Alan Menter1, Diamant Thaçi2, Kim A Papp3, Jashin J Wu4, Mareike Bereswill5, Henrique D Teixeira6, Simone Rubant5, David A Williams6. 1. Baylor University Medical Center, Dallas, Texas. Electronic address: amderm@gmail.com. 2. Comprehensive Center for Inflammation Medicine, University Medical School Schleswig Holstein, Campus Lübeck, Lübeck, Germany. 3. Probity Medical Research, Waterloo, Ontario, Canada. 4. Kaiser Permanente Los Angeles Medical Center, Los Angeles, California. 5. AbbVie Deutschland GmbH and Co KG, Ludwigshafen, Germany. 6. AbbVie Inc, North Chicago, Illinois.
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.
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: R Bissonnette; T Luger; D Thaçi; D Toth; A Lacombe; S Xia; R Mazur; M Patekar; P Charef; M Milutinovic; C Leonardi; U Mrowietz Journal: J Eur Acad Dermatol Venereol Date: 2018-03-22 Impact factor: 6.166
Authors: Bruce Strober; Jeffrey D Greenberg; Chitra Karki; Marc Mason; Ning Guo; Peter Hur; Yang Zhao; Vivian Herrera; Feng Lin; Mark Lebwohl Journal: BMJ Open Date: 2019-04-20 Impact factor: 2.692
Authors: D Thaçi; K Papp; D Marcoux; L Weibel; A Pinter; P-D Ghislain; I Landells; P H Hoeger; K Unnebrink; M M B Seyger; D A Williams; S Rubant; S Philipp Journal: Br J Dermatol Date: 2019-07-25 Impact factor: 9.302
Authors: Caitriona Ryan; Jeffrey M Sobell; Craig L Leonardi; Charles W Lynde; Mahinda Karunaratne; Wendell C Valdecantos; Barbara A Hendrickson Journal: Am J Clin Dermatol Date: 2018-06 Impact factor: 7.403