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

Jan Hugo; Martina Kojanova; Barbora Turkova; Spyridon Gkalpakiotis; BIOREP Study Group

doi:10.1007/s13555-023-00893-4

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

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

Authors

Jan Hugo¹, Martina Kojanova², Barbora Turkova³, Spyridon Gkalpakiotis⁴; BIOREP Study Group

Collaborators

BIOREP Study Group:
Zdenek Antal, Petr Arenberger, Jirina Bartonová, Linda Blahova, Petra Brodska, Petr Bohac, Hana Buckova, Martin Cetkovsky, Petra Cetkovska, Jana Cadova, Dominika Diamantova, Magdalena Dobiasova, Hana Duchkova, Jorga Fialova, Olga Filipovska, Jana Földesova, Petra Gkalpakioti, Martina Grycova, Jiri Horazdovsky, Eva Horka, Katerina Hrazdirova, Eduard Hrncir, Jana Chlebkova, Jaromira Janku, Lucie Jaresova, Renata Kopova, Dora Kovandova, Silvie Krchova, Lenka Kulmanova, Natalie Kunesova, Iva Lomicova, Romana Machackova, Alena Machovcova, Hana Malikova, Martina Matzenauer, Miroslav Necas, Helena Nemcova, Radka Neumannova, Michaela Novakova, Jitka Osmerova, Veronika Pallova, Lucie Petru, Blanka Pinkova, Zuzana Plzakova, Marie Policarova, Tomas Pospisil, Filip Rob, Miloslav Salavec, Marie Selerova, Veronika Slonkova, Jiri Strok, Ivana Strouhalova, David Stuchlik, Alena Stumpfova, Jaroslav Sevcik, Jan Sternbersky, Katerina Svarcova, Katerina Tepla, Martin Tichy, Hana Tomkova, Yvetta Vantuchova, Ivana Vejrova, Iva Zampachova

Affiliations

¹ Department of Dermatovenereology, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic. jan.hugo@fnkv.cz.
² Department of Dermatovenereology, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic.
³ Value Outcomes, Prague, Czech Republic.
⁴ Department of Dermatovenereology, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.

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.