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Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study
  1. Valérie Devauchelle-Pensec1,2,
  2. Jean Marie Berthelot3,
  3. Divi Cornec1,2,
  4. Yves Renaudineau2,
  5. Thierry Marhadour1,
  6. Sandrine Jousse-Joulin1,2,
  7. Solène Querellou4,
  8. Florent Garrigues5,
  9. Michel De Bandt6,
  10. Maelenn Gouillou7,
  11. Alain Saraux1,2
  1. 1Rheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France
  2. 2EA 2216, ERI 29, Brest University, Brest, France
  3. 3Rheumatology Department, Hôtel Dieu University Hospital, Nantes, France
  4. 4Nuclear Medicine Department, Morvan University Hospital, Brest, France
  5. 5Radiology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France
  6. 6Rheumatology Department, Fort de France, Martinique, France
  7. 7Clinical Investigation Centre[CIC] 1412, Institut National de la Santé et de la Recherche Médicale[INSERM], Brest, France
  1. Correspondence to Professor Valerie Devauchelle, Rheumatology Unit, Hôpital de la Cavale Blanche, BP 824, Brest cedex F 29609, France; valerie.devauchelle-pensec{at}chu-brest.fr

Abstract

Background Glucocorticoids are the cornerstone treatment of polymyalgia rheumatica (PMR) but induce adverse events.

Objectives 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.

Trial registration number NCT01713842.

  • Polymyalgia Rheumatica
  • Treatment
  • Disease Activity
  • Magnetic Resonance Imaging
  • DMARDs (biologic)

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