Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest.

K Reich,M Augustin,M A Radtke,U Mrowietz,D Thaci,C Spehr,S J Rustenbach

doi:10.1007/s00403-015-1593-8

Abstract

The German Psoriasis Registry PsoBest was conducted in 2008 in order to investigate the long-term outcomes and safety of systemic treatments for moderate-to-severe psoriasis. Safety analysis of antipsoriatic drugs with special focus on serious adverse events (SAE) for infections, malignancies and major cardiac events (MACE) was done. Nationwide non-interventional patient treatment registry conducted in 251 active dermatology centers. Until June 2012, n = 2444 patients [40 % female; mean age 47.3 (SD 14.1) years; mean duration of disease 18.2 (SD 14.7) years] were recruited, including n = 1791 patients (3842 patient years) with conventional systemic drugs and n = 908 (3442 patient years) with biological drugs. Mean PASI (Psoriasis Area and Severity Index) at inclusion was 14.7, mean DLQI (Dermatology Life Quality Index) 11.1, mean BMI (Body Mass Index) 28.2. The overall rate of SAE per 100 patient years were 1.3 (SD 0.9) per 100 patient years in conventional systemic and 1.5 (SD 1.2) in biologics (p > 0.5, no significant difference). The rates per 100 patient years for single severe adverse events were as follows (systemic/biologics): serious infections, 0.33/0.65 [CI (confidence interval) 0.13–0.54/0.35–0.98]; MACE, 0.56/0.77 (CI 0.29–0.97/0.41–1.31); malignancies (except non-melanoma skin cancer), 0.46/0.49 (CI 0.22–0.84/0.21–0.97). There were no significant differences between single drugs in any of the safety parameters. The conventional systemic and biologic drugs for psoriasis show satisfying safety under routine psoriasis care in Germany with respect to infections, MACE and malignancies.

Highlights

According to evidence-based guidelines, systemic drugs are treatments of choice for patients with moderate-tosevere psoriasis [13, 16]
First-line systemic treatment includes methotrexate, ciclosporin A and retinoids, whereas the second-line treatment is based on the biologics infliximab, etanercept, ustekinumab and adalimumab for plaque type psoriasis and psoriatic arthritis, and golimumab for psoriatic arthritis
Patients with moderate or severe psoriasis are included in PsoBest, when treatment with a conventional systemic agent or biologic is started for the first time

Summary

Introduction

According to evidence-based guidelines, systemic drugs are treatments of choice for patients with moderate-tosevere psoriasis [13, 16]. First-line systemic treatment includes methotrexate, ciclosporin A and retinoids, whereas the second-line treatment is based on the biologics infliximab, etanercept, ustekinumab and adalimumab for plaque type psoriasis and psoriatic arthritis, and golimumab for psoriatic arthritis. In Germany fumaric acid esters (FAE) are licensed for first-line treatment. Showing a chronic, persisting course of disease, psoriasis requires a long-term strategy for treatment over many decades [2, 3]. The German Psoriasis Registry PsoBest records safety, long-term efficacy, patient benefit and treatment regimens of psoriasis. Patients with moderate or severe psoriasis are included in PsoBest, when treatment with a conventional systemic agent or biologic is started for the first time.

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Conclusion