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Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial.
Richette, Pascal; Latourte, Augustin; Sellam, Jérémie; Wendling, Daniel; Piperno, Muriel; Goupille, Philippe; Pers, Yves-Marie; Eymard, Florent; Ottaviani, Sébastien; Ornetti, Paul; Flipo, René-Marc; Fautrel, Bruno; Peyr, Olivier; Bertola, Jean Pierre; Vicaut, Eric; Chevalier, Xavier.
Afiliação
  • Richette P; APHP, Hôpital Lariboisière, Service de Rhumatologie, Paris, France pascal.richette@aphp.fr.
  • Latourte A; Université de Paris, Inserm, UMR-S 1132, Bioscar, Paris, France.
  • Sellam J; APHP, Hôpital Lariboisière, Service de Rhumatologie, Paris, France.
  • Wendling D; Université de Paris, Inserm, UMR-S 1132, Bioscar, Paris, France.
  • Piperno M; Rheumatology, INSERM UMRS_938, Sorbonnes Université UPMC Univ Paris 06, St-Antoine Hospital, DHU i2B, Paris, France.
  • Goupille P; Rheumatology, CHU J Minjoz, Besancon, France.
  • Pers YM; Rheumatology, University Claude Bernard, Lyon, France.
  • Eymard F; Rheumatology, Trousseau University Hospital, Tours, France.
  • Ottaviani S; Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, CHRU Lapeyronie, Montpellier, France.
  • Ornetti P; Department of Rheumatology, APHP Henri Mondor Hospital, Créteil, France.
  • Flipo RM; Universite Paris-Est Creteil Val de Marne, Creteil, Île-de-France, France.
  • Fautrel B; Rheumatology, Hospital Bichat-Claude-Bernard, Paris, Île-de-France, France.
  • Peyr O; Rheumatology, Burgundy Franche-Comté University, Dijon, France.
  • Bertola JP; Dijon University Hospital, Dijon, France.
  • Vicaut E; Service de Rhumatologie, CHU Roger Salengro, Université de Lille, Lille, France.
  • Chevalier X; Rheumatology, Assistance Publique - Hopitaux de Paris, Paris, France.
Ann Rheum Dis ; 80(3): 349-355, 2021 03.
Article em En | MEDLINE | ID: mdl-33055078
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Osteoartrite Tipo de estudo: Clinical_trials / Etiology_studies Limite: Female / Humans / Male / Middle aged Idioma: En Revista: Ann Rheum Dis Ano de publicação: 2021 Tipo de documento: Article País de afiliação: França

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Osteoartrite Tipo de estudo: Clinical_trials / Etiology_studies Limite: Female / Humans / Male / Middle aged Idioma: En Revista: Ann Rheum Dis Ano de publicação: 2021 Tipo de documento: Article País de afiliação: França