Effectiveness of Tocilizumab for Rheumatoid Arthritis
Effectiveness of Tocilizumab for Rheumatoid Arthritis
Objectives. To evaluate the effectiveness and safety of tocilizumab in RA patients in clinical practice.
Methods. We observed 232 consecutive RA patients who began tocilizumab in three rheumatology centres in Japan for 52 weeks. Clinical, radiographic and functional status and safety were evaluated.
Results. Mean age of the 232 patients was 59.1 years, mean duration of disease was 12.4 years and average DAS using the 28-joint count (DAS-28) was 5.6. Although 62.8% of the patients had been treated previously with anti-TNF biologics, clinical remission at Week 52 was achieved in 43.7%, radiographic non-progression in 62.8% and functional remission in 26.4%. Retention rate at Week 52 was 71.1%, and the same for those with or without previous anti-TNF treatment. Adverse drug reactions leading to tocilizumab discontinuation were observed in 15.5% of patients, the most frequent adverse drug reaction being pneumonia in eight cases. On multivariate logistic regression analysis, DAS-28, HAQ-disability index (HAQ-DI), concomitant MTX and concomitant glucocorticoids (GCs) were predictive variables for clinical remission at Week 52 of tocilizumab treatment. In particular, HAQ-DI was found to be a predictive variable for remission of all three types—clinical, radiographic and functional—at Week 52 of tocilizumab treatment.
Conclusions. In daily clinical practice, tocilizumab exhibited excellent effectiveness in established RA patients, some of whom had failed to respond to previous anti-TNF treatment. Although further detailed safety findings are required, this study provides valuable real-world findings on the management of RA with tocilizumab.
Pro-inflammatory cytokines play a fundamental role in the inflammatory processes leading to destructive arthritis in patients with RA. Biological agents against pro-inflammatory cytokines such as TNF-α have dramatically changed the management of patients with RA. It is now recommended to treat RA patients to achieve clinical remission by early and tight control of disease activity with intensive medication. Recent clinical trials have shown that treatment with anti-TNF biologics in combination with MTX in early RA can lead to clinical remission in ~50% of patients; however, the remaining half of the patients are either those not able to achieve clinical remission or discontinued anti-TNF biologics and switched to other medications. A new biological agent, tocilizumab, targeting the IL-6 receptor has recently been approved for use in patients with RA in more than 40 countries around the world, including Japan, drawing attention to the effectiveness and safety of tocilizumab in clinical practice. Generally, randomized clinical trials (RCTs) are considered the gold standard for evaluation of the efficacy of newly developed agents. However, RCTs are artificial and may not reflect efficacy and safety in the real rheumatology world.
While we have reported the effectiveness of tocilizumab at Week 24, there is no report that evaluates all efficacy with regard to clinical remission, structural remission and functional remission of tocilizumab comprehensively under daily clinical practice. Hence we undertook the Retrospective Actemra Investigation for Optimal Needs of RA Patients (REACTION 52-week study) to confirm the efficacy and safety of tocilizumab in daily clinical practice.
Abstract and Introduction
Abstract
Objectives. To evaluate the effectiveness and safety of tocilizumab in RA patients in clinical practice.
Methods. We observed 232 consecutive RA patients who began tocilizumab in three rheumatology centres in Japan for 52 weeks. Clinical, radiographic and functional status and safety were evaluated.
Results. Mean age of the 232 patients was 59.1 years, mean duration of disease was 12.4 years and average DAS using the 28-joint count (DAS-28) was 5.6. Although 62.8% of the patients had been treated previously with anti-TNF biologics, clinical remission at Week 52 was achieved in 43.7%, radiographic non-progression in 62.8% and functional remission in 26.4%. Retention rate at Week 52 was 71.1%, and the same for those with or without previous anti-TNF treatment. Adverse drug reactions leading to tocilizumab discontinuation were observed in 15.5% of patients, the most frequent adverse drug reaction being pneumonia in eight cases. On multivariate logistic regression analysis, DAS-28, HAQ-disability index (HAQ-DI), concomitant MTX and concomitant glucocorticoids (GCs) were predictive variables for clinical remission at Week 52 of tocilizumab treatment. In particular, HAQ-DI was found to be a predictive variable for remission of all three types—clinical, radiographic and functional—at Week 52 of tocilizumab treatment.
Conclusions. In daily clinical practice, tocilizumab exhibited excellent effectiveness in established RA patients, some of whom had failed to respond to previous anti-TNF treatment. Although further detailed safety findings are required, this study provides valuable real-world findings on the management of RA with tocilizumab.
Introduction
Pro-inflammatory cytokines play a fundamental role in the inflammatory processes leading to destructive arthritis in patients with RA. Biological agents against pro-inflammatory cytokines such as TNF-α have dramatically changed the management of patients with RA. It is now recommended to treat RA patients to achieve clinical remission by early and tight control of disease activity with intensive medication. Recent clinical trials have shown that treatment with anti-TNF biologics in combination with MTX in early RA can lead to clinical remission in ~50% of patients; however, the remaining half of the patients are either those not able to achieve clinical remission or discontinued anti-TNF biologics and switched to other medications. A new biological agent, tocilizumab, targeting the IL-6 receptor has recently been approved for use in patients with RA in more than 40 countries around the world, including Japan, drawing attention to the effectiveness and safety of tocilizumab in clinical practice. Generally, randomized clinical trials (RCTs) are considered the gold standard for evaluation of the efficacy of newly developed agents. However, RCTs are artificial and may not reflect efficacy and safety in the real rheumatology world.
While we have reported the effectiveness of tocilizumab at Week 24, there is no report that evaluates all efficacy with regard to clinical remission, structural remission and functional remission of tocilizumab comprehensively under daily clinical practice. Hence we undertook the Retrospective Actemra Investigation for Optimal Needs of RA Patients (REACTION 52-week study) to confirm the efficacy and safety of tocilizumab in daily clinical practice.
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