Assessment of long-term safety and efficacy of Dupilumab therapy in patients with moderate-to-severe atopic dermatitis in the UAE: A real-life observational study
Main Article Content
Keywords
atopic dermatitis, dermatology, dupilumab, efficacy, safety, quality of life
Abstract
Background: Atopic Dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease characterized primarily scaly, pruritic, and erythematous skin lesions, all of which can have a profound negative impact on a patient’s quality of life. Dupilumab, is currently used for treating moderate-to-severe AD with promising efficacy and safety outcomes, however, limited data about long-term outcomes is available. Objective: To assess the long-term safety and efficacy of Dupilumab therapy, as well as the quality of life in patients with moderate-to-severe AD in the UAE. Methods: This retrospective observational study was conducted in Al-Qassimi and Tawam Hospitals, UAE. Patients’ data were extracted from the electronic medical records. Long-term efficacy and quality of life upon Dupilumab use were assessed by multiple validated assessment tools for patients with AD (SCORAD, EASI, DLQI/CDLQI, vIGA, and Pruritus NRS). The safety of therapy was also assessed through documented adverse events. The change in the scores of the assessment tools was determined by paired t-test and repeated measures ANOVA. Results: This study included 96 patients with moderate-to-severe AD from two hospitals in the UAE between 2019 and 2023, who were followed-up over 36 months (3 years). Mean age was 23.7±13.8 years old and nearly half of the patients were females (52.1%, n= 50). In the study sample, AD most commonly appeared on the upper (88.5%, n= 85), lower extremities (71.3%, n= 78), and head-neck region (77.1%, n= 74). There was a significant improvement in patients’ symptoms and quality of life, which was observed in SCORAD, EASI, DLQI/CDLQI, vIGA, and Pruritus-NRS scores (p<0.001) over three consequence years of receiving Dupilumab therapy (weeks 2,6,12,24,52,104, and 156). Dupilumab demonstrated considerable safety with few patients reporting side effects such as drowsiness, injection site reaction, flaring AD, and conjunctivitis. Conclusion: This study demonstrated that Dupilumab therapy was effective in the management of moderate-to-severe AD over long-term use and significantly improved patients’ quality of life with an acceptable safety profile among children and adults.
References
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14. Simpson E, Bissonnette R, Eichenfield LF, et al. The Validated Investigator Global Assessment for Atopic Dermatitis (vIGAAD): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis. Journal of the American Academy of Dermatology. 2020;83(3):839-46. https://doi.org/10.1016/j.jaad.2020.04.104
15. F A, J V, Ay F. Counting the Burden: Atopic Dermatitis and Health-related Quality of Life. Acta dermato-venereologica [Internet]. 2020 Jun 9 [cited 2022 Nov 14];100(12). Available from: https://pubmed.ncbi.nlm.nih.gov/32412644/
16. Basra MKA, Salek MS, Camilleri L, et al. Determining the Minimal Clinically Important Difference and Responsiveness of the Dermatology Life Quality Index (DLQI): Further Data. DRM. 2015;230(1):27-33. https://doi.org/10.1159/000365390
17. Yosipovitch G, Reaney M, Mastey V, et al. Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate‐to‐severe atopic dermatitis. Br J Dermatol. 2019;181(4):761-9. https://doi. org/10.1111/bjd.17744
18. Husein-ElAhmed H, Steinhoff M. Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. Journal of Dermatological Treatment. 2022 Apr 3;33(3):1547-53. https://doi.org/10.1080/095 46634.2020.1853024
19. Rathinam KK, Abraham JJ, Vijayakumar TM. Dupilumab in the Treatment of Moderate to Severe Asthma: An Evidence-Based Review. Curr Ther Res Clin Exp. 2019;91:45-51. https://pubmed.ncbi.nlm.nih.gov/31871508/
20. Cai S, Xu S, Lou H, et al. Comparison of Different Biologics for Treating Chronic Rhinosinusitis With Nasal Polyps: A Network Analysis. The Journal of Allergy and Clinical Immunology: In Practice. 2022;10(7):1876-1886.e7. https://doi.org/10.1016/j. jaip.2022.02.034
21. Abdulwahhab WS, Mehair AS. Dupilumab Injection in the Management of Steroid-Induced Rosacea: A New Case Report. Journal of Cosmetics, Dermatological Sciences and Applications. 2021;11(1):10-7.
22. Beck LA, Deleuran M, Bissonnette R, et al. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May 1;23(3):393-408. https://doi.org/10.1007/s40257-022-00685-0
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25. Zhou B, Peng C, Li L, et al. Efficacy and Safety of Dupilumab in Chinese Patients With Atopic Dermatitis: A Real-World Study. Frontiers in Medicine [Internet]. 2022 [cited 2023 May 28];9. Available from: https://www.frontiersin.org/articles/10.3389/ fmed.2022.838030
26. Stingeni L, Bianchi L, Antonelli E, et al. Moderate‐to‐severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real‐world experience. J Eur Acad Dermatol Venereol. 2022;36(8):1292-9. https://doi.org/10.1111/ jdv.18141
27. Uchida H, Kamata M, Mizukawa I, et al. Real‐world effectiveness and safety of dupilumab for the treatment of atopic dermatitis in Japanese patients: a single‐centre retrospective study. British Journal of Dermatology. 2019;181(5):1083-5. https://doi. org/10.1111/bjd.18163
28. Faiz S, Giovannelli J, Podevin C, et al. Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a reallife French multicenter adult cohort. Journal of the American Academy of Dermatology. 2019;81(1):143-51. https://doi. org/10.1016/j.jaad.2019.02.053
29. Nettis E, Ferrucci S, Ortoncelli M, et al. Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study. J Investig Allergol Clin. 2022;32(2):124-32. https://doi.org/10.18176/jiaci.0641
30. Jang DH, Heo SJ, Jung HJ, et al. Retrospective Study of Dupilumab Treatment for Moderate to Severe Atopic Dermatitis in Korea: Efficacy and Safety of Dupilumab in Real-World Practice. Journal of Clinical Medicine. 2020;9(6):1982. https://doi. org/10.3390/jcm9061982
31. Kreeshan FC, Al-Janabi A, Warren RB, et al. Real-World Experience and Laboratory Monitoring of Dupilumab in Patients with Moderate to Severe Atopic Dermatitis in a Tertiary Centre. Dermatol Ther (Heidelb). 2021;11(1):149-60. https://doi. org/10.1007/s13555-020-00469-6
32. Sánchez-Hernández MC, Montero J, Rondon C, et al. Consensus document on allergic conjunctivitis (DECA). J Investig Allergol Clin Immunol. 2015;25(2):94-106.
33. Londoño J, Perez L, Moreno S, et al. Effectiveness and safety of dupilumab in adults with moderate and severe atopic dermatitis in Colombia: Real-life experience. World Allergy Organization Journal. 2023;16(4):100763. https://doi.org/10.1016/j. waojou.2023.100763
34. Georgakopoulos JR, Felfeli T, Drucker AM, et al. Two-year efficacy, safety, and drug survival of dupilumab for atopic dermatitis: A real-world Canadian multicenter retrospective study. JAAD Int. 2021;4:67-9. https://doi.org/10.1016/j.jdin.2021.06.001
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37. de Wijs LEM, Bosma AL, Erler NS, et al. Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. Br J Dermatol. 2020;182(2):418-26. https://doi.org/10.1111/bjd.18179
38. Jo CE, Georgakopoulos JR, Ladda M, et al. Evaluation of long-term efficacy, safety, and reasons for discontinuation of dupilumab for moderate to severe atopic dermatitis in clinical practice: A retrospective cohort study. Journal of the American Academy of Dermatology. 2020;82(6):1530-2. https://doi.org/10.1016/j.jaad.2020.02.029
39. Lusignan S de, Alexander H, Broderick C, et al. Atopic dermatitis and risk of autoimmune conditions: Population-based cohort study. Journal of Allergy and Clinical Immunology. 2022;150(3):709-13. https://doi.org/10.1016/j.jaci.2022.03.030
40. Krishna MT, Subramanian A, Adderley NJ, et al. Allergic diseases and long-term risk of autoimmune disorders: longitudinal cohort study and cluster analysis. European Respiratory Journal [Internet]. 2019 Nov 1 [cited 2023 Jun 17];54(5). Available from: https://erj.ersjournals.com/content/54/5/1900476
41. Takeoka S, Kamata M, Yokoi I, et al. Rapid Enlargement of Vitiligo Vulgaris after Initiation of Dupilumab for Atopic Dermatitis: A Case Report. Acta Derm Venereol. 2021;101(10):adv00581. https://doi.org/10.2340/actadv.v101.545
42. Picone V, Napolitano M, Torta G, et al. Vitiligo during dupilumab therapy. JAAD Case Rep. 2023;36:51-3. https://doi. org/10.1016/j.jdcr.2023.03.025
43. Abdulwahhab WS, Alamiri FI, Mehair AS, et al. Punctal Stenosis a Rare Complication of Dupilumab Therapy for Atopic Dermatitis: A New Case Report. Journal of Cosmetics, Dermatological Sciences and Applications. 2021;11(2):96-100.
44. Lee DH, Cohen LM, Yoon MK, et al. Punctal stenosis associated with dupilumab therapy for atopic dermatitis. Journal of Dermatological Treatment [Internet]. 2020 Jan 7 [cited 2023 Apr 4]; Available from: https://www.tandfonline.com/doi/abs/1 0.1080/09546634.2019.1711010
45. Dhar S, De A, Srinivas SM. Real-World Effectiveness and Safety of Dupilumab for the Treatment of Moderate to Severe Atopic Dermatitis in Indian Patients: A Multi Centric Retrospective Study. Indian J Dermatol. 2021;66(3):297-301. https://doi. org/10.4103/ijd.ijd_860_20
46. Eichenfield LF, Armstrong A, Guttman-Yassky E, et al. Real-World Effectiveness of Dupilumab in Atopic Dermatitis Patients: Analysis of an Electronic Medical Records Dataset. Dermatol Ther (Heidelb). 2022;12(6):1337-50. https://doi.org/10.1007/ s13555-022-00731-z
47. Yang DY, Li L, Lu T, et al. Efficacy and safety of dupilumab in pediatric patients with moderate to severe atopic dermatitis: a real-world study. Arch Dermatol Res. 2023;315(3):467-72. https://doi.org/10.1007/s00403-022-02380-w
2. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis. Journal of the American Academy of Dermatology. 2014;70(2):338-51. Https://doi. org/10.1016/j.jaad.2013.10.010 3. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: Section
3. Management and treatment with phototherapy and systemic agents. Journal of the American Academy of Dermatology. 2014;71(2):327-49. https://doi.org/10.1016/j.jaad.2014.03.030
4. Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591). DUPIXENT® (dupilumab) injection, for subcutaneous use Initial U.S. Approval: 2017. [Internet]. 2017 [cited 2022 Nov 23]. Available from: Available at: https://www.accessdata.fda.gov/ drugsatfda_docs/label/2017/761055lbl.pdf
5. Harb H, Chatila T. Mechanisms of Dupilumab. Clin Exp Allergy. 2020;50(1):5-14. https://doi.org/10.1111/cea.13491
6. Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. Journal of the European Academy of Dermatology and Venereology. 2018;32(5):657- 82. https://doi.org/10.1111/jdv.14891
7. Press Release: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis - Sanofi [Internet]. [cited 2022 Nov 7]. Available from: https://www.sanofi.com/en/ media-room/press-releases/2022/2022-06-07-20-45-00-2458243
8. Al Hammadi A, Pakran J, Farghaly M, et al. Healthcare Resource Utilization and Direct Cost of Patients with Atopic Dermatitis in Dubai, United Arab Emirates: A Retrospective Cohort Study. Dermatol Ther (Heidelb). 2022;12(8):1859-83. https://doi. org/10.1007/s13555-022-00769-z
9. Sample Size Calculator by Raosoft, Inc. [Internet]. [cited 2023 Jun 11]. Available from: http://www.raosoft.com/samplesize. html
10. DUPIXENT® (dupilumab) Dosage [Internet]. [cited 2023 Jun 14]. Available from: https://www.dupixenthcp.com/ atopicdermatitis/dosage-administration
11. Oranje AP. Practical Issues on Interpretation of Scoring Atopic Dermatitis: SCORAD Index, Objective SCORAD, Patient-Oriented SCORAD and Three-Item Severity Score. Pathogenesis and Management of Atopic Dermatitis. 2011;41:149-55. https://doi. org/10.1159/000323308
12. Hanifin JM, Baghoomian W, Grinich E, et al. The Eczema Area and Severity Index—A Practical Guide. Dermatitis. 2022;33(3):187- 92. https://doi.org/10.1097/der.0000000000000895
13. Leshem YA, Hajar T, Hanifin JM, 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;172(5):1353-7. https://doi.org/10.1111/bjd.13662
14. Simpson E, Bissonnette R, Eichenfield LF, et al. The Validated Investigator Global Assessment for Atopic Dermatitis (vIGAAD): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis. Journal of the American Academy of Dermatology. 2020;83(3):839-46. https://doi.org/10.1016/j.jaad.2020.04.104
15. F A, J V, Ay F. Counting the Burden: Atopic Dermatitis and Health-related Quality of Life. Acta dermato-venereologica [Internet]. 2020 Jun 9 [cited 2022 Nov 14];100(12). Available from: https://pubmed.ncbi.nlm.nih.gov/32412644/
16. Basra MKA, Salek MS, Camilleri L, et al. Determining the Minimal Clinically Important Difference and Responsiveness of the Dermatology Life Quality Index (DLQI): Further Data. DRM. 2015;230(1):27-33. https://doi.org/10.1159/000365390
17. Yosipovitch G, Reaney M, Mastey V, et al. Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate‐to‐severe atopic dermatitis. Br J Dermatol. 2019;181(4):761-9. https://doi. org/10.1111/bjd.17744
18. Husein-ElAhmed H, Steinhoff M. Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. Journal of Dermatological Treatment. 2022 Apr 3;33(3):1547-53. https://doi.org/10.1080/095 46634.2020.1853024
19. Rathinam KK, Abraham JJ, Vijayakumar TM. Dupilumab in the Treatment of Moderate to Severe Asthma: An Evidence-Based Review. Curr Ther Res Clin Exp. 2019;91:45-51. https://pubmed.ncbi.nlm.nih.gov/31871508/
20. Cai S, Xu S, Lou H, et al. Comparison of Different Biologics for Treating Chronic Rhinosinusitis With Nasal Polyps: A Network Analysis. The Journal of Allergy and Clinical Immunology: In Practice. 2022;10(7):1876-1886.e7. https://doi.org/10.1016/j. jaip.2022.02.034
21. Abdulwahhab WS, Mehair AS. Dupilumab Injection in the Management of Steroid-Induced Rosacea: A New Case Report. Journal of Cosmetics, Dermatological Sciences and Applications. 2021;11(1):10-7.
22. Beck LA, Deleuran M, Bissonnette R, et al. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May 1;23(3):393-408. https://doi.org/10.1007/s40257-022-00685-0
23. Hansel TT, Kropshofer H, Singer T, et al. The safety and side effects of monoclonal antibodies. Nat Rev Drug Discov. 2010;9(4):325- 38. https://doi.org/10.1038/nrd3003
24. Ou Z, Chen C, Chen A, et al. Adverse events of Dupilumab in adults with moderate-to-severe atopic dermatitis: A metaanalysis. International Immunopharmacology. 2018;54:303-10. https://doi.org/10.1016/j.intimp.2017.11.031
25. Zhou B, Peng C, Li L, et al. Efficacy and Safety of Dupilumab in Chinese Patients With Atopic Dermatitis: A Real-World Study. Frontiers in Medicine [Internet]. 2022 [cited 2023 May 28];9. Available from: https://www.frontiersin.org/articles/10.3389/ fmed.2022.838030
26. Stingeni L, Bianchi L, Antonelli E, et al. Moderate‐to‐severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real‐world experience. J Eur Acad Dermatol Venereol. 2022;36(8):1292-9. https://doi.org/10.1111/ jdv.18141
27. Uchida H, Kamata M, Mizukawa I, et al. Real‐world effectiveness and safety of dupilumab for the treatment of atopic dermatitis in Japanese patients: a single‐centre retrospective study. British Journal of Dermatology. 2019;181(5):1083-5. https://doi. org/10.1111/bjd.18163
28. Faiz S, Giovannelli J, Podevin C, et al. Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a reallife French multicenter adult cohort. Journal of the American Academy of Dermatology. 2019;81(1):143-51. https://doi. org/10.1016/j.jaad.2019.02.053
29. Nettis E, Ferrucci S, Ortoncelli M, et al. Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study. J Investig Allergol Clin. 2022;32(2):124-32. https://doi.org/10.18176/jiaci.0641
30. Jang DH, Heo SJ, Jung HJ, et al. Retrospective Study of Dupilumab Treatment for Moderate to Severe Atopic Dermatitis in Korea: Efficacy and Safety of Dupilumab in Real-World Practice. Journal of Clinical Medicine. 2020;9(6):1982. https://doi. org/10.3390/jcm9061982
31. Kreeshan FC, Al-Janabi A, Warren RB, et al. Real-World Experience and Laboratory Monitoring of Dupilumab in Patients with Moderate to Severe Atopic Dermatitis in a Tertiary Centre. Dermatol Ther (Heidelb). 2021;11(1):149-60. https://doi. org/10.1007/s13555-020-00469-6
32. Sánchez-Hernández MC, Montero J, Rondon C, et al. Consensus document on allergic conjunctivitis (DECA). J Investig Allergol Clin Immunol. 2015;25(2):94-106.
33. Londoño J, Perez L, Moreno S, et al. Effectiveness and safety of dupilumab in adults with moderate and severe atopic dermatitis in Colombia: Real-life experience. World Allergy Organization Journal. 2023;16(4):100763. https://doi.org/10.1016/j. waojou.2023.100763
34. Georgakopoulos JR, Felfeli T, Drucker AM, et al. Two-year efficacy, safety, and drug survival of dupilumab for atopic dermatitis: A real-world Canadian multicenter retrospective study. JAAD Int. 2021;4:67-9. https://doi.org/10.1016/j.jdin.2021.06.001
35. dupixent_ppi.pdf [Internet]. [cited 2023 Jun 10]. Available from: https://www.regeneron.com/downloads/dupixent_ppi.pdf
36. Wang C, Kraus CN, Patel KG, et al. Real-world experience of dupilumab treatment for atopic dermatitis in adults: a retrospective analysis of patients’ records. International Journal of Dermatology. 2020;59(2):253-6. https://doi.org/10.1111/ijd.14573
37. de Wijs LEM, Bosma AL, Erler NS, et al. Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. Br J Dermatol. 2020;182(2):418-26. https://doi.org/10.1111/bjd.18179
38. Jo CE, Georgakopoulos JR, Ladda M, et al. Evaluation of long-term efficacy, safety, and reasons for discontinuation of dupilumab for moderate to severe atopic dermatitis in clinical practice: A retrospective cohort study. Journal of the American Academy of Dermatology. 2020;82(6):1530-2. https://doi.org/10.1016/j.jaad.2020.02.029
39. Lusignan S de, Alexander H, Broderick C, et al. Atopic dermatitis and risk of autoimmune conditions: Population-based cohort study. Journal of Allergy and Clinical Immunology. 2022;150(3):709-13. https://doi.org/10.1016/j.jaci.2022.03.030
40. Krishna MT, Subramanian A, Adderley NJ, et al. Allergic diseases and long-term risk of autoimmune disorders: longitudinal cohort study and cluster analysis. European Respiratory Journal [Internet]. 2019 Nov 1 [cited 2023 Jun 17];54(5). Available from: https://erj.ersjournals.com/content/54/5/1900476
41. Takeoka S, Kamata M, Yokoi I, et al. Rapid Enlargement of Vitiligo Vulgaris after Initiation of Dupilumab for Atopic Dermatitis: A Case Report. Acta Derm Venereol. 2021;101(10):adv00581. https://doi.org/10.2340/actadv.v101.545
42. Picone V, Napolitano M, Torta G, et al. Vitiligo during dupilumab therapy. JAAD Case Rep. 2023;36:51-3. https://doi. org/10.1016/j.jdcr.2023.03.025
43. Abdulwahhab WS, Alamiri FI, Mehair AS, et al. Punctal Stenosis a Rare Complication of Dupilumab Therapy for Atopic Dermatitis: A New Case Report. Journal of Cosmetics, Dermatological Sciences and Applications. 2021;11(2):96-100.
44. Lee DH, Cohen LM, Yoon MK, et al. Punctal stenosis associated with dupilumab therapy for atopic dermatitis. Journal of Dermatological Treatment [Internet]. 2020 Jan 7 [cited 2023 Apr 4]; Available from: https://www.tandfonline.com/doi/abs/1 0.1080/09546634.2019.1711010
45. Dhar S, De A, Srinivas SM. Real-World Effectiveness and Safety of Dupilumab for the Treatment of Moderate to Severe Atopic Dermatitis in Indian Patients: A Multi Centric Retrospective Study. Indian J Dermatol. 2021;66(3):297-301. https://doi. org/10.4103/ijd.ijd_860_20
46. Eichenfield LF, Armstrong A, Guttman-Yassky E, et al. Real-World Effectiveness of Dupilumab in Atopic Dermatitis Patients: Analysis of an Electronic Medical Records Dataset. Dermatol Ther (Heidelb). 2022;12(6):1337-50. https://doi.org/10.1007/ s13555-022-00731-z
47. Yang DY, Li L, Lu T, et al. Efficacy and safety of dupilumab in pediatric patients with moderate to severe atopic dermatitis: a real-world study. Arch Dermatol Res. 2023;315(3):467-72. https://doi.org/10.1007/s00403-022-02380-w
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Assessment of long-term safety and efficacy of Dupilumab therapy in patients with moderate-to-severe atopic dermatitis in the UAE: A real-life observational study. Pharm Pract (Granada) [Internet]. 2024 May 31 [cited 2025 Apr. 25];22(2):1-11. Available from: https://www.pharmacypractice.org/index.php/pp/article/view/2947
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Assessment of long-term safety and efficacy of Dupilumab therapy in patients with moderate-to-severe atopic dermatitis in the UAE: A real-life observational study. Pharm Pract (Granada) [Internet]. 2024 May 31 [cited 2025 Apr. 25];22(2):1-11. Available from: https://www.pharmacypractice.org/index.php/pp/article/view/2947