Persistence of Treatment With Biologics for Patients With Psoriasis

A Real-World Analysis of 16,545 Biologic-Naive Patients From the French National Health Insurance Database (SNIIRAM)

E. Sbidian; M. Mezzarobba; A. Weill; J. Coste; J. Rudant

Disclosures

The British Journal of Dermatology. 2019;180(1):86-93. 

In This Article

Abstract and Introduction

Abstract

Background: Long-term clinical effectiveness of biologics in psoriasis is needed.

Objectives: We aimed to assess the long-term persistence of biologics used to treat psoriasis in a real-life setting.

Methods: All adults with psoriasis having been registered in the French National Health Insurance database (SNIIRAM) between 2008 and 2016 were eligible for inclusion. Psoriasis was defined as the fulfilment of at least two prescriptions for topical formulations of a vitamin D derivative within a 2-year period. The study population comprised biologic-naïve patients, i.e. those with a first prescription of etanercept, infliximab, adalimumab or ustekinumab. Persistence of treatment with a biologic was defined as the time interval between initiation and discontinuation.

Results: In this nationwide population-based cohort, 16 545 out of 874 549 patients with psoriasis were biologic-naïve (mean age 48·6 years; males 57·3%, mean follow-up 3·6 years). The mean ± SD length of follow-up for biologic-naïve patients was 3·6 ± 2·4 years. There were 9988 treatment discontinuations. Kaplan–Meier survival analyses revealed a persistence rate of 61·9% for the first, 33·3% for the third and 22·6% for the fifth year. Ustekinumab had a higher persistence rate than the other biologics. This finding should be interpreted with caution, in view of differences in administration between the biologics. About 85% of patients, having discontinued their first biologic, resumed systemic treatment of some type in the following year (biologics in 85% of cases).

Conclusions: Our data suggest that biologics are less effective than physicians have been led to believe in a real-life, nonselected population. Further, long-term disease control requires several courses of different biologics.

Introduction

Over the past two decades, a better pathophysiological understanding of psoriasis has led to the identification of new drug targets and the development of biologics.[1] A recent Cochrane review has found that biologics are more efficacious than conventional, systemically administered drugs (such as methotrexate or ciclosporin) in a selected population of patients with moderate-to-severe psoriasis.[2] However, the evidence is limited to the induction phase (from 12 to 16 weeks) and is not sufficiently relevant to chronic disease. Nast et al. performed a network meta-analysis of trials in which treatments were assessment for at least 24 weeks.[3] Interestingly, the efficacy levels of biologics were maintained over time. However, this finding still corresponds to a relatively short-term time frame (24 weeks) for a disease that can persist for many years. Moreover, clinical trial participants are subject to inclusion and noninclusion biases (becoming increasingly stringent), which limits the ability to extrapolate trial results.[4–6] Therefore, although biologics appear to be highly effective for inducing short-term remission in a selected population of patients with psoriasis, there is much less evidence of the long-term clinical effectiveness of biologics in this setting.

Treatment persistence (defined as the time interval between treatment initiation and discontinuation) is a relevant indicator of the patient's level of interest.[7] This parameter integrates effectiveness (because a treatment perceived as being ineffective will not be continued) and safety (because a poorly tolerated treatment is likely to be discontinued). Persistence is similar to the judgement criteria typically applied in pragmatic trials.[8] This parameter is attracting growing interest in the field of dermatology, where most studies have looked at the persistence of treatment with biologics in patients suffering from psoriasis.[9–13] However, these studies were limited by selective recruitment of the study population (in a postmarketing commitment study[12]) or the small number of enrolled patients.[10,11,13]

The main objective of the present study was therefore to assess and compare the long-term persistence of several different biologics used to treat psoriasis in a large, exhaustive, nonselected population of patients in France. This study was approved by the French data protection agency Commission Nationale de l'Informatique et des Libertés (regulatory decision DE-2015-165).

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