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DOI 10.1136/annrheumdis-2020-218547

Медицинская библиотека · Annals of the rheumatic diseases · 2020

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

СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

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.

Для цитирования: 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. Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial.. Annals of the rheumatic diseases. 2020. DOI: 10.1136/annrheumdis-2020-218547.

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