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.
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Handling editor Josef S Smolen
AL and JS contributed equally.
Correction notice This article has been corrected since it published Online First. The title has been corrected.
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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