药物警戒杂志

抽象的

Cutaneous Adverse Reactions during Anti-Tnf Alpha Treatment for Inflammatory Bowel Diseases: The Experience of the Dermatology Clinic of Cagliari

Atzori L, Mantovani L, Pinna AL, Pau M and Usai P

Background

Anti-tumour necrosis factor alpha are a well-documented class of disease-modifying therapy for inflammatory bowel diseases, including Crohn's disease and ulcerative colitis. The monoclonal anti-TNFα antibody Infliximab and Adalimumab are the current approved drugs in Italy, showing high efficacy, but also variable clinically significant adverse effects.

Method

From 2012, an observational prospective study was activated at the Dermatology Clinic of Cagliari University, to screen all patients with inflammatory bowel diseases treated with Infliximab and Adalimumab for cutaneous adverse reactions and skin cancers. A basal visit, complete of melanocytic lesions digital image recording was performed in all patients referred from the Gastroenterology Unit of the same University Hospital. Subsequent visits were performed when new lesions or modification of the skin appearance occurred. All cutaneous adverse reactions associated with anti-TNF treatment were reported to the Italian Pharmacovigilance network.

Results

Ninety-one patients were included in the study: 58 (31 women and 27 men) patients affected by Crohn's disease, (the age range was between 16 and 69 years), and 33 patients with ulcerative colitis (15 women and 17 men; age range between 21 and 68 years). Proportion of patients treated with infliximab (52%) was similar to adalimumab (48%). Cutaneous adverse reactions were observed in 38 patients (42%): 20 were taking Infliximab (52%) and 18 Adalimumab (48%). Adverse reactions observed by frequency included: infections (32%), eczematous dermatitis (23%), infusion systemic reactions and at the injection site (5.7%), psoriasis paradoxical reaction (5.7%), followed by a mixture of different cutaneous reactions, including urticaria, photosensitivity, chronic lupus erythematosus, lichenoid eruption, alopecia areata, hypertrichosis. Benign skin tumors eruption (15%) and basal cell carcinoma (2.8%) occurrence were also noted. Patient with dysplastic melanocytic nevi (10%) at screening were regularly followed with digital dermoscopy, but no one showed changes in the study period.

Conclusion

Our sample of patients had a high rate of skin adverse reactions (42%), but considering severity, no case required definitive discontinuation of therapy. Dermatologist support might be critical to optimize biological agent management in inflammatory bowel diseases, performing a careful basal screening, strict monitoring of adverse reactions and prompt intervention, as well as educating the patient towards skin cancer prevention, considering the long-term drug exposure.