Adalimumab ( Humira ) is the key treatment for ulcerative colitis unresponsive or intolerant to standard treatments. The aim of the study was to assess the efficacy and safety of Adalimumab in treating ambulatory in patients with ulcerative colitis in primary gastroenterology centers.
Fifteen patients ( 6 male, median age 29.9 years, range 22.8-39.9 years ) were enrolled. All were previously treated with Infliximab ( Remicade ).
Clinical activity and endoscopic severity were scored according to the Crohn's disease activity index ( CDAI ) score and Mayo subscore for endoscopy, respectively.
Patients were clinically assessed at weeks 4, 8, and thereafter at weeks 16, 24, 32, 40, 48, and 54. Colonoscopy was performed before starting treatment, at weeks 24 and 54.
The co-primary endpoints were clinical remission at 24 and 54 weeks. The secondary endpoints included: 1) sustained clinical remission; 2) steroid-sparing effect; 3) mucosal healing; 4) need for colectomy. Induction dose of Adalimumab was 160 mg at week 0, and then 80 mg at week 2, while Adalimumab maintenance treatment was 40 mg every two weeks.
Clinical remission was obtained in 11 ( 73.3% ) and 15 ( 100% ) patients at weeks 24 and 54 respectively. Ten patients ( 66.7% ) were able to discontinue steroids and were under corticosteroid-free remission at week 54.
No patients underwent to colectomy.
Eight patients ( 53.33% ) at week 24 and 9 patients ( 60% ) at week 54 achieved complete mucosal healing ( Mayo endoscopic score 0 ).
Side effects were reported in 2 of 15 patients ( 13.3% ); none of those patients stopped treatment.
In conclusion, Adalimumab seems to be effective and safe in patients outpatients affected by ulcerative colitis, and previously treated with Infliximab. ( Xagena )
Tursi A et al, Ann Gastroenterol 2014;27:369-373