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Randomized Controlled Trial
. 2021 Mar;80(3):349-355.
doi: 10.1136/annrheumdis-2020-218547. Epub 2020 Oct 14.

Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial

Pascal Richette  1   2 , Augustin Latourte #  3   2 , Jérémie Sellam #  4 , Daniel Wendling  5 , Muriel Piperno  6 , Philippe Goupille  7 , Yves-Marie Pers  8 , Florent Eymard  9   10 , Sébastien Ottaviani  11 , Paul Ornetti  12   13 , René-Marc Flipo  14 , Bruno Fautrel  15   16 , Olivier Peyr  17 , Jean Pierre Bertola  18 , Eric Vicaut  19 , Xavier Chevalier  9   10
Affiliations
Randomized Controlled Trial

Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial

Pascal Richette et al. Ann Rheum Dis. 2021 Mar.

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.

Keywords: cytokines; osteoarthritis; therapeutics.

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Conflict of interest statement

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.

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