REAL WORLD EFFECTIVENESS of INITIATING TOPICAL THERAPY COMPARED with INITIATING APREMILAST EARLY or LATE

Document Type

Conference Proceeding

Publication Date

6-26-2024

Publication Title

Acta Derm Venereol

Keywords

apremilast, adult, body surface, conference abstract, cycling, diagnosis, drug therapy, electronic medical record, female, human, major clinical study, male, middle aged, observational study, prescription, probability, psoriasis, psoriatic arthritis, retrospective study, risk factor, systemic therapy, therapy, topical treatment, treatment failure

Abstract

Introduction: The International Psoriasis Council recommends considering systemic therapy based on special area involvement, topical treatment failure, or body surface area (BSA). This approach enables patients with significant disease impact to be identified earlier and advance to appropriate therapy. Objectives: Assess real world effectiveness of topical initiators (TI) compared with early or late apremilast initiators (EAI or LAI), measured by change in BSA and achievement of treatment targets, from pre-initiation to 6 and 12 months post-initiation. Methods: A retrospective observational study was conducted in the OM1 database, including electronic medical records and claims data. Patients included systemic-naive adults with a psoriasis diagnosis, a first observed BSA value between 1% and =10% (index date), no prior evidence of psoriatic arthritis, and =365 days of baseline data, and had either initiated apremilast or a topical prescription of a second type between 2014 and 2022 after index date. EAI and LAI were defined as patients with initiation =6 and >6 months after index date, respectively. Outcomes included mean BSA, achievement of BSA =1% (in patients with a baseline BSA >1%), and =75% improvement in BSA (BSA-75) after 6 and 12 months of apremilast or index topical initiation. Relative risks (RR) for achieved outcomes were estimated using a Poisson model for a three-way comparison between EAI, LAI, and TI. Adjustments were made based on the index BSA value; potential confounding and differential censoring were addressed using inverse probability of treatment and missingness weights (to account for missing BSA outcomes) for the study population. Results: The study included 9,777 TI, 2,073 EAI, and 1,516 LAI. Baseline characteristics are shown in Table 1; mean age and sex were balanced across the groups. Mean index BSAs were 4.6%, 6.0%, and 4.9% for TI, EAI, and LAI, respectively. The median number of days between index BSA and treatment initiation were 0, 16, and 485, for TI, EAI, and LAI, respectively. At treatment initiation, BSA was 4.8%, 6.1%, and 7.3% for TI, EAI, and LAI, respectively (Table 2). For TI, mean BSA at 6 and 12 months post-initiation was 5.5% and 5.3%. At 6 months, the proportion of patients achieving BSA =1% (RR [95% CI]) was significantly higher for EAI (1.54 [1.27, 1.87]) and LAI (1.56 [1.25, 1.95]) versus TI; additionally, the proportion of patients achieving a BSA-75 was significantly higher for EAI (1.52 [1.21, 1.89]) and LAI (1.59 [1.24, 2.03]) versus TI. At 12 months, the proportion of patients achieving BSA =1% was significantly higher for EAI versus TI, and BSA-75 was significantly higher for EAI and LAI versus TI. Conclusions: Topical cycling is a recognized treatment pattern in clinical care. We investigated effectiveness of this approach versus early and delayed systemic therapy. We found EAI were 54% and 52% more likely to achieve BSA =1% and BSA-75 goals, respectively, at 6 months compared to those who received topical therapy alone. The BSA among TI remained similar out to 12 months. Earlier initiation of apremilast could attenuate patient life course impairment related to topical cycling in mildto-moderate psoriasis.2,3.

Volume

104

First Page

43

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