Tocilizumab monotherapy for polymyalgia rheumatica: A prospective, single‐center, open‐label study

Abstract

| 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...

Monitoring and long-term management of giant cell arteritis and polymyalgia rheumatica

“…The role of anti-IL-6 treatment for PMR has been evaluated in several small, open-label studies with a duration of 24 to 52 weeks 25,26,[127][128][129] . In aggregate, these studies with a total of 53 patients suggest that anti-IL-6 therapy might be associated with lower glucocorticoid doses and lower rates of relapse than glucocorticoids alone, although symptom relief seemed to occur sooner in glucocorticoid-treated patients.…”

“…In aggregate, these studies with a total of 53 patients suggest that anti-IL-6 therapy might be associated with lower glucocorticoid doses and lower rates of relapse than glucocorticoids alone, although symptom relief seemed to occur sooner in glucocorticoid-treated patients. Three of these studies assessed tocilizumab monotherapy 26,128,129 . In one of the studies 129 , 9 out of 13 (69%) patients achieved remission with tocilizumab monotherapy at 1 year.…”

Treatment Patterns, Disease Burden, and Outcomes in Patients with Giant Cell Arteritis and Polymyalgia Rheumatica: A Real-World, Electronic Health Record-Based Study of Patients in Clinical Practice

“…prednisone groups [35,36]. Results from prospective, open-label trials suggest that tocilizumab may be effective for the treatment of PMR [37][38][39]. GCA giant cell arteritis, PMR polymyalgia rheumatica, SD standard deviation…”

A Spi̇ral of Cumulati̇ve Problems: Gerontorheumatology

“…In elderly, comorbidities and issues related drug safety may affect treat to target considerations. Low-to-medium dose glucocorticoids are the cornerstone of treatment, methotrexate provides modest benefits and there are promising reports regarding tocilizumab monotherapy (23,24). On the other hand, glucocorticoid-based regimens cause much of the morbidity related to polymyalgia rheumatica in elderly (21).…”