Gastroenterology Xagena

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Crohn's disease: efficacy and safety of Adalimumab 80 mg weekly

Optimizing anti-tumor necrosis factor therapy is often required in patients with Crohn's disease. In case of partial response or loss of response to Adalimumab ( Humira ) 40 mg every other week, the interval between injections can be shortened. The efficacy and safety profile of Adalimumab 80 mg weekly is unknown.

This was a multicentric prospective observational study. During the period 2011-2012, all adult Crohn’s disease patients receiving Adalimumab 80 mg weekly in a referral center and with an active disease defined by at least a CDAI greater than 150 were enrolled in this prospective study.
CDAI, biological markers and adverse events were recorded at each clinical visit through week 26.

A total of 60 patients were included. Researchers have excluded 19 patients for the efficacy analysis who did not complete the study and with ongoing follow-up. The median age was 33 years and median disease duration was 7 years ( range, 1–48 ).
Optimization to Adalimumab 80 mg weekly was performed following induction therapy after a median duration of 69 weeks.
Adalimumab was associated with steroids and immunomodulators in 28% ( n = 15 ) and 10% ( n = 4 ) of cases, respectively.

After a median follow-up of 15 weeks, 18 of 41 patients ( 44% ) achieved clinical remission ( CDAI less than 150 ) and 61% had a 70-points clinical response.
The cumulative probabilities of clinical remission were 8% and 36% at weeks 4 and 12, respectively.

The median CRP level decreased from 15 mg/L at baseline to 6 mg/L at last news.

There were no death and no serious adverse events. Among the 60 patients, during the follow-up, 23 adverse events were reported in 19 ( 46% ) patients.
Eight patients experienced an infectious event leading to a decrease in the dose for 2 patients and Adalimumab withdrawal for one subject. All infectious events had a favorable outcome after specific treatment.
Four patients developed skin lesions, including neutrophilic dermatosis, psoriasiform skin lesions, peripheral eczema and injection site reactions leading to a decrease in the dose for two patients and Adalimumab withdrawal for one patient.
Mood disorder ( leading to Adalimumab withdrawal ), blood hypereosinophilia, thrombocytosis and hyperleucocytosis, elevated auto-antibody, hypoalbuminemia, and vagal reaction were also reported.

This is the first study assessing efficacy and safety profile of Adalimumab 80 mg weekly. Adalimumab 80 mg weekly was well tolerated and effective in inducing clinical remission in Crohn’s disease in this prospective study. ( Xagena )

Source: Bouguen G et al, 8th Congress of ECCO, 2013