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THU0576 Tocilizumab Mono-Therapy for Polymyalgia Rheumatica ∼ A Single-Center, Open, Single-Arm Trial
  1. K. Chino,
  2. A. Shibata,
  3. A. Okuyama,
  4. T. Kondo,
  5. J. Kikuchi,
  6. R. Sakai,
  7. H. Takei,
  8. K. Amano
  1. Rheumatology and clinical immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan

Abstract

Background Polymyalgia rheumatica (PMR) is a chronic inflammatory rheumatic disease that mainly affects the elderly. Corticosteroids (CSs) are a definite mainstay for the treatment of PMR; however, their use is associated with severe, serious clinical complications, such as osteoporotic fractures, diabetes, hyperlipidemia, cardio-cerebral vascular events, and glaucoma. Therefore, CS-free treatment strategies may be necessary for some patients with PMR. Interleukin-6 (IL-6) may be involved in the pathogenesis of PMR; furthermore, some case reports have already shown the efficacy of tocilizumab (TCZ), an anti-IL-6 receptor antibody, in the treatment of patients with PMR who had been intolerant or refractory to glucocorticoids [1, 2, 3].

Objectives To assess the efficacy and safety of TCZ monotherapy for PMR

Methods Thirteen PMR patients (3 males, 10 females) diagnosed by the 2012 ACR/EULAR classification criteria between Jan 2013 and Feb 2015 were enrolled after obtaining a written informed consent. TCZ (8 mg/kg) was administered biweekly for the first 2 months (5 infusions) and every 4 weeks for subsequent 24 weeks. ESR, CRP, visual analog scale (VAS) assessment of the patient's global health, and PMR activity score were prospectively measured every 4 weeks and were evaluated at week 24 and 52. Remission was defined as a PMR activity score less than 1.5 as proposed by Leeb [4].

Results Baseline patient characteristics revealed various comorbidities in 11 of the patients; hypertension in seven, hyperlipidemia in five, diabetes mellitus in three, osteoporotic vertebral fractures in two, history of angina pectoris in one, history of brain infarction in one, history of hematemesis due to NSAID ulcer in one, and glaucoma in one patient. At week 24, nine patients achieved low disease activity as per the PMR activity score criteria, including three in remission. Two patients discontinued TCZ because of no response: one at week 6 and the other at week 16. Two patients discontinued TCZ due to adverse events [Editor 1]; pulmonary infiltrate at week 8, pemphigoid at week 50. The nine remaining patients achieved remission at week 52. There were no serious adverse events [Editor 2] except for pemphigoid during the 52-week treatment period.

Conclusions TCZ monotherapy was effective in most (nine out of 13 [Editor 1]) PMR patients, although the response was not as rapid as that to CSs. TCZ monotherapy may be a good alternative therapy to CSs for the elderly with various comorbidities.

  1. Unizony S, et al.: Arthritis Care Res 2012; 64(11):1720–1729

  2. Macchioni P, et al.: Aemin Arthritis Rheum 2013; 43(1): 113–118

  3. Toussirot E, et al.: J Rheumatol 2016 43(1): 249–251

  4. Leeb BF, et al.: Arthritis Rheum 2007; 57(5): 810–815

Disclosure of Interest K. Chino: None declared, A. Shibata: None declared, A. Okuyama: None declared, T. Kondo: None declared, J. Kikuchi: None declared, R. Sakai: None declared, H. Takei: None declared, K. Amano Grant/research support from: Chugai Pharmaceutical Co. Ltd.

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