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Abstract Number: 1569

Persistence of Biologic Therapy in Psoriatic Disease: Results from the Psoriasis Longitudinal Assessment and Registry

Alan Menter1, Kim Papp2, Gerald G. Krueger3, Matthias Augustin4, Francisco Kerdel5, Melinda Gooderham6, Kavitha Goyal7, Steve Fakharzadeh8, Wayne Langholff9, Jan Sermon10, Steve Calabro7 and David Pariser11, 1Baylor Research Institute, Dallas, TX, 2Probity Medical Research, Waterloo, ON, Canada, 3Dermatology, University of Utah, Salt Lake City, UT, 4University Clinics of Hamburg, Hamburg, Germany, 5University of Miami, Miami, FL, 6SKiN Centre for Dermatology, Peterborough, ON, Canada, 7Janssen Services, LLC, Horsham, PA, 8Janssen Services, LLC, Spring House, PA, 9Janssen Research and Development, LLC, Spring House, PA, 10Janssen-Cilag, Beerse, Belgium, 11Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, VA

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Biologics, psoriasis and psoriatic arthritis

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Session Information

Title: Spondyloarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment II

Session Type: Abstract Submissions (ACR)

Background/Purpose We evaluated persistency (treatment longevity) of biologics in patients (pts) with psoriasis (PsO), as well as with psoriatic arthritis (PsA) in the context of a large disease-based registry.

Methods PSOLAR evaluates safety and clinical outcomes for PsO pts eligible to receive treatment with systemic agents. The study includes 36% pts (n=4317) with self-reported PsA. Duration of therapy was defined as time (in days) between first dose of biologic and the first of: 1) discontinuation 2) switch 3) registry withdrawal or 4) last database cutoff ( August 23, 2013). Separate analyses were performed for: 1st line (bio-naïve; i.e. first biologic started on registry), 2nd line (second biologic started while on registry) and 3rdline usage (third biologic started while on registry) to reduce confounding associated with prior exposures for overall population and for subset with PsA. Baseline demographics and reasons for stop/switch were summarized. Persistence was assessed by Kaplan-Meier (KM) analysis for time to therapy stop/switch separately for ustekinumab (UST), infliximab (IFX), adalimumab (ADA), and etanercept (ETN). Cox proportional hazard regression was used to compare time to stop/switch of UST with time to stop/switch of other biologics for each cohort.

Results The highest starts were attributed to UST (1833 pts) and ADA (1303) with lower starts for ETN (537) and IFX (327). Among UST starts, the proportions of 1st, 2nd and 3rd line usage were 20%, 31%, and 30%; ADA starts 31%, 48%, and 15%; ETN starts 54%, 29% and 13%; IFX starts 19%, 28% and 32%, respectively. Baseline clinical characteristics were generally comparable across biologics and cohorts, with some variability: prevalence of severe PsO was greater for UST and IFX vs ADA and ETN (higher BSA and higher proportions of pts with PGA score of 4 and 5). Fewer pts discontinued UST than IFX, ETN, and ADA in all 3 lines. Overall, median duration of therapy was generally longer for UST vs the 3 anti-TNF therapies. For first line starts, a better persistence was observed for UST based on statistically significant differences in time to stop/switch for each biologic vs UST (IFX vs UST: HR3.04; CI:1.66-5.57; p=0.0003; ADA vs UST: HR4.99; CI:3.39-7.35; p<0.0001; ETN vs UST: HR5.59; CI:3.77-8.29; p<0.0001). Similar results were observed for analysis of 2nd and 3rd line starts. In the subgroup with self-reported PsA, for first line starts, better persistence was observed with UST vs ETN (HR 2.53; CI 1.39-4.62; p=0.0024) but there were no significant differences vs IFX and ADA. UST had better persistence than all 3 anti-TNFs in the analyses of 2nd and 3rdline starts. Reasons for stop/switch were similar across biologics and cohorts (most frequent reason-lack of efficacy).  Data were not adjusted for expected variability such as socioeconomic factors (eg, access to medication), setting of administration (self vs HCP office, e.g, UST was likely often administered in a HCP office which may affect persistency), and geographic region.

Conclusion Persistence of UST therapy in psoriatic disease was significantly better than anti-TNF therapies in biologic- naïve and experienced PsO pts, with lower rates of stopping/switching and higher median days on therapy.


Disclosure:

A. Menter,

Janssen Scientific Affairs, LLC,

2;

K. Papp,

Janssen Scientific Affairs, LLC,

2;

G. G. Krueger,
None;

M. Augustin,

Janssen Scientific Affairs, LLC,

2;

F. Kerdel,

Janssen Scientific Affairs, LLC,

2;

M. Gooderham,

AbbVie, Allergan, Celgene, Eli Lilly, Galderma, Kythera, Leo Pharma, Merck, Novartis, and Pfizer,

9,

AbbVie, Amgen, Astellas, Galderma, Janssen, Leo Pharma, Novartis, and Pfizer,

8;

K. Goyal,

Janssen Scientific Affairs, LLC,

3;

S. Fakharzadeh,

Janssen Scientific Affairs, LLC,

3;

W. Langholff,

Janssen Scientific Affairs, LLC,

3;

J. Sermon,

Janssen Cilag,

3;

S. Calabro,

Janssen Scientific Affairs, LLC,

3;

D. Pariser,

Janssen Scientific Affairs, LLC,

2.

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