Background: The endoscopic substudy of the ACCENT I (A Crohn’s Disease Clinical Trial Evaluating Infliximab in a New Long-term Treatment Regimen) Crohn’s disease trial examined the effects of infliximab on mucosal i...Background: The endoscopic substudy of the ACCENT I (A Crohn’s Disease Clinical Trial Evaluating Infliximab in a New Long-term Treatment Regimen) Crohn’s disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their impact on outcomes. Design: ACCENT I was a randomized, double-blind, parallel group study. Setting: This study took place at multiple centers in North America, Europe, and Israel. Main Outcome Measurements: Ileocolonoscopic examinations were performed at weeks 0, 10, and 54. Complete mucosal healing was defined as the Absence of all mucosal ulcerations. The end point of principal interest was the proportion of patients randomized as responders with mucosal healing at week 10. The proportion of responderswho demonstrated mucosal healing at week 54 or at both weeks 10 and 54 is also summarized. Changes in Crohn’s disease endoscopic index of severity (CDEIS) scores from baseline to week 10 and 54 were calculated for all patients in this substudy. Results: Complete mucosal healing by week 10 occurred in significantly more week 2 responders who had received 3 doses of infliximab compared with a single dose (31% vs. 0% , p = 0.010). A significantly higher proportion of week 2 responders in the combined scheduled maintenance group had complete mucosal healing at week 54 compared with the episodic group (50% vs. 7% , p = 0.007). The results for all patients are consistent with those for week 2 responders only. Significantly greater improvement in the CDEIS occurred with scheduled maintenance compared with episodic treatment at week 10 (p ≤ 0.001) and week 54 (p = 0.026). Notably, no strong relationship between clinical remission and complete mucosal healing was found. Overall, mucosal healing appeared to correlate with fewer hospitalizations, although these results were not statistically significant. Conclusions: Scheduled infliximab maintenance therapy resulted in more improvement in mucosal ulceration and in higher rates of mucosal healing. There was a numerical trend for patients with better mucosal healing to have a lower rate of Crohn’s disease-related hospitalizations.展开更多
Background: Psoriasis is a chronic disease that significantly diminishes the health- related quality of life (HRQOL). Infliximab is a chimeric, tumour necrosis factor α monoclonal antibody that has been shown to impr...Background: Psoriasis is a chronic disease that significantly diminishes the health- related quality of life (HRQOL). Infliximab is a chimeric, tumour necrosis factor α monoclonal antibody that has been shown to improve the signs and symptoms of plaque psoriasis. Objectives: The objective of this study was to evaluate the effect of infliximab induction therapy on the HRQOL of patients with severe plaque psoriasis. Methods: In this double- blind, placebo- controlled trial, 249 patients were randomly assigned to receive intravenous infusions of 3 or 5 mg kg- 1 of infliximab or placebo and were treated at weeks 0, 2 and 6. Patients completed the Dermatology Life Quality Index (DLQI) at baseline and week 10. Results: Infliximab induction therapy resulted in a substantial improvement in HRQOL. At week 10, patients in the infliximab 3- and 5- mg kg- 1 groups showed a median percentage improvement in DLQI scores of 84.0% and 91.0% , respectively, compared with 0% in the placebo group (P < 0.001). The median decrease from baseline in DLQI score at week 10 was 8.0 and 10.0 for the 3 and 5 mg kg- 1 infliximab groups, respectively, compared with 0 in the placebogroup(P < 0.001). Thirty- three per cent and 40% of patientsinthe 3 and 5 mgkg- 1 infliximab groups, respectively, had a DLQI score of 0 at week 10, compared with 2% in the placebo group (P < 0.001). There was a strong correlation between the percentage change from baseline at week 10 in Psoriasis Area and Severity Index (PASI) scores and the percentage change in DLQI scores during the same period (Spearman’ s correlation, 0.61, P < 0.001). When the infliximab and placebo treatment groups were combined, patients with at least 75% improvement in PASI scores between baseline and week 10 had a greater mean improvement in DLQI scores (81% ) than those with 50- 75% improvement in PASI during the same period (60% ). Conclusions: Infliximab induction therapy resulted in significant improvement in HRQOL in patients with severe psoriasis.展开更多
文摘Background: The endoscopic substudy of the ACCENT I (A Crohn’s Disease Clinical Trial Evaluating Infliximab in a New Long-term Treatment Regimen) Crohn’s disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their impact on outcomes. Design: ACCENT I was a randomized, double-blind, parallel group study. Setting: This study took place at multiple centers in North America, Europe, and Israel. Main Outcome Measurements: Ileocolonoscopic examinations were performed at weeks 0, 10, and 54. Complete mucosal healing was defined as the Absence of all mucosal ulcerations. The end point of principal interest was the proportion of patients randomized as responders with mucosal healing at week 10. The proportion of responderswho demonstrated mucosal healing at week 54 or at both weeks 10 and 54 is also summarized. Changes in Crohn’s disease endoscopic index of severity (CDEIS) scores from baseline to week 10 and 54 were calculated for all patients in this substudy. Results: Complete mucosal healing by week 10 occurred in significantly more week 2 responders who had received 3 doses of infliximab compared with a single dose (31% vs. 0% , p = 0.010). A significantly higher proportion of week 2 responders in the combined scheduled maintenance group had complete mucosal healing at week 54 compared with the episodic group (50% vs. 7% , p = 0.007). The results for all patients are consistent with those for week 2 responders only. Significantly greater improvement in the CDEIS occurred with scheduled maintenance compared with episodic treatment at week 10 (p ≤ 0.001) and week 54 (p = 0.026). Notably, no strong relationship between clinical remission and complete mucosal healing was found. Overall, mucosal healing appeared to correlate with fewer hospitalizations, although these results were not statistically significant. Conclusions: Scheduled infliximab maintenance therapy resulted in more improvement in mucosal ulceration and in higher rates of mucosal healing. There was a numerical trend for patients with better mucosal healing to have a lower rate of Crohn’s disease-related hospitalizations.
文摘Background: Psoriasis is a chronic disease that significantly diminishes the health- related quality of life (HRQOL). Infliximab is a chimeric, tumour necrosis factor α monoclonal antibody that has been shown to improve the signs and symptoms of plaque psoriasis. Objectives: The objective of this study was to evaluate the effect of infliximab induction therapy on the HRQOL of patients with severe plaque psoriasis. Methods: In this double- blind, placebo- controlled trial, 249 patients were randomly assigned to receive intravenous infusions of 3 or 5 mg kg- 1 of infliximab or placebo and were treated at weeks 0, 2 and 6. Patients completed the Dermatology Life Quality Index (DLQI) at baseline and week 10. Results: Infliximab induction therapy resulted in a substantial improvement in HRQOL. At week 10, patients in the infliximab 3- and 5- mg kg- 1 groups showed a median percentage improvement in DLQI scores of 84.0% and 91.0% , respectively, compared with 0% in the placebo group (P < 0.001). The median decrease from baseline in DLQI score at week 10 was 8.0 and 10.0 for the 3 and 5 mg kg- 1 infliximab groups, respectively, compared with 0 in the placebogroup(P < 0.001). Thirty- three per cent and 40% of patientsinthe 3 and 5 mgkg- 1 infliximab groups, respectively, had a DLQI score of 0 at week 10, compared with 2% in the placebo group (P < 0.001). There was a strong correlation between the percentage change from baseline at week 10 in Psoriasis Area and Severity Index (PASI) scores and the percentage change in DLQI scores during the same period (Spearman’ s correlation, 0.61, P < 0.001). When the infliximab and placebo treatment groups were combined, patients with at least 75% improvement in PASI scores between baseline and week 10 had a greater mean improvement in DLQI scores (81% ) than those with 50- 75% improvement in PASI during the same period (60% ). Conclusions: Infliximab induction therapy resulted in significant improvement in HRQOL in patients with severe psoriasis.
