title: Brief Report: A Prospective Open-Label Phase IIa Trial of Tocilizumab in the Treatment of Polymyalgia Rheumatica.
abstract: Interleukin-6 (IL-6) is a pivotal cytokine in the pathogenesis of polymyalgia rheumatica (PMR), yet the efficacy of IL-6 blockade with tocilizumab (TCZ) for the treatment of PMR is unknown. The aim of this study was to assess the efficacy and safety of TCZ in newly diagnosed PMR.
  
  
  
  In a single-center open-label study, patients with newly diagnosed PMR who had been treated with glucocorticoids (GCs) for <1 month were treated monthly with intravenous (IV) TCZ 8 mg/kg for 1 year, with a rapid tapering of GCs according to standardized protocol. The primary end point was the proportion of patients in relapse-free remission without GC treatment at 6 months. Secondary outcome measures included duration of GC use and cumulative GC dose. Patients were followed up for 15 months.
  
  
  
  Ten patients were enrolled in the study. One patient withdrew after 2 months, leaving 9 patients in whom the primary end point was assessed. The primary end point of relapse-free remission without GC treatment at 6 months was achieved by all 9 of these patients. All patients who received TCZ treatment were able to discontinue GCs within 4 months of study entry. The cumulative mean ± SD prednisone dose was 1,085 ± 301 mg and the total duration of GC exposure was 3.9 ± 0.9 months. Remission persisted without relapse, in all 9 patients, throughout the entire 15-month study.
  
  
  
  Our findings suggest that TCZ may be an effective, safe, and well-tolerated treatment for newly diagnosed patients with PMR, with a robust steroid-sparing effect.
authors.affiliation: Hospital for Special Surgery, New York, New York. lally1@hss.edu.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Lally
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Lindsy
authors.initials: L
authors.lastname: Forbess
authors.affiliation: Hospital for Special Surgery, New York, New York.
authors.forename: Christopher
authors.initials: C
authors.lastname: Hatzis
authors.affiliation: Hospital for Special Surgery, New York, New York.
authors.forename: Robert
authors.initials: R
authors.lastname: Spiera
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000069340:Deprescriptions; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D006937:Hypercholesterolemia / Q000139:chemically induced; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011111:Polymyalgia Rheumatica / Q000188:drug therapy*; D011241:Prednisone / Q000627:therapeutic use; D011446:Prospective Studies; D012074:Remission Induction; D012141:Respiratory Tract Infections / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D007155:Immunologic Factors; C502936:tocilizumab; D011241:Prednisone