Abstract
Background: Adalimumab (Humira ® , AbbVie Inc., North Chicago, IL, U.S.A.) is a fully human monoclonal antibody specific for tumour necrosis factor-α that is approved to treat adults with moderate-to-severe chronic plaque psoriasis. Objectives: To assess long-term safety for patients with psoriasis receiving adalimumab in clinical studies. Methods: Adalimumab safety data from adults with psoriasis who received at least one adalimumab dose in 18 clinical trials were evaluated. Adalimumab was delivered subcutaneously in all treatment regimens. Treatment-emergent adverse events (AEs) were collected from the first dose to 70 days after the last dose or cut-off date (31 December 2015). AE incidence rates were expressed as events per 100 patient-years (E/100 PYs) of adalimumab exposure. Standardized incidence ratios (SIRs) for malignancies and standardized mortality ratios (SMRs) were calculated. Results: Cumulative exposure was 5429·7 PYs in 3727 patients. Overall, there were 16 536 AEs (304·6 E/100 PYs). The most common AEs were nasopharyngitis, upper respiratory infection and headache (23·7, 12·9 and 7·9 E/100 PYs, respectively). Incidence rates for serious infections, tuberculosis and opportunistic infections were 1·8, 0·3 and 0·02 E/100 PYs, respectively. Incidence of malignancy excluding nonmelanoma skin cancer (NMSC) was 0·8 E/100 PYs [SIR 0·86, 95% confidence interval (CI) 0·58–1·23]. Incidences of NMSC and melanoma were 0·6 and 0·2 E/100 PYs, respectively. The SIR was 1·55 (95% CI 1·10–2·13) for NMSC and 3·04 (95% CI 1·11–6·62) for melanoma. The SMR was 0·34 (95% CI 0·16–0·65). Conclusions: AE rates remained stable in this analysis of patients with psoriasis receiving adalimumab; no new safety signals were identified compared with earlier analyses.
| Original language | English |
|---|---|
| Journal | British Journal of Dermatology |
| Volume | 180 |
| Issue number | 1 |
| Pages (from-to) | 76-85 |
| Number of pages | 10 |
| ISSN | 0007-0963 |
| DOIs | |
| Publication status | Published - 01.2019 |
Funding
The authors would like to acknowledge Winnie Lau and Kun Chen of AbbVie Inc. for statistical analysis support. Medical writing support was provided by Janet Matsuura, Natalia Zhu-kovskaya and Tiffany Brake of Complete Publication Solutions LLC (North Wales, PA, U.S.A.) and was funded by AbbVie Inc. C.L. has received research funding and/or served as a consultant for Actavis, AbbVie, Amgen, Celgene, Coherus, Dermira, Eli Lilly, Galderma, Janssen, Leo, Merck, Novartis, Pfizer, Sandoz, Stiefel, UCB and Wyeth. K.P. has served as a consultant for AbbVie, Amgen, Anacor, Astellas, AstraZeneca, Baxter, Boehringer Ingel-heim, Celgene, Coherus, Dermira, Eli Lilly, Forward Pharma, Gal-derma, Genentech, GlaxoSmithKline, Janssen, Kirin, Kyowa, Leo, Meiji Seika Pharma Co. Ltd., Merck (MSD), Mitsubishi Pharma, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Roche, Serono, Takeda and UCB; served as a speaker for AbbVie, Amgen, Astellas, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Gal-derma, Janssen, Leo, Merck (MSD), Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Serono and UCB; served on an advisory board for AbbVie, Amgen, Astellas, Boehringer Ingelheim, Cel-gene, Eli Lilly, Janssen, Merck (MSD), Mylan, Novartis, Pfizer and UCB; served on the data and safety monitoring board for Astellas and Kyowa; served on steering and/or publication committees for Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis and Pfizer; served as a scientific officer for AbbVie and Anacor; received grant/research support from AbbVie, Amgen, Anacor, Astellas, AstraZeneca, Baxter, Boehringer Ingelheim, Celgene, Coherus, Dermira, Eli Lilly, Forward Pharma, Galderma, Genen-tech, GlaxoSmithKline, Janssen, Kyowa, Leo, Merck (MSD), Mit-subishi Pharma, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Roche, Serono, Takeda and UCB and received honoraria from AbbVie, Amgen, Astellas, Baxter, Boehringer Ingelheim, Celgene, Eli Lilly, Forward Pharma, Galderma, Genentech, Janssen, Kyowa, Meiji Seika Pharma Co. Ltd., Merck (MSD), Mitsubishi Pharma, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Serono, Takeda and UCB. Honoraria paid by AbbVie were for activities that were unrelated to authorship. B.S. has served as a consultant for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Celgene (paid to University of Connecticut), Dermira, GlaxoSmithKline, Janssen, Leo, Eli Lilly, Maruho, Medac, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, Sun, Stie-fel/GlaxoSmithKline, UCB and Valeant; is the scientific director for the CORRONA Psoriasis Registry and has received grant support to the University of Connecticut for a fellowship programme from AbbVie and Janssen. D.T. has received honoraria from AbbVie, Almirall, Amgen, Astellas, Biogen Idec, Boehringer Ingelheim, Celgene, Dignity, Forward Pharma, Galderma, GlaxoSmithKline, Janssen-Cilag, Leo Pharma, Eli Lilly, Maruho, Medac, MedImmune, Merck Sharp & Dohme, Merck-Serono, Novartis, Regeneron, Sandoz, Sanofi-Aventis, Takeda, Pfizer and UCB for participation on advisory boards, as a speaker, and for consultancy; and received research grants from AbbVie, Biogen Idec, Leo Pharma and Pfizer. R.B.W. has served as a consultant for/received research funding from AbbVie, Amgen, Almirall, Boehringer Ingelheim, Celgene, Pfizer, Leo, Janssen, Medac, Novartis, Eli Lilly, UCB and XenoPort. S.T. has served as a clinical investigator for studies sponsored by AbbVie and is a speaker and consultant for AbbVie. D.A. and W.C.V. are employees of AbbVie and may own AbbVie stock/stock options. M.K. is a former employee of AbbVie and may own AbbVie stock/stock options.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
