Effectiveness and safety of tocilizumab in achieving clinical and functional remission, and sustaining efficacy in biologics-naive patients with rheumatoid arthritis: The FIRST Bio study

Abstract

Objective: To evaluate effectiveness and safety of tocilizumab (TCZ) in biologic-naive Japanese patients with rheumatoid arthritis (RA) in real-world settings, and to analyze the relationship between disease duration and clinical outcomes. Methods: The FIRST Bio study was a postmarketing surveillance study of intravenous TCZ in biologics-naive patients who had a prior inadequate response or were intolerant to 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Effectiveness, safety, and concomitant csDMARD administration were assessed. Results: Of the 839 patients analyzed, 72.3% completed 52 weeks of treatment. The Clinical Disease Activity Index (CDAI) remission rate at week 52 was 36.8%. Contributing factors for CDAI remission were younger age, early disease stage, and no comorbidities. Health Assessment Questionnaire Disability Index 0.5 was achieved in 65.1% of patients, and was significantly associated with disease duration. Discontinuation of concomitant methotrexate (MTX) and glucocorticoids (GCs) was possible in 19.3% and 34.1% of patients, respectively, without decreasing remission rate. The incidence (events/100 patient-years) of serious adverse events was 18.09, the most common being infection. Conclusion: These data validate the importance of TCZ treatment in the early stages of RA in biologic-naive patients to achieve increased effectiveness. The safety profile of TCZ was reconfirmed. Furthermore, TCZ therapy may allow discontinuation of concomitant MTX and GCs without affecting remission.

Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies

“…In addition, patients in the present analysis with any change in corticosteroid dose had an overall reduction in daily dose from baseline to month 6 [mean (SD) change,  − 2.2 (9.0) mg]. Corticosteroid-sparing effects of TCZ have similarly been observed in other real-world studies of TCZ use in routine practice conducted in Japan [9], France [25, 26], Australia [27], Germany [28], and the USA [29]. Together, these findings show that both TCZ monotherapy and combination therapy reduce the need for corticosteroids in patients with RA.…”

“…This pattern of decreased concomitant csDMARD use may be an indirect measure of the effectiveness of TCZ. The observational FIRST Bio study of biologic-naive patients with RA initiating TCZ also reported a reduction in both the proportion of patients receiving concomitant MTX and the MTX dose at month 6 [9]. …”

“…TCZ is approved worldwide for the treatment of RA in patients who have had an inadequate response to one or more csDMARDs and, in the European Union, in patients who are MTX naive [7, 8]. TCZ has demonstrated efficacy in patients with an inadequate response to csDMARDs or TNFis [9–12] and in patients who are MTX naive [13, 14], and it has been shown to be effective when administered as monotherapy or in combination with MTX [15–18]. …”

Targeted Therapy and Infections in Rheumatic Diseases

“…При 24-месячном проспективном наблюдении нарастания риска СКИ не отмечено [43]. Тоцилизумаб В ходе РКИ и продолженных открытых исследований частота СКИ, развивавшихся у больных РА при лечении то-цилизумабом (ТЦЗ), колебалась в пределах 4,4-9,0 на 100 па-циенто-лет [44][45][46][47][48][49][50][51] и была аналогичной таковой у больных, получавших иФНОα. При увеличении суточной дозы с 4 до 8 мг/кг вероятность развития СКИ повышалась в 2,33 раза [52].…”

Biological Therapy and Infection in Rheumatoid Arthritis Patients: Modern Aspects

“…В ходе РКИ и продолженных открытых исследований частота СКИ, развивавшихся при лечении тоцилизумабом (ТЦЗ), колебалась в пределах 4,4-9,0 на 100 пациенто-лет [29][30][31][32][33][34][35][36] и была аналогичной таковой у больных, получав-ших иФНО-α. При увеличении суточной дозы с 4 до 8 мг/кг вероятность развития СКИ повышалась в 2,33 раза [37].…”