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. 2023 Mar;13(3):787-801.
doi: 10.1007/s13555-023-00893-4. Epub 2023 Feb 1.

Long-Term Efficacy, Safety, and Drug Survival of Guselkumab in Patients with Psoriasis: Real-World Data from the Czech Republic BIOREP Registry

Jan Hugo  1 , Martina Kojanova  2 , Barbora Turkova  3 , Spyridon Gkalpakiotis  4 ; BIOREP Study Group
Collaborators, Affiliations

Long-Term Efficacy, Safety, and Drug Survival of Guselkumab in Patients with Psoriasis: Real-World Data from the Czech Republic BIOREP Registry

Jan Hugo et al. Dermatol Ther (Heidelb). 2023 Mar.

Abstract

Background: Real-world data on the long-term use of guselkumab for treatment of psoriasis are still limited.

Objective: We aimed to evaluate long-term efficacy, safety, and drug survival of guselkumab in a real-world setting.

Methods: This is a retrospective study analyzing Czech Republic registry (BIOREP) data of patients treated with guselkumab.

Results: In total, 333 patients were included. Improvement in Psoriasis Area and Severity Index (PASI) score was significant. Mean PASI score decreased from 16 at baseline to 0.7, 0.9, and 0.8 after 12, 24, and 36 months, respectively. Absolute PASI scores of ≤ 3 and ≤ 1 were achieved in 93.9% and 77.9%, 94.2% and 71.0%, and 94.8% and 70.7% of patients after 12, 24, and 36 months, respectively. Response PASI 90 and PASI 100 were attained in 81.8% and 57.1%, 75.4% and 50.7%, and 75.9% and 55.2% of patients after 12, 24, and 36 months, respectively. The percentage of patients achieving PASI 90 and PASI 100 responses was higher throughout the study in bio-naive and in normal-weight patients, while presence of psoriatic arthritis had no influence. Improvement in Dermatology Life Quality Index (DLQI) score was also significant; mean DLQI score decreased from 14.2 at baseline to 0.9, 1.0, and 0.7 after 12, 24, and 36 months, respectively. Patients with PASI 100 had lower mean DLQI throughout the study compared with patients with PASI 90. Major reason for discontinuation was loss of effectiveness in 7.1% of patients, while only 0.6% were due to adverse events. Overall cumulative drug survival was high, with only a minimal decline over time, reaching 91.6%, 87.0%, and 85.5% after 12, 24, and 36 months, respectively. Drug survival was not affected by previous biological treatment, patient weight, or presence of psoriatic arthritis.

Conclusions: This real-world study demonstrated the long-term effectiveness, good safety profile, and high drug survival of guselkumab treatment over a period of 36 months.

Keywords: BIOREP; Biological therapy; Guselkumab; Psoriasis; Real world; Registries.

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Figures

Fig. 1
Fig. 1
Changes in mean PASI score
Fig. 2
Fig. 2
Percentage of patients achieving PASI ≤ 3 and ≤ 1
Fig. 3
Fig. 3
Development in improvement in PASI score in category of PASI 90 and PASI 100
Fig. 4
Fig. 4
Achievement of PASI 90 and PASI 100 a in bio-naive and bio-experienced patients; b in patients with BMI under 25 kg/m2 and over 25 kg/m2; c in patients with and without PsA
Fig. 5
Fig. 5
Mean DLQI a all patients; b in the PASI 90 and PASI 100 category
Fig. 6
Fig. 6
Drug survival in: a all patients; b by bio-naivety; c by presence of psoriatic arthritis; d by BMI
See this image and copyright information in PMC

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