Efficacy of Tocilizumab in Patients with Hand Osteoarthritis: Double Blind, Randomized, Placebo Controlled, Multicenter Trial

Pascal Richette¹, Augustin Latourte², Jeremie Sellam³, Daniel Wendling⁴, Muriel Piperno⁵, Philippe Goupille⁶, Yves-Marie Pers⁷, Florent Eymard⁸, Sebastien Ottaviani⁹, Paul Ornetti¹⁰, Rene-Marc Flipo¹¹, Bruno Fautrel¹², Jean-Pierre Bertola¹³, Eric Vicaut¹⁴ and Xavier Chevalier¹⁵, ¹Department of Rheumatology, Lariboisière Hospital, AP-HP Université de Paris, INSERM U1132, Paris, ²Department of Rheumatology, Lariboisière Hospital, AP-HP Université de Paris, INSERM U1132, Paris, France, ³AP-HP, Hôpital Saint-Antoine, Service de Rhumatologie, Centre de Recherche Saint-Antoine, INSERM UMR_S 938,Sorbonne Université, Paris, 75012, France, Paris, France, ⁴CHU Besançon, department of rheumatology, Besancon, France, ⁵Rheumatology Department, Lyon University Hospital, Lyon, France, ⁶CHU Tours, department of rheumatology, Tours, France, ⁷IRMB, University of Montpellier, Inserm U1183, University Hospital of Montpellier, Montpellier, France, ⁸APHP Henri Mondor Hospital, Creteil, France, ⁹Rheumatology Department, Bichat hospital, APHP, Paris, France, ¹⁰CHU Dijon, INSERM CAPS 1093, plateforme d’investigation technologique CIC1432, Dijon, France, ¹¹Lille University Hospital, Lille, France, ¹²Sorbonne University, INSERM, IPLES; Pitié-Salpêtrière Hospital, Paris, Ile-de-France, France, ¹³CHUGAI PHARMA FRANCE, Paris, France, ¹⁴Clinical Research Unit, Paris, ¹⁵AP-HP, UPEC, Créteil

Meeting: ACR Convergence 2020

Keywords: cytokines, hand, Osteoarthritis, pain, Randomized Trial

Session Information

Date: Sunday, November 8, 2020

Session Title: Osteoarthritis I: Clinical Trials (1482–1486)

Session Type: Abstract Session

Session Time: 4:00PM-4:50PM

Background/Purpose: To evaluate the efficacy of tocilizumab, an antibody against interleukin-6 receptor (IL-6R), in patients with hand osteoarthritis.

Methods: This was a multicenter, 12-week, randomized, double-blind, placebo-controlled study. Patients with symptomatic hand osteoarthritis (pain ≥ 40 on a 0–100-mm visual analogic scale [VAS] despite analgesics and non-steroidal anti-inflammatory drugs; at least 3 painful joints, Kellgren–Lawrence grade ≥ 2) were randomized to receive two infusions 4 weeks apart (week 0 and week 4) of tocilizumab (8 mg/kg IV) or a placebo. The primary endpoint was the change 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 (82% women; mean age, 64.4 years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on VAS pain (primary outcome) was -7.9 (SD 19.4) and -9.9 (SD 20.1) in the tocilizumab and placebo group (p=0.7). No significant treatment differences were observed at weeks 4, 6, 8 or 12 for any secondary outcomes. 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.

Disclosure: P. Richette, None; A. Latourte, None; J. Sellam, None; D. Wendling, None; M. Piperno, Abbvie, 9, Janssen, 9, Biogen, 9, Pfizer, 9, Chugai, 9, Bristol-Myers Squibb, 9, Sandoz, 9; P. Goupille, MSD France, 1, 2, Abbvie, 1, Amgen, 1, Biogaran, 1, 2, BMS, 1, Celgene, 1, Chugai, 1, Lilly, 1, Hospira, 1, Janssen, 1, Medac, 1, Nordic Pharma, 1, Novartis, 1, Sanofi-Genzyme, 1, Pfizer, 1, UCB Pharma, 1; Y. Pers, None; F. Eymard, None; S. Ottaviani, None; P. Ornetti, None; R. Flipo, MSD France, 1, 2, Sanofi-Aventis, 1; B. Fautrel, MSD France, 1, 2, Abbvie, 1, 2, Pfizer, 1, 2, Biogen, 1, BMS, 1, Boehringer Ingelheim, 1, Celgene, 1, Janssen, 1, Lilly, 1, Medac, 1, Nordic Pharma, 1, Novartis, 1, Roche, 1, Sanofi-Aventis, 1, SOBI, 1, UCB Pharma, 1; J. Bertola, Roche-Chugai, 3; E. Vicaut, None; X. Chevalier, None.

To cite this abstract in AMA style:

Richette P, Latourte A, Sellam J, Wendling D, Piperno M, Goupille P, Pers Y, Eymard F, Ottaviani S, Ornetti P, Flipo R, Fautrel B, Bertola J, Vicaut E, Chevalier X. Efficacy of Tocilizumab in Patients with Hand Osteoarthritis: Double Blind, Randomized, Placebo Controlled, Multicenter Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-tocilizumab-in-patients-with-hand-osteoarthritis-double-blind-randomized-placebo-controlled-multicenter-trial/. Accessed April 17, 2021.

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