Evaluation of the safety and effectiveness after switch from adalimumab originator to biosimilar SB5 in patients with inflammatory bowel disease in a real-life setting.

Background and study aims: Prospective data are lacking on evolution of trough levels, effectiveness, acceptance rate and patient satisfaction after switch from the adalimumab originator to a biosimilar in patients with inflammatory bowel disease. Patients and methods: Patients in clinical remission or stable response and treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, prospective trial in which patients were switched to adalimumab biosimilar SB5. The primary outcome was the description of adalimumab trough levels over time. Secondary outcomes were secondary loss of response, disease activity, patient satisfaction score and drug persistence over 12 months. Results: The study included 110 patients. Mean baseline adalimumab trough level was 9.21 µg/ml. Concentration remained within the therapeutic range over time. No changes were observed in disease activity scores nor in biochemical parameters over time. The acceptance rate of switch was 84.6%. By month 12, 74.5% was still treated with SB5. The most frequent reason for discontinuation was occurrence of adverse events. 50% of these adverse events were injection site pain. The local discomfort was only significant the first 30 minutes after injection. Satisfaction with the decision to switch to SB5 was high and remained stable over time. Conclusions: After being well informed the great majority of patients treated with the adalimumab originator is willing to switch to biosimilar SB5. In our study, there was a persistence rate of 75% over one year. The trough levels remained within the therapeutic range and no change in disease activity was seen over time.

An atypical cause of right lower abdominal pain: amoebiasis, a family cluster.

In this case report we present a family cluster of amoebiasis in a nonendemic region. A 46-year-old women, diagnosed with Crohn's disease for which she received no maintenance therapy, was evaluated for the suspicion of a flare. At colonoscopy however, atypical findings for Crohn's disease were seen. Histopathologic examination revealed micro-organisms compatible with amoebiasis. Interestingly, 4 years before this event she started a new relationship with a 38-year-old man who was diagnosed with liver-amoebiasis 3 months after the start of their relationship. On top of this, her 18-year-old daughter was diagnosed with amoebiasis 2 years after her diagnosis. The source of the infection remains unknown, but we speculate that the infection was transmitted feco-orally between the different members of this family. These cases illustrate that we should be aware of parasitological causes of colitis, especially in patients with atypical endoscopic images or when a close "relative" is diagnosed with amoebiasis.

Osler-Rendu-Weber with liver involvement.

Osler-Rendu-Weber disease, or hereditary hemorrhagic telangiectasia, is a vascular disease with autosomal dominant transmission. The liver is involved in 31% of patients with hereditary hemorrhagic telangiectasia (1). It appears that the lesions uncommonly causes serious disease. We report the imaging findings and the therapy in a case with extensive telangiectasis in the liver.