FRI0480 Tocilizumab mono-therapy for polymyalgia rheumatica ~ results of 104-week treatment of a prospective, single-centre, open trial
Authors: K. Amano, K. Chino, Y. Okada, A. Shibata, S. Saito, T. Kurasawa, A. Okuyama, H. Takei, R. Sakai, T. Kondo
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Polymyalgia rheumatic (PMR) is a chronic inflammatory rheumatic disease in the elderly people. Glucocorticoid (GC) is still definitely a mainstay for the treatment of PMR, but long-term GC therapy is a major risk factor of osteoporotic fractures, diabetes, hyperlipidemia, cardio-cerebral vascular events, glaucoma, etc. So GC-free treatment strategies for PMR are awaited for some PMR patients with these comorbidities. IL-6 is involved in the pathogenesis of PMR and several case reports have already shown the efficacy of tocilizumab (TCZ), anti-IL-6 receptor antibody, in PMR patients<sup>1,2)</sup> and there is a report of TCZ mono-therapy as the first-line therapy in PMR<sup>3)</sup>. <h3>Objectives</h3> To assess the efficacy and safety of TCZ mono-therapy for PMR <h3>Methods</h3> Thirteen PMR patients (male 3, female 10) who had been diagnosed by 2012 ACR/EULAR classification criteria from Jan 2013 to Feb 2015 were enrolled in our single-centre, prospective study (IRB application No. 638, UMIN No. 000008812) after obtaining the written informed consent. TCZ (8 mg/kg) was administered biweekly for the first 8 weeks (5 infusions) and every 4 weeks thereafter for 40 weeks (total 15 infusions). ESR, CRP, patient's global health assessed by visual analogue scale (VAS), PMR activity score<sup>4)</sup> were evaluated every 4 week prospectively. Primary endpoint was remission rate at week 52. Remission was defined as PMR activity score less than 1.5<sup>4)</sup>. Patients were followed up for another one year without any treatment and flare rate was assessed at week 104. <h3>Results</h3> Baseline patients' characteristics revealed various kinds of comorbidities in 11 patients; hypertension in 7, hyperlipidemia in 5, diabetes mellitus in 3, osteoporotic vertebral fractures in 2, history of angina pectoris in 1, history of brain infarction in 1, history of hematemesis due to NSAID ulcer in 1 and glaucoma in one patient. Nine patients could complete this 104 week trial and all 9 patients could achieve remission at week 52 and 8 of 9 patients fulfilled remission criteria at week 104. Two patients discontinued TCZ because of no response at week 6 (No.1) and week 16 (No. 8) respectively. One patient (No.2), who were in clinical remission of PMR, dropped out from this study due to pemphigoid at week 50 and received GC therapy. Patient No. 12 abandoned TCZ at week 12 because of lung infiltrates although she was treated successfully with TCZ mono-therapy, and she had been in remission without any treatment until week 104. The other 3 patients could obtain remission with GC therapy at week 52. There were no serious adverse events during 104 week treatment period. <h3>Conclusions</h3> TCZ mono-therapy was effective in most (9 out of 13) PMR patients although response was not so rapid as compared to GC. TCZ mono-therapy may be a good alternative therapy instead of GC for elderly patients with various comorbidities. <h3>References</h3> [1] Unizony S, et al.: Arthritis Care Res2012;64(11):1720–1729. [2] Macchioni P, et al.: Semin Arthritis Rheum2013;43(1):113–118. [3] Devauchelle-Pensec V, et al.: Ann Rheum Dis2016;75(8):1506–1510. [4] Leeb BF, et al.: Arthritis Rheum2007;57(5):810–815. <h3>Disclosure of Interest</h3> K. Amano Grant/research support from: Chugai Pharmaceutical Co. Ltd., Speakers bureau: Chugai, Daiichi-Sankyo, Pfizer Japan, Tanabe-Mitsubishi, K. Chino: None declared, Y. Okada: None declared, A. Shibata: None declared, S. Saito: None declared, T. Kurasawa: None declared, A. Okuyama: None declared, H. Takei: None declared, R. Sakai: None declared, T. Kondo: None declared