Nebenwirkungen · Humira
Humira 80 mg solution for injection in pre-filled syringe Humira 80 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 124
HOS-112005 · Präparat HOS-093595
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 1) including spontaneous reporting data 2) The mean weight change from baseline for adalimumab ranged from 0.3 kg to 1.0 kg across adult indications compared to (minus) -0.4 kg to 0.4 kg for placebo over a treatment period of 4-6 months. Weight increase of 5-6 kg has also been observed in long-term extension studies with mean exposures of approximately 1-2 years without control group, particularly in patients with Crohn’s disease and Ulcerative colitis. The mechanism behind this effect is unclear but could be associated with the anti-inflammatory effect of adalimumab.
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