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.
| INTRODUC TI ONPolymyalgia rheumatica (PMR) is a systemic inflammatory disease of unknown etiology. It mainly affects elderly people and rarely arises in people younger than 50 years old. Typical clinical features of PMR include proximal myalgia (particularly in the shoulder girdles), morning stiffness of the trunk, and elevated erythrocyte sedimentation rate (ESR) and serum C-reactive protein (CRP) levels. 1,2 Glucocorticoids (GC) remain the mainstay therapy for PMR 2,3 because they produce dramatic responses in most patients. However, approximately half of patients with PMR experience relapse after tapering of the GC dose. 2,4 Moreover, long-term GC therapy can produce substantial adverse events, such as osteoporotic compression fractures of the spine, diabetes, infections and cardio-cerebral vascular events. 2,5,6 Abstract Objectives: Polymyalgia rheumatica (PMR) is a systemic inflammatory disease in the elderly of unknown etiology. While glucocorticoids are the mainstay of treatment for PMR, various glucocorticoid-related adverse events are common. Recently, several studies have reported the efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, for PMR treatment in addition to an accompanying reduction, or even tapering-off, of glucocorticoids in some cases. The objective of this study was to elucidate the efficacy of TCZ monotherapy in the absence of glucocorticoids for PMR. Method:We conducted a 2-year, prospective, single-center, open-label pilot study of TCZ monotherapy in patients with PMR. TCZ (8 mg/kg) was administered at fortnightly intervals for the first 2 months and monthly over the next 10 months.Subsequently, patients were observed for another year without any treatment. The primary endpoints were the remission rates at weeks 12 and 52, and the secondary endpoints were the relapse rate and safety over the total 104 weeks.Results: Thirteen patients were included in this study. Four of these patients achieved remission at week 12 (remission rate 31%). Four patients withdrew from the study due to adverse events (n = 2) and inefficacy (n = 2). At week 52, all 9 patients who had completed the first year achieved remission. Eight patients completed the drug-free second year, with 7 maintaining remission.Conclusions: TCZ monotherapy is well tolerated and can lead to remission in most patients with PMR in the absence of glucocorticoids. K E Y W O R D Sglucocorticoid, interleukin-6, monotherapy, polymyalgia rheumatica, tocilizumab agents. We used 15 infusions of TCZ. However, if fewer TCZ infusions are sufficient to control PMR and TCZ treatment could be ceased, then these cost problems would be negated. Therefore, the optimal number of infusions of TCZ required to control PMR activity must be determined in the future. In addition, as TCZ monotherapy is expected to reduce adverse events related to GCs, such as osteoporosis, diabetes, dyslipidemia, and so on, the additional costs associated with the treatment of these adverse events will be reduced.Several limitations of our study warran...
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