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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
The Lancet - Early Online Publication, 07/01/09

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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