Abstract

Objective: to evaluate the efficacy of tocilizumab (TCZ) versus tofacitinib (TOFA) in patients with severe and moderate rheumatoid arthritis (RA) who have not previously received methotrexate (MTX). Material and methods. A systematic search for studies dealing with the evaluation of the efficacy of TCZ and TOFA was made in accordance with the provisions of the instruction «Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)». Indirect comparison of two Function and ORAL Start randomized clinical trials was done, as described by Н.C. Buchera. The trials were comparable in their design and in the baseline characteristics of patients. The efficiency of pharmacotherapy for early RA was evaluated based on the ACR20/50/70 response rates in MTX-naive patients from three endpoints. Results. The indirect comparison of TOFA and TCZ (A MTX general control) after 52 weeks of treatment in MT-naive patients with severe and moderate RA indicated that the use of TOFA 5 mg twice daily and TCZ 8 mg/kg showed no difference in ACR20, ACR50, and ACR70 response rates. Nevertheless, there was a tendency to the greater efficiency of TOFA (5 mg twice daily) than that of TCZ (8 mg/kg). The indirect comparison of TOFA (10 mg twice daily) and TCZ (8 mg/kg) established that TCZ therapy was associated with the lower response rate for ACR50 (by 37%): the relative risk (RR) was 0.63; 95% confidence interval (CI), 0.44–0.90 and for ACR70 (by 51%): RR, 0.49; 95% CI, 0.29–0.83 as compared with TOFA therapy. Conclusion. The indirect comparisons confirmed that monotherapy with TOFA (10 mg twice daily) produced a more pronounced antiinflammatory effect than that with TCZ in MTX-naive patients with early severe and moderate RA of less than one year's duration. There were no statistically significant differences in ACR response rates between the TOFA (5 mg twice daily) and TCZ (8 mg/kg) groups.

Highlights

  • Comparison of several alternative uses of targeted antirheumatic drugs in monotherapy for early rheumatoid arthritis Shatalova O.V., Gorbatenko V.S

  • A systematic search for studies dealing with the evaluation of the efficacy of TCZ and TOFA was made in accordance with the provisions of the instruction «Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)»

  • The efficiency of pharmacotherapy for early rheumatoid arthritis (RA) was evaluated based on the ACR20/50/70 response rates in MTX-naive patients from three endpoints

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Summary

Непрямое сравнение

Если при публикации результатов РКИ в статье в качестве авторов. 107 – публикации на языке, отличном от английского 318 – публикации об исследованиях, которые проводились не на людях 334 – дублирующиеся ссылки 389 – публикации, посвященные обзорам, повторному анализу данных РКИ 381 – публикации, не относящиеся к проблеме эффективности ТЦЗ и ТОФА 14 – нерелевантная нозология 9 – нерелевантная конечная точка нии-производителя или автор получал персональные гранты от производителя препарата, то возникший конфликт интересов должен рассматриваться как дополнительный источник СО и по этому домену риск СО оценивается как высокий. В исследовании ТОФА ORAL Start в качестве соавторов публикации были указаны сот-. Оценка уровня риска СО в сравниваемых РКИ (0 – низкий риск, 1 – неопределенный, 2 – высокий), итоговые оценки риска (А, В, С) в соответствии с Кокрановскими критериями. Итоговые оценки приведены в табл. 1, уровень оценки был понижен до С, что подразумевает высокий риск СО в данных работах

Общая оценка
Findings
Непрямое сравнение эффективности ТЦЗ и ТОФА
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