Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor-alpha inhibitors (GO-AFTER study): A multicentre, randomised, double-blind, placebo-controlled, phase III trial
Smolen JS et al. – Phase III study reports that golimumab (TNFα inhibitor) reduced the signs and symptoms of rheumatoid arthritis in patients with active disease who had previously received one or more TNFα inhibitors.Methods- Aim was to assess the efficacy and safety of the golimumab in pts with active RA who had previously received one or more TNFα inhibitors
- 461 pts, randomly allocated to receive sc injections of placebo (n=155), 50 mg golimumab (n=153), or 100 mg golimumab (n=153) every 4 wks between Feb 21, 2006, and Sept 26, 2007
- Eligible pts had been treated with at least one dose of a TNFα inhibitor previously
- Pts continued stable doses of MTX, sulfasalazine, hydroxychloroquine, oral corticosteroids, and NSAIDs
- Primary endpoint: achievement at wk 14 of ACR20
- At wk 16, pts who had <20% improvement in tender and swollen joint counts were given rescue therapy:
- changed treatment from placebo to 50 mg golimumab, or
- from 50 mg to 100 mg golimumab
- Drug efficacy was assessed by intention to treat and safety was assessed according to the study drug given
Results- Pts had discontinued previous TNFα inhibitors because of lack of effectiveness or intolerance and accessibility issues
- Pts had active disease, which was indicated by swollen and tender joints for the whole group
- 18% pts on placebo, 35% pts on 50 mg golimumab and 38% pts on 100 mg golimumab achieved ACR20 at wk 14
- 2 pts were never treated, and 57 pts did not complete the study because of AEs, unsatisfactory treatment effect, loss to f/u, death, or other reasons
- 155 pts on placebo, 153 on 50 mg golimumab, and 153 on 100 mg golimumab were assessed for drug efficacy
- For wks 1-16, serious AEs were recorded in 7% pts on placebo, 5% on 50 mg golimumab, and 3% on 100 mg golimumab
- For wks 1-24, after some pts were given rescue therapy, serious AEs were recorded in 10% pts on placebo, 5% on 50 mg golimumab, and 4% on 100 mg golimumab
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