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Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif bir çalışma

Year 2020, , 424 - 429, 30.12.2020
https://doi.org/10.18663/tjcl.772155

Abstract

Amaç: Bu çalışmada tedaviye dirençli kronik spontan ürtiker (KSÜ) nedeni ile omalizumab tedavisi kullanan hastaların klinik ve demografik özelliklerinin yanısıra omalizumab etkinliği ile yan etkilerinin geriye dönük olarak değerlendirilmesi amaçlanmıştır.
Gereç ve Yöntemler: Kliniğimizde 2014-2017 yılları arasında H1-antihistaminiklere direnç nedeni ile 300 mg/ay subkutan omalizumab başlanan KSÜ hastalarının kayıtlı bilgisayar verileri taranarak retrospektif olarak incelendi. Hiç ürtikeryal plağı ve kaşıntısı olmayanlar tam yanıtlı, tedavi başlangıcına göre hayat kalitesi artan ve semptomlarında belirgin iyileşme olanlar kısmi yanıtlı, semptomlarında hiç iyileşme olmayanlar yanıtsız olarak kabul edildi.
Bulgular: Tedaviye dirençli KSÜ nedeniyle omalizumab verilen 71 (41 K, 30 E) hasta çalışmaya dahil edildi. Bu hastaların ortalama hastalık süresi 54.6±52.9 (min-maks:8-360) ay olup, yaş ortalaması 43.6±16.4 (min-maks: 14-83) yıl idi. Omalizumab tedavisi 3. ayı sonunda hastaların yapılan değerlendirilmesinde, 14 (19.7%) hastada tam yanıt, 36 (50.7%) hastada kısmı yanıt görülürken, 21 (%29,6) hastada yanıt alınamadı. Başlangıç total IgE ve CRP düzeyleri, hastalık süresi, hasta yaşı, cinsiyeti, astım öyküsü ve immünsupresif kullanım öyküsü açısından 3. ay sonu omalizumab tedavisi yanıt grupları arasında herhangi bir istatistiksel farklılık tespit edilmedi (p>0.05). Hastalarda ciddi bir yan etki saptanmadı.
Sonuç: Bu çalışmada, KSÜ nedeniyle takip edilip omalizumab kullanılan hastalarda, omalizumab tedavisinin etkin ve güvenilir olduğunu tespit ettik.

References

  • 1. Antia C, Baquerizo K, Korman A, Bernstein JA, Alikhan A. Urticaria: A comprehensive review: Epidemiology, diagnosis, and work-up. J Am Acad Dermatol 2018; 79: 599-614.
  • 2. Poonawalla T, Kelly B. Urticaria : a review. Am J Clin Dermatol 2009; 10: 9-21.
  • 3. Zuberbier, T, Aberer W, Asero R et al. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy 2014; 69: 868-87.
  • 4. Chang T.W, Chen C, Lin C.J, Metz M, Church M.K, Maurer M. The potential pharmacologic mechanisms of omalizumab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol 2015; 135: 337-42.
  • 5. D’Amato G. Role of anti-IgE monoclonal antibody (omalizumab) in the treatment of bronchial asthma and allergic respiratory diseases. Eur J Pharmacol 2006; 533: 302-7.
  • 6. Lai T, Wang S, Xu Z et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep 2015; 5: 8191.
  • 7. Corren J, Casale T, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy 2009; 39: 788-97.
  • 8. Tat TS. Kronik spontan ürtikerde omalizumab tedavisinin etkinliği ve güvenliği. Cukurova Med J 2018; 43: 903-7.
  • 9. Nazik H, Mülayim MK, Öztürk P. Omalizumab usage in chronic urticaria and atopic dermatitis: data from South-East province of Turkey. Postepy Dermatol Alergol 2019; 36: 734-8.
  • 10. Balp MM, Khalil S, Tian H, Gabriel S, Vietri J, Zuberbier T. Burden of chronic urticaria relative to psoriasis in five European countries. J Eur Acad Dermatol Venereol 2018; 32: 282-90.
  • 11. Zuberbier T, Aberer W, Asero R et al. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy 2014; 69: 868-87.
  • 12. Saini S, Rosen KE, Hsieh HJ et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol 2011; 128: 567-73.
  • 13. Maurer M, Rosén K, Hsieh HJ et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med 2013; 368: 924-35.
  • 14. Metz M, Ohanyan T, Church MK, Maurer M. Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. J Dermatol Sci 2014; 73: 57-62.
  • 15. Tharp MD, Bernstein JA, Kavati A et al. Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of “Real-world” Evidence. JAMA Dermatol 2019; 155: 29–38.
  • 16. Türk M, Yılmaz İ, Bahçecioğlu SN. Treatment and retreatment with omalizumab in chronic spontaneous urticaria: Real life experience with twenty-five patients. Allergol Int 2018; 67: 85-9.
  • 17. Engin B, Çelik U, Birben AÖ et al. Omalizumab in chronic spontaneous urticaria treatment: Real life experiences Turkderm-Turk Arch Dermatol Venereology 2019; 53: 145-9
  • 18. Akyol A, Öktem A, Akay BN, Kundakçı N, Boyvat A. Omalizumab and treatment-resistant chronic spontaneous urticaria. Turkderm 2015; 49: 180-3.
  • 19. Türkmen M, Çoban M, Doğan S et al. Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif değerlendirilme. Turkderm-Turk Arch Dermatol Venereology 2019; 53: 65-7.
  • 20. Bernstein JA, Kavati A, Tharp MD et al. Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’evidence. Expert Opin Biol Ther 2018; 18: 425-48.
  • 21. Ertas R, Ozyurt K, Atasoy M, Hawro T, Maurer M. The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change. Allergy 2018; 73: 705-12.

The efficacy of omalizumab therapy in chronic spontaneous urticaria: A retrospective analysis

Year 2020, , 424 - 429, 30.12.2020
https://doi.org/10.18663/tjcl.772155

Abstract

Aim: In this study, it was aimed to evaluate the clinical and demographic features of patients using omalizumab therapy for treatment-resistant CSU, as well as the efficacy and side effects of omalizumab retrospectively.
Material and Methods: In our clinic, we retrospectively checked the computer data of CSU patients who began subcutaneous omalizumab 300 mg / month due to H1-antihistamin resistance between 2014 and 2017. Those without urticaria plaque and itching were considered to be a complete response; those with improved quality of life relative to the onset of treatment and significant improvement in their symptoms were considered to be a partial response; and those with no improvement in symptoms were considered to be unresponsive.
Results: Seventy-one (41 F, 30 M) patients who received omalizumab for treatment-resistant CSU were included in the study. The mean disease duration of these patients was 54.6 ± 52.9 (min-max: 8-360) months and the mean age was 43.6 ± 16.4 (min-max: 14-83) years. In patient evaluation at the end of the third month of treatment with omalizumab, 14 (19.7%) patients had complete response, 36 (50.7%) patients had partial response, whereas 21 (29.6 %) patients had no response. At the end of the 3rd month there was no statistical difference between the omalizumab treatment response groups in terms of baseline total IgE and CRP levels, disease duration, patient age, sex, history of asthma, and history of immunosuppressive use. There were no significant side effects in the patients.
Conclusion: In this study, we found that treatment with omalizumab was effective and safe in patients who were being followed up due to CSU and used omalizumab.

References

  • 1. Antia C, Baquerizo K, Korman A, Bernstein JA, Alikhan A. Urticaria: A comprehensive review: Epidemiology, diagnosis, and work-up. J Am Acad Dermatol 2018; 79: 599-614.
  • 2. Poonawalla T, Kelly B. Urticaria : a review. Am J Clin Dermatol 2009; 10: 9-21.
  • 3. Zuberbier, T, Aberer W, Asero R et al. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy 2014; 69: 868-87.
  • 4. Chang T.W, Chen C, Lin C.J, Metz M, Church M.K, Maurer M. The potential pharmacologic mechanisms of omalizumab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol 2015; 135: 337-42.
  • 5. D’Amato G. Role of anti-IgE monoclonal antibody (omalizumab) in the treatment of bronchial asthma and allergic respiratory diseases. Eur J Pharmacol 2006; 533: 302-7.
  • 6. Lai T, Wang S, Xu Z et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep 2015; 5: 8191.
  • 7. Corren J, Casale T, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy 2009; 39: 788-97.
  • 8. Tat TS. Kronik spontan ürtikerde omalizumab tedavisinin etkinliği ve güvenliği. Cukurova Med J 2018; 43: 903-7.
  • 9. Nazik H, Mülayim MK, Öztürk P. Omalizumab usage in chronic urticaria and atopic dermatitis: data from South-East province of Turkey. Postepy Dermatol Alergol 2019; 36: 734-8.
  • 10. Balp MM, Khalil S, Tian H, Gabriel S, Vietri J, Zuberbier T. Burden of chronic urticaria relative to psoriasis in five European countries. J Eur Acad Dermatol Venereol 2018; 32: 282-90.
  • 11. Zuberbier T, Aberer W, Asero R et al. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy 2014; 69: 868-87.
  • 12. Saini S, Rosen KE, Hsieh HJ et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin Immunol 2011; 128: 567-73.
  • 13. Maurer M, Rosén K, Hsieh HJ et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med 2013; 368: 924-35.
  • 14. Metz M, Ohanyan T, Church MK, Maurer M. Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. J Dermatol Sci 2014; 73: 57-62.
  • 15. Tharp MD, Bernstein JA, Kavati A et al. Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of “Real-world” Evidence. JAMA Dermatol 2019; 155: 29–38.
  • 16. Türk M, Yılmaz İ, Bahçecioğlu SN. Treatment and retreatment with omalizumab in chronic spontaneous urticaria: Real life experience with twenty-five patients. Allergol Int 2018; 67: 85-9.
  • 17. Engin B, Çelik U, Birben AÖ et al. Omalizumab in chronic spontaneous urticaria treatment: Real life experiences Turkderm-Turk Arch Dermatol Venereology 2019; 53: 145-9
  • 18. Akyol A, Öktem A, Akay BN, Kundakçı N, Boyvat A. Omalizumab and treatment-resistant chronic spontaneous urticaria. Turkderm 2015; 49: 180-3.
  • 19. Türkmen M, Çoban M, Doğan S et al. Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif değerlendirilme. Turkderm-Turk Arch Dermatol Venereology 2019; 53: 65-7.
  • 20. Bernstein JA, Kavati A, Tharp MD et al. Effectiveness of omalizumab in adolescent and adult patients with chronic idiopathic/spontaneous urticaria: a systematic review of ‘real-world’evidence. Expert Opin Biol Ther 2018; 18: 425-48.
  • 21. Ertas R, Ozyurt K, Atasoy M, Hawro T, Maurer M. The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change. Allergy 2018; 73: 705-12.
There are 21 citations in total.

Details

Primary Language Turkish
Subjects Health Care Administration
Journal Section Orıgınal Artıcle
Authors

Fatmaelif Yıldırım

Publication Date December 30, 2020
Published in Issue Year 2020

Cite

APA Yıldırım, F. (2020). Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif bir çalışma. Turkish Journal of Clinics and Laboratory, 11(5), 424-429. https://doi.org/10.18663/tjcl.772155
AMA Yıldırım F. Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif bir çalışma. TJCL. December 2020;11(5):424-429. doi:10.18663/tjcl.772155
Chicago Yıldırım, Fatmaelif. “Kronik Spontan ürtikerde Omalizumab Tedavisinin etkinliği: Retrospektif Bir çalışma”. Turkish Journal of Clinics and Laboratory 11, no. 5 (December 2020): 424-29. https://doi.org/10.18663/tjcl.772155.
EndNote Yıldırım F (December 1, 2020) Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif bir çalışma. Turkish Journal of Clinics and Laboratory 11 5 424–429.
IEEE F. Yıldırım, “Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif bir çalışma”, TJCL, vol. 11, no. 5, pp. 424–429, 2020, doi: 10.18663/tjcl.772155.
ISNAD Yıldırım, Fatmaelif. “Kronik Spontan ürtikerde Omalizumab Tedavisinin etkinliği: Retrospektif Bir çalışma”. Turkish Journal of Clinics and Laboratory 11/5 (December 2020), 424-429. https://doi.org/10.18663/tjcl.772155.
JAMA Yıldırım F. Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif bir çalışma. TJCL. 2020;11:424–429.
MLA Yıldırım, Fatmaelif. “Kronik Spontan ürtikerde Omalizumab Tedavisinin etkinliği: Retrospektif Bir çalışma”. Turkish Journal of Clinics and Laboratory, vol. 11, no. 5, 2020, pp. 424-9, doi:10.18663/tjcl.772155.
Vancouver Yıldırım F. Kronik spontan ürtikerde omalizumab tedavisinin etkinliği: Retrospektif bir çalışma. TJCL. 2020;11(5):424-9.


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