Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis.

Abstract

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.

• Authors: Alan Menter, Diamant Thaçi, Kim A Papp, Jashin J Wu, Mareike Bereswill, Henrique D Teixeira, Simone Rubant, David A Williams
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 73 Issue 3 Pg. 410-9.e6 (Sep 2015) ISSN: 1097-6787 [Electronic] United States
• PMID: 26190240 (Publication Type: Comparative Study, Evaluation Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal
• Adalimumab

Topics

• Adalimumab (administration & dosage, adverse effects)
• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Canada
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• Patient Safety
• Product Surveillance, Postmarketing (methods)
• Psoriasis (diagnosis, drug therapy, mortality)
• Registries
• Retrospective Studies
• Risk Assessment
• Severity of Illness Index
• Survival Rate
• Time Factors
• Treatment Outcome
• United States