Placebo | 3 mg/kg infiximab | 10 mg/kg infiximab | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
MTX+ | MTX+ | MTX− | MTX+ | MTX− | ||||||
Paulus 20 (% patients) | ||||||||||
2 weeks | 7 | 27 | 43 | 62 | 53 | |||||
14 weeks | 0 | 60 | 57 | 79 | 53 | |||||
26 weeks | 7 | 47 | 21 | 57 | 33 | |||||
Paulus 50 (% patients) | ||||||||||
2 weeks | 0 | 7 | 29 | 15 | 20 | |||||
14 weeks | 7 | 60 | 36 | 62 | 40 | |||||
26 weeks | 0 | 40 | 14 | 50 | 20 | |||||
% improvement in TJC | ||||||||||
2 weeks | 0 | 43 | 55 | 65 | 39 | |||||
14 weeks | N/A3-150 | 71 | 81 | 96 | 52 | |||||
26 weeks | N/A3-150 | 90 | 61 | 96 | 43 | |||||
% improvement in SJC | ||||||||||
2 weeks | 18 | 25 | 47 | 43 | 63 | |||||
14 weeks | N/A3-150 | 75 | 76 | 80 | 63 | |||||
26 weeks | N/A3-150 | 73 | 29 | 70 | 74 |
Adapted from Maini et al.7
One hundred one patients with an incomplete response or flare of rheumatoid arthritis activity while receiving MTX were studied. Patients receiving concomitant MTX continued on doses of 7.5 mg/week, beginning four weeks before randomisation. Infusions of infliximab were given at weeks 0, 2, 6, 10 and 14. Patients were followed up for 26 weeks.
↵3-150 Not available: The number of patients remaining in the trial was less than 50% of the number of patients randomised, therefore summary statistics were not determined.
TJC = tender joint count, SJC = swollen joint count.