title: Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study.
abstract: BACKGROUND
  Glucocorticoids are the cornerstone treatment of polymyalgia rheumatica (PMR) but induce adverse events.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of first-line tocilizumab in PMR.
  
  
  METHODS
  In a prospective open-label study (ClinicalTrials.gov: NCT01713842), 20 glucocorticoid-free patients fulfilling Chuang's PMR criteria, with symptom onset within the last 12 months and a PMR activity score (PMR-AS) >10, each received three tocilizumab infusions at 4-week intervals, without glucocorticoids, followed by oral prednisone from weeks 12 to 24 (0.15 mg/kg if PMR-AS ≤10 and 0.30 mg/kg otherwise). The primary end point was the proportion of patients with PMR-AS≤10 at week 12.
  
  
  RESULTS
  Baseline median PMR-AS was 36.6 (IQR 30.4-43.8). At week 12, all patients had PMR-AS≤10 and received the low prednisone dosage. Median PMR-AS at weeks 12 and 24 was 4.5 (3.2-6.8) and 0.95 (IQR 0.4-2), respectively (p<0.001 vs baseline for both time points). No patient required rescue treatment. Positron emission tomography-CT showed significant improvements. The most common adverse events were transient neutropenia (n=3) and leucopenia (n=5); in one patient, the second tocilizumab infusion was omitted due to leucopenia.
  
  
  CONCLUSIONS
  Tocilizumab monotherapy is effective in recent-onset PMR. Randomised controlled trials are warranted.
  
  
  BACKGROUND
  NCT01713842.
authors.affiliation: Rheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Devauchelle-Pensec
authors.affiliation: Rheumatology Department, Hôtel Dieu University Hospital, Nantes, France.
authors.forename: Jean Marie
authors.initials: JM
authors.lastname: Berthelot
authors.affiliation: Rheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
authors.forename: Divi
authors.initials: D
authors.lastname: Cornec
authors.affiliation: EA 2216, ERI 29, Brest University, Brest, France.
authors.forename: Yves
authors.identifier: http://orcid.org/0000-0001-5098-5002
authors.initials: Y
authors.lastname: Renaudineau
authors.affiliation: Rheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Marhadour
authors.affiliation: Rheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Jousse-Joulin
authors.affiliation: Nuclear Medicine Department, Morvan University Hospital, Brest, France.
authors.forename: Solène
authors.initials: S
authors.lastname: Querellou
authors.affiliation: Radiology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France.
authors.forename: Florent
authors.initials: F
authors.lastname: Garrigues
authors.affiliation: Rheumatology Department, Fort de France, Martinique, France.
authors.forename: Michel
authors.initials: M
authors.lastname: De Bandt
authors.affiliation: Clinical Investigation Centre[CIC] 1412, Institut National de la Santé et de la Recherche Médicale[INSERM], Brest, France.
authors.forename: Maelenn
authors.initials: M
authors.lastname: Gouillou
authors.affiliation: Rheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Saraux
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011111:Polymyalgia Rheumatica / Q000000981:diagnostic imaging / Q000188:drug therapy*; D000072078:Positron Emission Tomography Computed Tomography; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D005938:Glucocorticoids; C502936:tocilizumab; D011241:Prednisone
keywords: DMARDs (biologic); Disease Activity; Magnetic Resonance Imaging; Polymyalgia Rheumatica; Treatment