Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p< 0.001). In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ. Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in IMPACT 2.
Adult psoriasis
The efficacy of infliximab was assessed in two multicenter, randomised, double blind studies: SPIRIT and EXPRESS. Patients in both studies had plaque psoriasis (Body Surface Area [BSA] 10% and Psoriasis Area and Severity Index [PASI] score 12). The primary endpoint in both studies was the percent of patients who achieved 75% improvement in PASI from baseline at week 10.
SPIRIT eva luated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy. Patients received either 3 or 5 mg/kg infliximab or placebo infusions at weeks 0, 2 and 6. Patients with a PGA score 3 were eligible to receive an additional infusion of the same treatment at week 26.
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001). By week 26, twenty weeks after the last induction dose, 30% of patients in the 5mg/kg group and 13.8% of patients in the 3mg/kg group were PASI 75 responders. Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks. No rebound was observed.
EXPRESS eva luated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis. Patients received 5 mg/kg infliximab or placebo infusions at weeks 0, 2 and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group. At week 24, the placebo group crossed over to infliximab induction therapy (5 mg/kg) followed by infliximab maintenance therapy (5 mg/kg). Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI). Prior therapy with PUVA, methotrexate, cyclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant. Key results are presented in Table 10. In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6). Efficacy was similar in the subgroup of patients that were exposed to previous systemic therapies compared to the overall study population.
Table 10
Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50. EXPRESS.
Placebo Infliximab
5 mg/kg (at week 24)
Infliximab
5 mg/kg
Week 10
N
77
301
90% improvement
1 (1.3%)
172 (57.1%)a
75% improvement
2 (2.6%)
242 (80.4%)a
50% improvement
6 (7.8%)
274 (91.0%)
PGA of cleared (0) or minimal (1)
3 (3.9%)
242 (82.9 |
