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Adalimumab safety update finds no new signals.


A LONG-TERM INTEGRATED analysis of safety data for adalimumab (Humira) in 18 trials includes 5 not included in a 2009 analysis found no new safety signals, investigators reported.

Adverse event incidence rates were expressed as events per 100 patient-years of exposure to adalimumab and among the 3,727 patients who were aged 18 years or older and had moderate to severe plaque psoriasis for at least 6 months, there were 5,430 patient-years of cumulative exposure at the December 2015 cutoff date.

There were 3,798 treatment-related events (70 events /100 patient-years); 269 events (5 events/100 patient-years) led to discontinuation of treatment. Rates of serious adverse events and serious infections were 8.4 and 1.8 events per 100 patient-years, respectively; the most common types of serious infections were pneumonia and cellulitis.

Rates of the most frequently reported adverse events were comparable with those in the 2009 data set; the most common were nasopharyngitis, upper respiratory tract infection, and headache. Rates of serious adverse events, serious infections, and malignancies were also stable, and were mostly consistent with what has been seen in large real-world registries.

Rates of melanoma and nonmelanoma skin cancer were higher than would be expected in the general population, which might be partly explained by more frequent skin examinations, the authors said.

The analysis had limitations, including the lack of a long-term comparator group, they noted.

Six authors reported disclosures with pharmaceutical companies, including serving as a consultant, speaker, and / or adviser for, receiving honoraria from, and /or receiving grant/research support from AbbVie, which funded/advised this study; three authors are current or former AbbVie employees.


SOURCE: Leonardi C et al. Br J Dermatol. 2018 Aug 31. doi: 10.1111/bjd.17084.

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Title Annotation:PSORIASIS
Author:Palmer, Christopher
Publication:Dermatology News
Article Type:Brief article
Date:Nov 1, 2018
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