OBJECTIVE: To evaluate the ability of tocilizumab (a humanised anti-IL-6 receptor antibody) monotherapy to inhibit progression of structural joint damage in patients with RA. METHODS: In a multi-centre, x ray reader-blinded, randomised, controlled trial, 306 patients with active RA of <5 years' duration were allocated to receive either tocilizumab monotherapy at 8 mg/kg intravenously every 4 weeks or conventional disease-modifying antirheumatic drugs (DMARDs) for 52 weeks. Radiographs of hands and forefeet were scored by the van der Heijde modified Sharp method. RESULTS: Patients had a mean disease duration of 2.3 years and a disease activity score in 28 joints of 6.5 at baseline. Mean total modified Sharp score (TSS) was 29.4, which was very high despite the relatively short disease duration. At week 52, the tocilizumab group showed statistically significantly less radiographic change in TSS (mean 2.3; 95% CI 1.5 to 3.2) than the DMARD group (mean 6.1; 95% CI 4.2 to 8.0; p<0.01). Tocilizumab monotherapy also improved signs and symptoms. The overall incidences of AEs were 89% and 82% (serious AEs: 18% and 13%; serious infections: 7.6% and 4.1%) in the tocilizumab and DMARD groups, respectively. CONCLUSION:Tocilizumab monotherapy was generally well tolerated and provided radiographic benefit in patients with RA.
RCT Entities:
OBJECTIVE: To evaluate the ability of tocilizumab (a humanised anti-IL-6 receptor antibody) monotherapy to inhibit progression of structural joint damage in patients with RA. METHODS: In a multi-centre, x ray reader-blinded, randomised, controlled trial, 306 patients with active RA of <5 years' duration were allocated to receive either tocilizumab monotherapy at 8 mg/kg intravenously every 4 weeks or conventional disease-modifying antirheumatic drugs (DMARDs) for 52 weeks. Radiographs of hands and forefeet were scored by the van der Heijde modified Sharp method. RESULTS:Patients had a mean disease duration of 2.3 years and a disease activity score in 28 joints of 6.5 at baseline. Mean total modified Sharp score (TSS) was 29.4, which was very high despite the relatively short disease duration. At week 52, the tocilizumab group showed statistically significantly less radiographic change in TSS (mean 2.3; 95% CI 1.5 to 3.2) than the DMARD group (mean 6.1; 95% CI 4.2 to 8.0; p<0.01). Tocilizumab monotherapy also improved signs and symptoms. The overall incidences of AEs were 89% and 82% (serious AEs: 18% and 13%; serious infections: 7.6% and 4.1%) in the tocilizumab and DMARD groups, respectively. CONCLUSION:Tocilizumab monotherapy was generally well tolerated and provided radiographic benefit in patients with RA.
Authors: Désirée van der Heijde; Lee Simon; Josef Smolen; Vibeke Strand; John Sharp; Maarten Boers; Ferdinand Breedveld; Michael Weisman; Michael Weinblatt; Rolf Rau; Peter Lipsky Journal: Arthritis Rheum Date: 2002-04-15
Authors: E H S Choy; D A Isenberg; T Garrood; S Farrow; Y Ioannou; H Bird; N Cheung; B Williams; B Hazleman; R Price; K Yoshizaki; N Nishimoto; T Kishimoto; G S Panayi Journal: Arthritis Rheum Date: 2002-12
Authors: J Keane; S Gershon; R P Wise; E Mirabile-Levens; J Kasznica; W D Schwieterman; J N Siegel; M M Braun Journal: N Engl J Med Date: 2001-10-11 Impact factor: 91.245
Authors: Gabor G Illei; Yuko Shirota; Cheryl H Yarboro; Jimmy Daruwalla; Edward Tackey; Kazuki Takada; Thomas Fleisher; James E Balow; Peter E Lipsky Journal: Arthritis Rheum Date: 2010-02
Authors: A Picchianti Diamanti; M M Rosado; M Scarsella; V Germano; E Giorda; S Cascioli; B Laganà; R D'Amelio; R Carsetti Journal: Clin Exp Immunol Date: 2014-09 Impact factor: 4.330