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. 2015 Dec;307(10):875-83.
doi: 10.1007/s00403-015-1593-8. Epub 2015 Sep 10.

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

K Reich  1 , U Mrowietz  2 , M A Radtke  3 , D Thaci  4 , S J Rustenbach  3 , C Spehr  3 , M Augustin  3
Affiliations

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

K Reich et al. Arch Dermatol Res. 2015 Dec.

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.

Keywords: Biologic treatment; Drug safety; Pharmacovigilance; Psoriasis; Registry; Systemic treatment.

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Figures

Fig. 1
Fig. 1
Rates for comorbidity in patients with psoriasis of the PsoBest registry compared to the age- and gender-adjusted rate of the German normal population (left graph) and comparison between patients started with biologics versus systemic (right graph; n = 2444)
Fig. 2
Fig. 2
Rates per 100 patient years of infections (non-severe, severe and serious) in psoriasis patients with systemic and biological drugs (n = 2444), bars show confidence interval
Fig. 3
Fig. 3
Rates per 100 patient years of MACE (major cardiac events) and other severe cardiovascular events in psoriasis patients with systemic and biological drugs (n = 2444), bars show confidence interval
Fig. 4
Fig. 4
Rates of malignancies in psoriasis patients with systemic and biological drugs, including all malignancies except non-melanoma skin cancer (top), non-melanoma skin cancer (middle), and melanoma skin cancer (bottom); n = 2444, bars show confidence interval
See this image and copyright information in PMC

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