Efalizumab, a human monoclonal anti-CD11a antibody, in the treatment of moderate to severe Crohn's Disease: an open-label pilot study.

BACKGROUND AND AIMS: Efalizumab is a monoclonal antibody targeting CD11a, an adhesion molecule involved in the activation and trafficking of T-lymphocytes. This agent has proven efficacy in the treatment of psoriasis. We performed an open-label study to evaluate the efficacy and safety of efalizumab in Crohn's disease (CD). METHODS: Fifteen subjects with moderate to severe CD (Crohn's Disease Activity Index [CDAI] score 220-450) and who were refractory or intolerant to standard therapy, received a weekly 1 mg/kg subcutaneous injection of efalizumab for 8 weeks. The primary endpoint was clinical response (decrease in the CDAI score of at least 70 points) at week 8. Secondary endpoints included change in mean CDAI scores, the proportion of subjects who achieved clinical remission (CDAI score ≤ 150), change in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores, and report of adverse events. RESULTS: At 8 weeks, ten (67%) subjects had clinical response and six (40%) were in remission. The mean baseline and week 8 CDAI scores were 300 and 167 respectively (P < 0.001). Mean IBDQ scores at baseline and week 8 were 124 and 168 respectively (P < 0.001). One subject with Crohn's colitis had pre- and post-treatment colonoscopy that demonstrated mucosal healing. No serious adverse events occurred. CONCLUSIONS: Efalizumab induced a clinical response in the majority of subjects with moderate to severe CD in this small, open-label pilot study. There were no serious adverse events reported during this short-term trial.

Use of safe cribs and bedroom size among African American infants with a high rate of bed sharing.

BACKGROUND: Impoverishment and crowding are associated with an increased risk of sudden unexpected death among infants. Bed sharing likely increases this risk, particularly among African American infants. OBJECTIVES: To compare the sleep environment of African American infants who bed share with that of infants who do not share sleep surfaces and to compare access to a safe crib, and the space available for it, in the sleeping rooms of both groups of infants. METHODS: Home visits were made at approximately age 2 weeks to the homes of serially enrolled African American infants born between July 15, 2001, and November 1, 2001. Questionnaires were used to survey sleep practices, especially sleep surface used. The area of the floor space of rooms used for sleeping was calculated. A portable crib was provided for infants lacking access to safe sleep surfaces. RESULTS: Of these infants, 42 (41%) usually bed shared and 60 (59%) slept alone. The areas of the floor spaces were similar (mean +/- SD, 13.8 +/- 3.3 m(2) for bed sharers vs 12.7 +/- 3.7 m(2) for those who slept alone; 95% CI for difference, -0.34 to 2.51 m(2)). Infants sleeping alone were much more likely to have access to a safe crib (51 of 60 vs 13 of 42; P<.001), and 53 cribs were provided. Follow-up telephone calls made at approximately age 7 months to 43.4% of recipients suggested that the cribs were used on most nights, were durable, and were enthusiastically received. CONCLUSIONS: Crowding is not a strong explanation for bed sharing among impoverished African American infants in St Louis, Mo, who often bed share because there is not a safe crib available. Providing safe cribs may reduce the prevalence of bed sharing.