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Adalimumab for maintaining clinical remission in patients with Crohn's disease
The results from a study showing patients with moderate to severely active Crohn's disease treated with Adalimumab ( Humira ) were more likely to maintain clinical remission through one year than patients receiving a placebo, regardless of the frequency of the dosing regimen.
Data from CHARM ( Crohn's trial of the fully Human antibody Adalimumab for Remission Maintenance ) showed that remission rates were maintained through 56 weeks in patients who demonstrated response to Adalimumab during a four-week open-label induction phase.
Clinical remission was measured by a decrease in the Crohn's Disease Activity Index ( CDAI ). CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, level of general well-being and other measures.
CHARM is a Phase III double-blind, placebo-controlled, multi-center, 56- week trial.
It was designed to assess the efficacy and safety of Adalimumab taken weekly and every other week, versus placebo, in maintaining clinical remission ( CDAI<150 ) at week 26 and week 56 in patients with moderate to severely active Crohn's disease ( CDAI 220-450 ) who responded to open-label induction therapy.
Co-primary endpoints in CHARM were clinical remission rates at week 26 and week 56.
Major secondary endpoints in CHARM included measurement of clinical response ( CDAI decrease by at least 70 and 100 points ), discontinuation of steroids while in remission, fistula counts, and scores from the Inflammatory Bowel Disease Questionnaire ( IBDQ ) and the SF-36, both of which measure health status and quality of life.
The trial included 854 patients who received open-label induction therapy with Adalimumab 80 mg at week zero and 40 mg at week two.
Seventy-six patients withdrew prior to randomization.
All of the remaining 778 patients at week four were randomized to receive Adalimumab 40 mg every other week, Adalimumab 40 mg weekly or placebo through week 56. The 499 patients ( 58 percent ) with week four clinical response to Adalimumab ( a CDAI decrease equal to or greater than 70 from baseline ) made up the primary efficacy analysis group.
At week eight, steroid tapering was permitted for those responding to treatment. All patients with active fistulas at both screening and baseline visits, regardless of their response to Adalimumab during the open-label induction period, were assessed for fistula closure.
The data showed significantly higher remission rates ( CDAI<150 ) at weeks 26 and 56 versus placebo, among patients with a decrease in CDAI greater than or equal to 70 points at week four.
In addition, the percent of patients in clinical remission on the two dosing regimens was comparable. Of the 172 patients treated with Adalimumab every other week, 40 percent were in clinical remission at week 26 ( p<0.001 ) and more than one-third ( 36 percent ) were in remission at week 56 ( p<0.001 ). Of the 157 patients taking Adalimumab weekly, nearly half ( 46 percent ) achieved clinical remission from Crohn's disease at week 26 ( p<0.001 ) and 41 percent maintained remission at week 56 ( p<0.001 ). In comparison, of the 170 patients receiving placebo, 17 percent achieved clinical remission at week 26 and 12 percent maintained remission at week 56.
In CHARM, the proportion of patients in clinical remission at week 26 and week 56 who were able to discontinue steroid use was evaluated. At week 26, 35 percent of patients receiving Adalimumab every other week and 30 percent of patients taking Adalimumab weekly discontinued the use of steroids and remained in remission, compared to 3 percent of patients receiving placebo ( p less than or equal to 0.001 ). At week 56, 29 percent of patients taking Adalimumab every other week and 23 percent of patients taking Adalimumab weekly discontinued the use of steroids and maintained remission, compared to 6 percent of those receiving placebo ( p less than or equal to 0.008 ). Steroids can produce severe adverse effects and are not recommended for long-term treatment.
In CHARM, the ability of Adalimumab to treat draining cutaneous fistulas, the abnormal connections that form between the intestine and the skin in patients with Crohn's disease, was also assessed. Among all patients with draining cutaneous fistulas at both screening and baseline, regardless of response to Adalimumab at week four, one-third of patients ( 33 percent ) achieved complete closure of fistulas when receiving Adalimumab either every other week or weekly ( n=70, p<0.016 ) compared with 13 percent of patients receiving placebo ( n=47 ). Complete fistula closure was defined as no draining fistulas for at least the last two post-baseline evaluations.
