje, Republic of North Macedonia
Filip Guchev, Public Health Institution University Clinic of Rheumatology, Medical Faculty, University “Ss. Cyril and Methodius”, Skopje, Republic of North Macedonia
Received: May 2, 2019;       Accepted: Jan. 27, 2020;       Published: May 28, 2020
DOI: 10.11648/j.ajim.20200803.16      View  63      Downloads  39
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.
Keywords
Rheumatoid Arthritis, Tocilizumab, Safety, Adverse Effects, Efficiency
To cite this article
Irena Kafedziska, Snezhana Mishevska-Perchinkova, Dubravka Antova, Mimoza Kotevska Nikolova, Anzhelika Stojanovska, Filip Guchev, Multicenter, Open-Label, Long-term Extension to Describe the Safety of Tocilizumab in Patients with Early, Moderate to Severe Rheumatoid Arthritis, American Journal of Internal Medicine. Vol. 8, No. 3, 2020, pp. 125-132. doi: 10.11648/j.ajim.20200803.16
Copyright
Copyright © 2020 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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