002)
a: Reduction in CDAI 25% and 70 points.
b: CDAI<150 at both Week 30 and 54 and not receiving corticosteroids in the 3 months prior to Week 54 among patients who were receiving corticosteroids at baseline.
Beginning at week 14, patients who had responded to treatment, but subsequently lost their clinical benefit, were allowed to cross over to a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised. Eighty-nine percent (50/56) of patients who lost clinical response on infliximab 5 mg/kg maintenance therapy after week 14 responded to treatment with infliximab 10 mg/kg.
Improvements in quality of life measures, a reduction in disease-related hospitalizations and corticosteroid use were seen in the infliximab maintenance groups compared with the placebo maintenance group at weeks 30 and 54.
Infliximab with or without AZA was assessed in a randomized, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI 220 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years. At baseline 27.4% of patients were receiving systemic corticosteroids, 14.2% of patients were receiving budesonide, and 54.3% of patients were receiving 5-ASA compounds. Patients were randomized to receive AZA monotherapy, infliximab monotherapy, or infliximab plus AZA combination therapy. Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks. AZA was given at a dose of 2.5 mg/kg daily.
The primary endpoint of the study was corticosteroid-free clinical remission at Week 26, defined as patients in clinical remission (CDAI of <150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose > 6 mg/day. For results see Table 6. The proportions of patients with mucosal healing at Week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p<0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Table 6: Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC
AZA
Monotherapy
Infliximab
Monotherapy
Infliximab + AZA
Combination Therapy
Week 26
All randomized patients
30.0% (51/170)
44.4% (75/169)
(p=0.006)*
56.8% (96/169)
(p<0.001)*
* P-values represent each infliximab treatment group vs. AZA monotherapy
Similar trends in the achievement of corticosteroid-free clinical remission were observed at Week 50. Furthermore, improved quality of life as measured by IBDQ was observed with infliximab.
Induction treatment in fistulising active Crohn's disease
The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulae that were of at least 3 months' duration. Thirty-one of these patients were treated with infliximab 5 mg/kg. Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies. Patients received three doses of either placebo or infliximab at weeks 0, 2 and 6. Patients were followed up to 26 weeks. The primary endpoint was the proportion of patients who experienced a clin |
