Drug survival of biologic therapy in a large, disease‐based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)

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Abstract

Background

Drug survival is a marker for treatment sustainability in chronic diseases such as psoriasis.

Objective

The aim of these analyses was to assess survival of biologic treatments in the PSOriasis Longitudinal Assessment and Registry ( PSOLAR).

Methods

PSOLAR is a large, prospective, international, disease‐based registry of patients with psoriasis receiving (or eligible for) systemic therapy in a real‐world setting. Drug survival is defined as the time from initiation to discontinuation (stop/switch) of biologic therapy on registry. The number of patients who discontinued each treatment and the duration of therapy were recorded. Using Kaplan–Meier survival curves and Cox‐regression analyses [hazard ratios ( HR) and 95% confidence intervals ( CIs)], time to discontinuation was compared across cohorts undergoing first‐, second‐ or third‐line treatment with ustekinumab, infliximab, adalimumab or etanercept.

Results

As of the 2013 data cut, 12 095 patients with psoriasis were enrolled in PSOLAR. Of the 4000 patients initiating any new biologic therapy, approximately 3500 started a first‐line, second‐line or third‐line biologic therapy during the registry. Lack of effectiveness was the most common reason for discontinuation across biologic therapies. Based on the multivariate analysis, significantly shorter times to discontinuation were observed for infliximab [ HR (95% CI) = 2.73 (1.48 –5.04), P = 0.0014]; adalimumab [4.16 (2.80 –6.20), P < 0.0001]; and etanercept [4.91 (3.28 –7.35) P < 0.0001] compared with ustekinumab [reference treatment]) for first‐line biologic use; results were similar for treatment effects for second/third‐line therapies. Although limited in power, analyses in patients with concurrent psoriatic arthritis confirmed by a rheumatologist reflect observations in the overall psoriasis population.

Conclusion

Drug survival was superior for ustekinumab compared with infliximab, adalimumab and etanercept in patients with psoriasis.

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Most cited references 22

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Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial

Christopher Ritchlin, Proton Rahman, Arthur Kavanaugh … (2014)

Objective Assess ustekinumab efficacy (week 24/week 52) and safety (week 16/week 24/week 60) in patients with active psoriatic arthritis (PsA) despite treatment with conventional and/or biological anti-tumour necrosis factor (TNF) agents. Methods In this phase 3, multicentre, placebo-controlled trial, 312 adults with active PsA were randomised (stratified by site, weight (≤100 kg/>100 kg), methotrexate use) to ustekinumab 45 mg or 90 mg at week 0, week 4, q12 weeks or placebo at week 0, week 4, week 16 and crossover to ustekinumab 45 mg at week 24, week 28 and week 40. At week 16, patients with <5% improvement in tender/swollen joint counts entered blinded early escape (placebo→45 mg, 45 mg→90 mg, 90 mg→90 mg). The primary endpoint was ≥20% improvement in American College of Rheumatology (ACR20) criteria at week 24. Secondary endpoints included week 24 Health Assessment Questionnaire-Disability Index (HAQ-DI) improvement, ACR50, ACR70 and ≥75% improvement in Psoriasis Area and Severity Index (PASI75). Efficacy was assessed in all patients, anti-TNF-naïve (n=132) patients and anti-TNF-experienced (n=180) patients. Results More ustekinumab-treated (43.8% combined) than placebo-treated (20.2%) patients achieved ACR20 at week 24 (p<0.001). Significant treatment differences were observed for week 24 HAQ-DI improvement (p<0.001), ACR50 (p≤0.05) and PASI75 (p<0.001); all benefits were sustained through week 52. Among patients previously treated with ≥1 TNF inhibitor, sustained ustekinumab efficacy was also observed (week 24 combined vs placebo: ACR20 35.6% vs 14.5%, PASI75 47.1% vs 2.0%, median HAQ-DI change −0.13 vs 0.0; week 52 ustekinumab-treated: ACR20 38.9%, PASI75 43.4%, median HAQ-DI change −0.13). No unexpected adverse events were observed through week 60. Conclusions The interleukin-12/23 inhibitor ustekinumab (45/90 mg q12 weeks) yielded significant and sustained improvements in PsA signs/symptoms in a diverse population of patients with active PsA, including anti-TNF-experienced PsA patients.

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Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA)

P J Mease, R Fleischmann, A Deodhar … (2013)

Objectives To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-PsA (NCT01087788), an ongoing Phase 3 trial in patients with psoriatic arthritis (PsA). Methods Patients were randomised 1:1:1 to placebo, 200 mg CZP every 2 weeks (Q2W) or 400 mg CZP every 4 weeks (Q4W). Patients could have had exposure to one previous tumour necrosis factor (TNF) inhibitor therapy. Primary endpoints were American College of Rheumatology 20% (ACR20) response at week 12 and modified Total Sharp Score change from baseline at week 24. Secondary endpoints included; Psoriatic Arthritis Response Criteria (PsARC) score, Health Assessment Questionnaire Disability Index (HAQ-DI), Psoriasis Area and Severity Index, Leeds Enthesitis Index, Leeds Dactylitis Index, and Modified Nail Psoriasis Severity Index. Results Of 409 patients randomised, 368 completed 24 weeks of treatment. ACR20 response was significantly greater in CZP 200 mg Q2W and 400 mg Q4W-treated patients than placebo (58.0% and 51.9% vs 24.3% (p<0.001)) at week 12, with improvements observed by week 1. There was a statistically significant improvement in physical function from baseline, measured by HAQ-DI in CZP patients compared with placebo (−0.50 vs −0.19, p<0.001) and more patients treated with CZP 200 mg Q2W and CZP 400 mg achieved an improvement in PsARC at week 24 than placebo (78.3% and 77.0% vs 33.1% (p<0.001)). Sustained improvements were observed in psoriatic skin involvement, enthesitis, dactylitis and nail disease. Higher ACR20 response with CZP was independent of prior TNF inhibitor exposure. No new safety signals were observed. Conclusions Rapid improvements in the signs and symptoms of PsA, including joints, skin, enthesitis, dactylitis and nail disease were observed across both CZP dosing regimens.

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Differential Drug Survival of Biologic Therapies for the Treatment of Psoriasis: A Prospective Observational Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR).

Richard B Warren, Catherine H. Smith, Zenas Z N Yiu … (2015)

Drug survival reflects a drug's effectiveness, safety, and tolerability. We assessed the drug survival of biologics used to treat psoriasis in a prospective national pharmacovigilance cohort (British Association of Dermatologists Biologic Interventions Register (BADBIR)). The survival rates of the first course of biologics for 3,523 biologic-naive patients with chronic plaque psoriasis were compared using survival analysis techniques and predictors of discontinuation analyzed using a multivariate Cox proportional hazards model. Data for patients on adalimumab (n=1,879), etanercept (n=1,098), infliximab (n=96), and ustekinumab (n=450) were available. The overall survival rate in the first year was 77%, falling to 53% in the third year. Multivariate analysis showed that female gender (hazard ratio (HR) 1.22; 95% confidence interval (CI): 1.09-1.37), being a current smoker (HR 1.19; 95% CI: 1.03-1.38), and a higher baseline dermatology life quality index (HR 1.01; 95% CI: 1.00-1.02) were predictors of discontinuation. Presence of psoriatic arthritis (HR 0.82; 95% CI: 0.71-0.96) was a predictor for drug survival. As compared with adalimumab, patients on etanercept (HR 1.63; 95% CI: 1.45-1.84) or infliximab (HR 1.56; 95% CI: 1.16-2.09) were more likely to discontinue therapy, whereas patients on ustekinumab were more likely to persist (HR 0.48; 95% CI: 0.37-0.62). After accounting for relevant covariates, ustekinumab had the highest first-course drug survival. The results of this study will aid clinical decision making when choosing biologic therapy for psoriasis patients.

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Author and article information

Journal

Journal ID (nlm-ta): J Eur Acad Dermatol Venereol

Journal ID (iso-abbrev): J Eur Acad Dermatol Venereol

Journal ID (doi): 10.1111/(ISSN)1468-3083

Journal ID (publisher-id): JDV

Title: Journal of the European Academy of Dermatology and Venereology

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Print): 0926-9959

ISSN (Electronic): 1468-3083

Publication date (Electronic): 30 March 2016

Publication date (Print): July 2016

Volume: 30

Issue: 7 ( doiID: 10.1111/jdv.2016.30.issue-7 )

Pages: 1148-1158

Affiliations

[ ¹ ]Baylor University Medical Center Dallas TXUSA

[ ² ]K Papp Clinical Research and Probity Medical Research, Inc. Waterloo OntarioCanada

[ ³ ]SKIN Centre for Dermatology and Probity Medical Research Peterborough OntarioCanada

[ ⁴ ]Eastern Virginia Medical School and Virginia Clinical Research Norfolk VAUSA

[ ⁵ ]University Medical Center Hamburg‐Eppendorf HamburgGermany

[ ⁶ ]Florida Academic Dermatology Centers Miami FLUSA

[ ⁷ ] Janssen Scientific AffairsLLC Horsham PAUSA

[ ⁸ ] Janssen Research & DevelopmentLLC Horsham PAUSA

[ ⁹ ] Janssen Research & DevelopmentLLC Titusville NJUSA

[ ¹⁰ ]Janssen‐Cilag NV BeerseBelgium

[ ¹¹ ]University of Utah School of Medicine Salt Lake City UTUSA

Author notes

[*] [* ]Correspondence: A. Menter. E‐mail: amderm@ 123456gmail.com

Article

Publisher ID: JDV13611

DOI: 10.1111/jdv.13611

PMC ID: 5071685

PubMed ID: 27027388

SO-VID: b88f0950-ecd1-438f-8eba-0917eec92889

License:

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

History

Date revision received : 14 July 2015

Date accepted : 06 January 2016

Page count

Pages: 11

Funding

Funded by: Janssen Scientific Affairs, LLC, Horsham, PA, USA.

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component-id jdv13611

cover-date July 2016

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:4.9.5 mode:remove_FC converted:20.10.2016

Drug survival of biologic therapy in a large, disease‐based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)

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Abstract

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Karger: Dermatology

Most cited references 22

Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA)

Differential Drug Survival of Biologic Therapies for the Treatment of Psoriasis: A Prospective Observational Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR).

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