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Registry of Biological/ Targeted Therapy BIOREP – Summary Report 2023


Authors: M. Kojanová 1;  J. Fialová 1;  P. Cetkovská 2;  S. Gkalpakiotis 3;  A. Machovcová 4;  J. Štork 1;  P. Arenberger 3;  T. Doležal 5;  B. Turková 5;  Biorep Skupina
Authors place of work: Dermatovenerologická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. Jiří Štork, CSc. 1;  Dermatovenerologická klinika FN a LF UK, Plzeň, přednosta MUDr. Jan Říčař Ph. D. 2;  Dermatovenerologická klinika 3. LF UK a FNKV, Praha, přednosta prof. MUDr. Petr Arenberger, DrSc., MBA 3;  Dermatovenerologické oddělení FN v Motole, Praha, primář MUDr. Alena Machovcová, Ph. D., MBA 4;  Value Outcomes, Praha 5
Published in the journal: Čes-slov Derm, 99, 2024, No. 2, p. 62-86
Category: Pharmacologyand Therapy, Clinical Trials

Summary

Background and objectives: Evaluation of patients included in the registry of biological/targeted therapy BIOREP in the Czech Republic.

Methods: A retrospective evaluation of patients to date 31 December 2023 enrolled in the BIOREP registry was performed. The aim of our study was to evaluate patients on biological/targeted treatment in the given period in individual categories and to analyze the population of patients with psoriasis, hidradenitis suppurativa and atopic dermatitis. In the case of categorical variables, the results were expressed using number and percentage. Continuous variables were described using count, mean, standard deviation, median, minimum, and maximum Results: As of 31 December 2023, a total of 6,676 patients were registered in the BIOREP registry: 4,763 (71.3%) patients with psoriasis, 538 (8.1%) with hidradenitis, 1,346 (20.2%) with atopic dermatitis and 29 (0.4%) were treated off label with targeted treatment. Of the psoriasis group, 62.5% of patients were men. The average patient age at the end of 2023 was 52.3 years, the mean age at the time of diagnosis was 25.6 years, and the age at first biological/targeted treatment was 46.4 years. In 2023, the average time from diagnosis to the introduction of targeted treatment was 20.8 years, the average duration of biological/targeted treatment was 5.2 years. The comorbidities occurred in 70.6% of patients. The most common disorder were metabolic/endocrine diseases (39.2%) and cardiovascular diseases (37.8%). From the individual comorbidities, hypertension (35.2%), dyslipidemia (26.5%) and diabetes mellitus (12.5%) were the most common. A total of 76.1% of patients were overweight or obese and 33% of patients were smokers. Psoriatic arthritis was observed in 30.8% of patients. At the start of treatment and at the last visit, the mean PASI was 18.6 and 1.8, respectively, the mean BSA 29% and 2.5%, respectively and DLQI 16.1 and 1.6, respectively. After 12 months of treatment, a total of 91.8%; 82.6%; 64.7% and 40.8% of patients achieved PASI50, PASI75, PASI90 and PASI100, respectively. In 2023, a total of 645 patients newly started treatment and at the end of year 2023, a total of 4.120 patients were treated, the most patients used Skyrizi (15.7%), Humira (12.1%) and Cosentyx (12%). As of 31 December 2023, there were a total of 538 patients with hidradenitis suppurativa in the registry of mean age 44.5 years and 55.4% were men. The mean age at the time of diagnosis was 32.7 years and the age at first biological treatment was 41,7 years. The average time from diagnosis to the start of the biological treatment was 9 years and patients were treated for an average of 2.7 years. In 2023, a total of 85 patients started the biological treatment. At the end of 2023, a total of 422 patients were treated and the average duration of treatment was 2.4 years, the most common medication was Humira (67.8%). At the end of 2023, there were a total of 1,346 patients with atopic dermatitis in the registry of mean age 36.2 years, 51% were men. The mean age at the time of diagnosis was 5.2 years and the age at first targeted treatment was 34.9 years. The average time from diagnosis to the start of the targeted treatment was 29.8 years and patients were treated for an average of 1.7 years. A total of 60.1% of patients had concomitant allergic rhinitis, 54.8% food allergy and 42.1% allergic asthma. Ocular comorbidities occurred in 23.6% of patients, the most common were atopic conjunctivitis (12.2%). At the start of treatment and at the last visit, the mean EASI was 30.8 and 4.1, respectively, mean BSA was 56% and 8%, respectively, and mean DLQI 18.2 and 3.7 respectively. In 2023, a total of 496 patients started the biological treatment. At the end of 2023, a total of 1,239 patients were treated and the average duration of treatment was 1.6 years, the most common medication was Dupixent (81%).

Conclusion: The analysis confirmed the high activity of diseases according to objective evaluation and the significant negative impact on the quality of life before initiation of targeted treatment, with a decrease in the evaluated scores during treatment. At the same time, it demonstrates a high prevalence of comorbidities and risk factors and a long diseases duration before the introduction of targeted treatment.

Keywords:

psoriasis – Hidradenitis suppurativa – atopic dermatitis – biological therapy – targeted therapy – registries – BIOREP


Zdroje
  1. BIOREP. Dostupné na www: www.biorep.cz, (přístupno 2.2.2024).
  2. HUGO, J., KOJANOVA, M., TURKOVA, B., GKALPAKIOTIS, S., BIOREP STUDY GROUP. 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; 13(3), p. 787–801.
  3. KOJANOVÁ, M., CETKOVSKÁ, P., GKALPAKIOTIS, S., FIALOVÁ, J., MACHOVCOVÁ, A., ŠTORK, J., ARENBERGER, P., DOLEŽAL, T., TURKOVÁ, B., SKUPINA BIOREP. BIOREP – registr biologické/cílené léčby: Souhrnná zpráva za rok 2022. Čes-slov Derm, 2023; 2, p. 45–120.
  4. KOJANOVA, M., HUGO, J., VELACKOVA, B., CETKOVSKA, P., FIALOVA, J., DOLEZAL, T., TICHY, M., GKALPAKIOTIS, S., BIOREP STUDY GROUP. Efficacy, safety, and drug survival of patients with psoriasis treated with IL-17 inhibitors – brodalumab, ixekizumab, and secukinumab: real-world data from the Czech Republic BIOREP registry. J Dermatolog Treat, 2022; 33(6), p. 2827–2837.
  5. KOJANOVA, M., TANCZOSOVA, M., STROSOVA, D., CETKOVSKA, P., FIALOVA, J., DOLEZAL, T., MACHOVCOVA, A., GKALPAKIOTIS, S., BIOREP STUDY GROUP. Dupilumab for the treatment of atopic dermatitis: real-world data from the Czech Republic BIOREP registry. J Dermatolog Treat, 2022; 33(5), p. 2578–2586.
  6. SMETANOVA, A., MARQUES, E., KOJANOVA, M., ARENBERGER, P., STROSOVA, D., FIALOVA, J., ARENBERGEROVA. M. Employing Adalimumab in Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Real-Life Multicenter Data from the Czech Republic. Dermatol Ther, 2023; 15, p. 1–8.
  7. TICHY, M., KOJANOVA, M., VELACKOVA, B., DOLEZAL, T., GKALPATIOTIS, S., CETKOVSKA, P., BIOREP STUDY GROUP. Efficacy of switches within the class of IL‐17 inhibitors: An analysis of data from the Czech nationwide registry of psoriatic patients receiving biological/targeted therapy (BIOREP). Dermatol Ther, 2022; 35(10):e15772.

Poděkování

Autoři děkují všem zúčastněným dermatologům a spolupracovníkům, kteří se podílejí na registru BIOREP, za jejich úsilí a obětavost.

Skupina BIOREP: Zdeněk Antal, Jiřina Bartoňová, Alžbeta Bezvodová, Linda Bláhová, Petr Boháč, Hana Bučková, Martin Cetkovský, Jana Čadová, Dominika Diamantová, Magdaléna Dobiášová, Zdenka Durďáková, Olga Filipovská, Jana Földesová, Petra Gkalpakioti, Martina Grycová, Klára Honzíková, Jiří Horažďovský, Eva Horká, Kateřina Hrazdírová, Eduard Hrnčíř, Jana Chlebková, Jaromíra Janků, Lucie Jarešová, Renata Kopová, Silvie Krchová, Lenka Kulmanová, Natálie Kunešová, Iva Lomicová, Romana Macháčková, Hana Malíková, Martina Matzenauer, Lukáš Meričko, Miroslav Nečas, Helena Němcová, Radka Neumannová, Michaela Nováková, Jitka Ošmerová, Veronika Pallová, Lucie Petrů, Blanka Pinkova, Zuzana Plzáková, Marie Policarová, Tomáš Pospíšil, Filip Rob, Marcela Rozkošová, Jan Říčař, Miloslav Salavec, Marie Selerová, Kristýna Sladkovská, Veronika Slonková, Ivana Strouhalová, David Stuchlík, Alena Stumpfová, Jaroslav Ševčík, Jan Šternberský, Kateřina Švarcová, Kateřina Teplá, Martin Tichý, Hana Tomková, Iveta Tomšíková, Yvetta Vantuchová, Michaela Vaverková, Ivana Vejrová, Iva Žampachová.

Komise pro BIOREP: Petr Arenberger (garant), Martina Kojanová (koordinátor), Petra Cetkovská, Spyridon Gkalpakiotis, Jorga Fialová, Alena Machovcová, Jiří Štork.

Do redakce došlo dne 6. 2. 2024.

Adresa pro korespondenci:
MUDr. Martina Kojanová, Ph.D.
Dermatovenerologická klinika 1. LF UK a VFN
U Nemocnice 2
120 00 Praha 2
e-mail:
kojanova.martina@vfn.cz

Štítky
Dermatology & STDs Paediatric dermatology & STDs
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