Atopic Dermatitis in the BIOREP Registry
Authors:
M. Kojanová 1; J. Fialová 1; P. Cetkovská 3; S. Gkalpakiotis 2; J. Štork 1; A. Machovcová 4; T. Doležal 5; D. Štrosová 5; Skupina Biorep-Ad
Authors‘ workplace:
Dermatovenerologická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. Jiří Štork, CSc.
1; Dermatovenerologická klinika 3. LF UK a FNKV, Praha, přednosta prof. MUDr. Petr Arenberger, DrSc., MBA, FCMA
2; Dermatovenerologická klinika FN a LF UK, Plzeň, přednosta prof. MUDr. Karel Pizinger, CSc.
3; Dermatovenerologické oddělení FN v Motole, Praha, primář MUDr. Alena Machovcová, Ph. D., MBA
4; Value Outcomes, Praha
5
Published in:
Čes-slov Derm, 96, 2021, No. 3, p. 134-141
Category:
Pharmacologyand Therapy, Clinical Trials
Overview
Background and objectives: The evaluation of patients with atopic dermatitis in the BIOREP registry in the Czech Republic.
Methods: A retrospective evaluation of patients with atopic dermatitis treated with dupilumab enrolled in the BIOREP registry was performed to date 21st May 2021.
Results: A total of 219 patients with atopic dermatitis were registered in the BIOREP registry, 53.9% were men and 46.1% were women. The average patient age was 39.5 years and 38.4 years at the start of biological treatment. The mean time from diagnosis to the initiation of biological treatment was 33.8 years. The most common comorbidities were allergic rhinitis in 67.1% of patients, food allergies in 56.6% and allergic asthma in 53.0% of patients. Eye involvement was observed in 29.2% of patients. From the other evaluated comorbidities, at least one occurred in more than half of the analyzed patients (53.4%), the most common disorders were metabolic/endocrine (19.6%), cardiovascular (15.1%), and psychiatric diseases (6.8%). At the start of treatment, the mean EASI was 33.2 and DLQI was 19.2. Patients are treated with dupilumab for an average of 10.3 months. The 50% improvement in EASI was achieved by 95.7% of patients after 3 months of treatment, 98.3% after 6 months and 100% after 12 and 18 months of treatment. At the same time, the 75% improvement in EASI was achieved by 68.3%; 93.4%; 93.8% and 97.0% of patients, respectively. During the treatment there was a significant improvement in the quality of life of patients, after 3 months of treatment the DLQI value decreased from the original 19.2 to 4.9. After 6 and 18 months of treatment, the value further decreased to 3.5 and 1.9 respectively.
Conclusion: BIOREP, as one of the oldest registries for biological/targeted therapy in dermatology, included patients with atopic dermatitis (BIOREP-AD) in 2020. The presented data complete the lacking information from real clinical practice and confirm the long duration of atopic dermatitis with the negative impact on a quality of life, the frequent association with comorbidities, the long period of previous insufficient treatment and the successful use of dupilumab.
Keywords:
atopic dermatitis – biological therapy – registries – dupilumab – BIOREP
Sources
1. ARIËNS, L. F. M., van der SCHAFT, J., BAKKER, D. S. et al. Dupilumab is very effective in a large cohort of difficult-to-treat adult atopic dermatitis patients: First clinical and biomarker results from the BioDay registry. Allergy, 2020, 1, p. 116–126.
2. ARIËNS, L. F. M., van der SCHAFT, J., SPEKHORST, L. S. et al. Dupilumab shows long-term effectiveness in a large cohort of treatment-refractory atopic dermatitis patients in daily practice: 52-Week results from the Dutch BioDay registry. J Am Acad Dermatol, 2021, 4, p. 1000–1009.
3. BOSMA, A. L., de WIJS, L. E. M., HOF, M. H. et al. Long--term effectiveness and safety of treatment with dupilumab in patients with atopic dermatitis: Results of the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry. J Am Acad Dermatol, 2020, 5, p. 1375–1384.
4. D´ERME, A. M., ROMANELLI, M., CHIRICOZZI, A. Spotlight on dupilumab in the treatment of atopic dermatitis: design, development, and potential place in therapy. Drug Des, Devel Ther, 2017, 11, p. 1473–1480.
5. DRUCKER, A. M., ELLIS, A. G., BOHDANOWICZ, M. et al. Systemic Immunomodulatory Treatments for Patients With Atopic Dermatitis: A Systematic Review and Network Meta-analysis. JAMA Dermatol, 2020, 6, p. 659–667.
6. HALLING, A. S., LOFT, N., SILVERBERG, J. I. et al. Real-world evidence of dupilumab efficacy and risk of adverse events: A systematic review and meta-analysis. J Am Acad Dermatol, 2021, 1, p. 139–147.
7. KANWAR, A. J. Adult-onset Atopic Dermatitis. Indian J Dermatol, 2016, 61, p. 662–663.
8. KATOH, N., SAEKI, H., KATAOKA, Y. et al. Atopic dermatitis disease registry in Japanese adult patients with moderate to severe atopic dermatitis (ADD-RESS-J): Baseline characteristics, treatment history and disease burden. J Dermatol, 2019, 4, p. 290–300.
9. KOJANOVÁ, M., FIALOVÁ, J., GKALPAKIOTIS, S. et al. Registr biologické/cílené léčby BIOREP - Souhrnná zpráva za rok 2020. Čes-slov Derm, 2021, 1, p. 17–34.
10. KOJANOVÁ, M., FIALOVÁ, J., CETKOVSKÁ, P. et al. Účinnost biologické léčby středně těžké až těžké psoriázy – analýza z registru BIOREP. Čes-slov Derm, 2021, 2, p. 73–79.
11. KOJANOVA, M., CETKOVSKA, P., STROSOVA, D. et al. Real-World Evidence From More Than 1000 Pa-tients Treated With Adalimumab For Moderate-to-Severe Psoriasis in the Czech Republic. Dermatol Ther (Heidelb), 2021, 2, p. 543–553.
12. KOJANOVA, M., FIALOVA, J., CETKOVSKA, P. et al. Demographic data, comorbidities, quality of life, and survival probability of biologic therapy associated with sex-specific differences in psoriasis in the Czech Republic. Dermatol Ther, 2021, 2, e14849.
13. LESHEM, Y. A., HAJAR, T., HANIFIN, J. M. et al. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol, 2015, 5, p. 1353–1357.
14. NUTTEN, S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann NutrMetab, 2015, 66, p. 8–16.
15. RODRIGUES, M. A., NOGUEIRA, M., TORRES, T. Dupilumab for atopic dermatitis: evidence to date. G Ital Dermatol Venereol, 2019, 6, p. 696–713.
16. SPEKHORST, L. S., ARIËNS, L. F. M., van der SCHAFT, J. et al. Two-year drug survival of dupilumab in a large cohort of difficult-to-treat adult atopic dermatitis patients compared to cyclosporine A and methotrexate: Results from the BioDay registry. Allergy, 2020, 9, p. 2376–2379.
17. Státní ústav pro kontrolu léčiv. (online) (cit. 20.5.2021). Dostupné na www: https://www.sukl.cz/modules/medication/detail.php?code=0222565&tab=prices.
18. WOLLENBERG, A., BARBAROT, S., BIEBER, T. et al. European Dermatology Forum (EDF), the European Academy of Dermatology and Venereology (EADV), European Academy of Allergy and Clinical Immunology (EAACI), European Task Force on Atopic Dermatitis (ETFAD), European Federation of Allergy and Airways Diseases Patients’ Associa-tions (EFA), European Society for Dermatology and Psychiatry (ESDaP), European Society of Pedia-tric Dermatology (ESPD), Global Allergy and As-thma European Network (GA2LEN) and European Union of Medical Specialists (UEMS). Consensus--based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II. J Eur Acad Dermatol, Venereol., 2018, 32, p. 850–878.
Labels
Dermatology & STDs Paediatric dermatology & STDsArticle was published in
Czech-Slovak Dermatology
2021 Issue 3
Most read in this issue
- Vasculitis from the Perspective of a Dermatologist
- The Comparison of Hospitalization Records of Patients with Syphilis in 2007–2009 and 2017–2019
- Atopic Dermatitis in the BIOREP Registry
- Multiple Rough Papules with Positive Auspitz’s Sign – Morbus Flegel. Minireview.