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(Ethic)Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial
  1. Pascal Richette1,2,
  2. Augustin Latourte1,2,
  3. Jérémie Sellam3,
  4. Daniel Wendling4,
  5. Muriel Piperno5,
  6. Philippe Goupille6,
  7. Yves-Marie Pers7,
  8. florent Eymard8,9,
  9. Sébastien Ottaviani10,
  10. Paul Ornetti11,12,
  11. René-Marc Flipo13,
  12. Bruno Fautrel14,15,
  13. Olivier Peyr16,
  14. Jean Pierre Bertola17,
  15. Eric Vicaut18,
  16. Xavier Chevalier8,9
  1. 1APHP, Hôpital Lariboisière, Service de Rhumatologie, Paris, France
  2. 2Université de Paris, Inserm, UMR-S 1132, Bioscar, Paris, France
  3. 3Rheumatology, INSERM UMRS_938, Sorbonnes Université UPMC Univ Paris 06, St-Antoine Hospital, DHU i2B, Paris, France
  4. 4Rheumatology, CHU J Minjoz, Besancon, France
  5. 5Rheumatology, University Claude Bernard, Lyon, France
  6. 6Rheumatology, Trousseau University Hospital, Tours, France
  7. 7Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France
  8. 8Department of Rheumatology, APHP Henri Mondor Hospital, Créteil, France
  9. 9Universite Paris-Est Creteil Val de Marne, Creteil, Île-de-France, France
  10. 10Rheumatology, Hospital Bichat—Claude-Bernard, Paris, Île-de-France, France
  11. 11Rheumatology, Burgundy Franche-Comté University, Dijon, France
  12. 12Dijon University Hospital, Dijon, France
  13. 13Service de Rhumatologie, CHU Roger Salengro, Université de Lille, Lille, France
  14. 14Rheumatology, Assistance Publique - Hopitaux de Paris, Paris, France
  15. 15GRC08 - IPLESP, UPMC Faculte de Medecine, Paris, France
  16. 16Service de Rhumatologie, Hopital Lariboisiere Centre Viggo Petersen, Paris, Île-de-France, France
  17. 17Medical Affair, Chugai Pharma France SAS, Paris La Defense, France
  18. 18Unité de recherche clinique, Groupe hospitalier Lariboisiere Fernand-Widal, Paris, Île-de-France, France
  1. Correspondence to Professor Pascal Richette, service de rhumatologie, Hôpital Lariboisière, Paris, Île-de-France, France; pascal.richette{at}aphp.fr

Abstract

Objective To evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis.

Methods This was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0–100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients’ and physicians’ global assessment and function scores.

Results Of 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was −7.9 (SD 19.4) and −9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group.

Conclusion Tocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.

  • osteoarthritis
  • cytokines
  • therapeutics

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Footnotes

  • Handling editor Josef S Smolen

  • Twitter @A_Latourte

  • AL and JS contributed equally.

  • Collaborators Thomas Bardin; Hang-Korng Ea; Martine Cohen-Solal; Luminita Neculaita; Jean-Jacques Portal, Julien Champey; Beatrice Banneville; Rosanna Ferreira.

  • Contributors PR, XC and EV designed the study. PR, AL, JS, DW, MP, PG, Y-MP, FE, SO, PO, R-MF, OP and XC collected the data. PR, XC and EV analysed the data. PR, AL, JS, DW, MP, PG, Y-MP, FE, SO, PO, R-MF, BF, JPB and XC interpreted the data and wrote the manuscript.

  • Funding This is an academic study sponsored by the Assistance Publique-Hôpitaux de Paris and partly funded by Roche-Chugai (RC) which provided the tocilizumab. RC was not involved in the design, implementation and statistical analysis, which were performed independent of the firm.

  • Competing interests PR reports personal fees from Roche-Chugai, Expanscience, Pierre Fabre, Pfizer, Novartis, Janssen, Abbvie and Labhra. AL received fees from Pfizer. JS reports personal fees from Roche-Chugai, Abbvie, Fresenius Kabi, Merck Sharp and Dohme, Pfizer, Novartis, Janssen, Bristol Myers Squibb, Sanofi and Lilly. DW reports personal fees from AbbVie, BMS, MSD, Pfizer, Roche Chugai, Amgen, Nordic Pharma, UCB, Novartis, Janssen, Celgene, Hospira, Lilly, Sandoz, Grunenthal. MP received fees from Abbvie, Novartis, Biogen, Lilly, Medac, UCB, BMS, SANDOZ, Pfizer, Chugai. PG received research grants, consultation fees, or speaker honoraria from AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Janssen, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB. Y-MP reports consultancy fees from Novartis and Pfizer outside the submitted work. FE reports personal fees from RegenLab outside the submitted work. SO received fees from: Roche Chugai, MSD, Abbvie, Lilly, Novartis. PO reports personal fees and non-financial support from Roche-Chugai. RMF received fees from Abbvie, BMS, Janssen, MSD, Nordic pharma, Novartis, Pfizer, Roche-Chugai, Sanofi. BF has received grants or research support from AbbVie, Lilly, MSD, Pfizer; and consultancy fees from AbbVie, Biogen, BMS, Celgene, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, Sanofi-Aventis, SOBI, UCB. JPB is employed by Roche Chugai. XC received fees from IBSA, Pfizer, Dielen and Labrha.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Obtained.

  • Ethics approval The study was approved by the ethics committee (Ile de France, no. P-120206) and all participants provided informed consent.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Additional information (protocols and statistical analysis plan) are available upon request to the corresponding author (PR).

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