Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis - 17/08/15
, Diamant Thaçi, MD b, Kim A. Papp, MD c, Jashin J. Wu, MD d, Mareike Bereswill, MS e, Henrique D. Teixeira, PhD f, Simone Rubant, PhD e, David A. Williams, MD fAbstract |
Background |
ESPRIT is an ongoing, 10-year, observational registry, evaluating long-term safety and effectiveness of adalimumab treatment in routine clinical practice for patients with moderate to severe, chronic plaque psoriasis.
Objectives |
Initial 5-year results are reported.
Methods |
Two populations were analyzed: the “all-treated” population received 1 or more adalimumab doses in registry, continuing adalimumab treatment from a current prescription or previous study participation, and included the “new-prescription” population initiating adalimumab 4 weeks or earlier preregistry entry.
Results |
Data were collected from September 26, 2008, through November 30, 2013, for all-treated (n = 6059), which included new-prescription (n = 2580, 42.6%); median registry exposure was 765 and 677 days, respectively. In all-treated, rate (events per 100 patient-years of total adalimumab exposure [E/100PY]) of serious treatment-emergent adverse events (inside or outside of the registry) was 4.3 E/100PY, serious infection 1.0 E/100PY, malignancies 0.9 E/100PY (nonmelanoma skin cancers 0.6 E/100PY; melanomas <0.1 E/100PY). Standardized mortality ratio was 0.30 (95% confidence interval 0.19-0.44). Physician Global Assessment clear or minimal (effectiveness parameter) was achieved by 57.0% at 12 months and 64.7% at 60 months of treatment.
Limitations |
Observational data are subject to outcome-reporting bias.
Conclusion |
No new safety signals were observed with adalimumab treatment during this initial 5-year registry review. Observed number of deaths was below expected. As-observed effectiveness remained stable through 60 months.
Il testo completo di questo articolo è disponibile in PDF.Key words : adalimumab, adverse events, long-term safety, malignancy, registry, serious infections
Abbreviations used : AE, E/100PY, MI, PGA, PY, TB, TEAE
Mappa
| AbbVie funded this registry and participated in the design and conduct of the study; collection, management, analysis, and interpretation of data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. All authors were also involved in the decision to submit the manuscript for publication, and had the right to accept or reject comments or suggestions. A medical writer employed by AbbVie participated in the writing of this manuscript, and is acknowledged. |
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| Disclosure: Dr Menter received grants and honoraria from AbbVie, Amgen, Janssen, and Wyeth for participation on advisory boards and as a consultant, investigator, and speaker, and from Stiefel as a consultant and investigator; received grants from Allergan, Celgene, Novartis, Novo Nordisk, Pfizer, and Syntrix Biosystems for participation as an investigator, and from Eli Lilly as an investigator and consultant; and received honoraria from Galderma for participation on advisory boards and as a consultant and investigator, and from Leo Pharma as a consultant and speaker. Prof Dr Thaçi received honoraria for serving on advisory boards for AbbVie, Amgen, Biogen-Idec, Celgene, Eli Lilly, Janssen, Leo Pharma, MSD, Novartis, Pfizer, and Regeneron, and for serving as a consultant for AbbVie, Dignity, Leo Pharma, L'Oreal, Mitsubishi, Regeneron, Sanofi, Sandoz, and Xenoport; received speaker's fees from AbbVie, Amgen, Biogen-Idec, Celgene, Janssen, Leo Pharma, Medac, Novartis, Pfizer, Roche-Possay, and Stiefel and research grants from AbbVie and Pfizer. Dr Wu received research funding from AbbVie, Amgen, Coherus Biosciences, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, and Sandoz; and received honoraria for serving as a consultant for AbbVie, Amgen, Celgene, Dermira, DUSA Pharmaceuticals, Eli Lilly, and Pfizer. Dr Papp received honoraria or grants from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Kyowa, Leo Pharma, Merck, Novartis, and Pfizer for participation on advisory boards, and for participation as a consultant and investigator. Drs Williams, Rubant, and Teixeira, and Ms Bereswill each receive a salary as employees of AbbVie and receive stock and/or stock options. |
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| Supplemental information and tables are available at www.jaad.org. |
Vol 73 - N° 3
P. 410 - settembre 2015 Ritorno al numero
Articolo precedente
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