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Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Humira, and in accordance with local recommendations. Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.In monotherapy, some patients who experience a decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week. The highest frequency seen among the various indications has been included. In the Phase 3 trial of Humira in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.In controlled Phase 3 trials of Humira in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of Humira-treated patients and 1.8% of control-treated patients. Subjects may also have previously lost response or been intolerant to infliximab. Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).Psoriasis Study II (CHAMPION) compared the efficacy and safety of Humira Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an open-label extension trial, where Humira was given for at least an additional 108 weeks.In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 17 and 18).In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p < 0.001, experienced “loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a