Ann Allergy Asthma Immunol 115 (2015) 536
Contents lists available at ScienceDirect
Correspondence
Long-term omalizumab therapy for refractory chronic spontaneous urticaria: a real-life experience Omalizumab is an anti-IgE drug that has proved to be effective in the treatment of recalcitrant chronic urticaria (CU). It has recently been approved in many countries for CU treatment, but there are few data on its long-term effectiveness and safety. Har et al1 reported the outcomes of using omalizumab for more than 1 year in 10 patients with refractory CU in the United States. We retrospectively analyzed data from CU patients treated with omalizumab for more than 1 year from June 2012 to June 2015. Treatment started with 150-mg or 300-mg doses (according to its availability for each patient) every 4 weeks. After 6 months of treatment, doses were increased to 300 mg for those with no response or partial response (improvement on urticaria but still with symptoms or additionally taking antihistamine) or decreased to 150 mg for the complete responders (total absence of symptoms). When a complete response was maintained with a 150-mg dose for more than 6 months, an additional progressive 2-week interval was added between injections. Nine patients (7 women; mean age, 39 years) were treated with omalizumab for a long term (mean, 23 months; range, 12e61 months) for CU. All these patients were resistant to high-dose second-generation H1-antihistamines and depended on oral corticosteroids to control their symptoms. Autoimmunity, as defined by the presence of a positive autologous skin test result and/or the presence of antithyroid or antinuclear antibodies, was investigated in 7 of the 9 patients, and 43% of them had evidence of autoimmunity. Two patients started the treatment with a 150-mg dose. One had a complete response (CR) and is currently taking omalizumab every 6 weeks, and the other had a partial response (slightly improved with a higher dose of 300 mg). Five of 7 patients who started with a 300-mg dose had a CR. Two maintained a CR when stepped down to 150 mg and are currently being treated at 4- and 12-week intervals. The other 2 had a relapse with the lower dose and are still taking 300 mg every 4 weeks. One patient was
concerned about changing her treatment regimen and preferred to continue to take 300 mg every 4 weeks even though she was a complete responder. Urticaria treatment aims for total symptoms control.2 However, in a country where access to treatment is limited by economic issues in the general population, therapy should be individualized. In this way, we used a different doses regimen and a step up/step down approach, which was effective in long-term control of symptoms. In conclusion, as reported by other researchers, some of our patients underwent remission with lower doses and longer intervals, and none had to take corticosteroids to have their symptoms controlled.1,3 In addition, no significant adverse reactions were reported during the treatment, confirming its longterm safety profile. Luis Felipe Ensina, MD, MSc*,y Alex Eustáquio de Lacerda, MD* Ligia Maria de Oliveira Machado, MD* Inês Camelo-Nunes, MD, PhD*,y Dirceu Solé, MD, PhD* *Federal University of São Paulo y University of Santo Amaro São Paulo, Brazil [email protected]
References [1] Har D, Patel S, Khan DA. Outcomes of using omalizumab for more than 1 year in refractory chronic urticaria. Ann Allergy Asthma Immunol. 2015;115:126e129. [2] 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;69:868e887. [3] Silva PM, Costa AC, Mendes A, Barbosa MP. Long-term efficacy of omalizumab in seven patients with treatment-resistant chronic spontaneous urticaria. Allergol Immunopathol (Madr). 2015;43:168e173.
Disclosures: Authors have nothing to disclose. http://dx.doi.org/10.1016/j.anai.2015.09.012 1081-1206/Ó 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Contents lists available at ScienceDirect
Correspondence
Long-term omalizumab therapy for refractory chronic spontaneous urticaria: a real-life experience Omalizumab is an anti-IgE drug that has proved to be effective in the treatment of recalcitrant chronic urticaria (CU). It has recently been approved in many countries for CU treatment, but there are few data on its long-term effectiveness and safety. Har et al1 reported the outcomes of using omalizumab for more than 1 year in 10 patients with refractory CU in the United States. We retrospectively analyzed data from CU patients treated with omalizumab for more than 1 year from June 2012 to June 2015. Treatment started with 150-mg or 300-mg doses (according to its availability for each patient) every 4 weeks. After 6 months of treatment, doses were increased to 300 mg for those with no response or partial response (improvement on urticaria but still with symptoms or additionally taking antihistamine) or decreased to 150 mg for the complete responders (total absence of symptoms). When a complete response was maintained with a 150-mg dose for more than 6 months, an additional progressive 2-week interval was added between injections. Nine patients (7 women; mean age, 39 years) were treated with omalizumab for a long term (mean, 23 months; range, 12e61 months) for CU. All these patients were resistant to high-dose second-generation H1-antihistamines and depended on oral corticosteroids to control their symptoms. Autoimmunity, as defined by the presence of a positive autologous skin test result and/or the presence of antithyroid or antinuclear antibodies, was investigated in 7 of the 9 patients, and 43% of them had evidence of autoimmunity. Two patients started the treatment with a 150-mg dose. One had a complete response (CR) and is currently taking omalizumab every 6 weeks, and the other had a partial response (slightly improved with a higher dose of 300 mg). Five of 7 patients who started with a 300-mg dose had a CR. Two maintained a CR when stepped down to 150 mg and are currently being treated at 4- and 12-week intervals. The other 2 had a relapse with the lower dose and are still taking 300 mg every 4 weeks. One patient was
concerned about changing her treatment regimen and preferred to continue to take 300 mg every 4 weeks even though she was a complete responder. Urticaria treatment aims for total symptoms control.2 However, in a country where access to treatment is limited by economic issues in the general population, therapy should be individualized. In this way, we used a different doses regimen and a step up/step down approach, which was effective in long-term control of symptoms. In conclusion, as reported by other researchers, some of our patients underwent remission with lower doses and longer intervals, and none had to take corticosteroids to have their symptoms controlled.1,3 In addition, no significant adverse reactions were reported during the treatment, confirming its longterm safety profile. Luis Felipe Ensina, MD, MSc*,y Alex Eustáquio de Lacerda, MD* Ligia Maria de Oliveira Machado, MD* Inês Camelo-Nunes, MD, PhD*,y Dirceu Solé, MD, PhD* *Federal University of São Paulo y University of Santo Amaro São Paulo, Brazil [email protected]
References [1] Har D, Patel S, Khan DA. Outcomes of using omalizumab for more than 1 year in refractory chronic urticaria. Ann Allergy Asthma Immunol. 2015;115:126e129. [2] 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;69:868e887. [3] Silva PM, Costa AC, Mendes A, Barbosa MP. Long-term efficacy of omalizumab in seven patients with treatment-resistant chronic spontaneous urticaria. Allergol Immunopathol (Madr). 2015;43:168e173.
Disclosures: Authors have nothing to disclose. http://dx.doi.org/10.1016/j.anai.2015.09.012 1081-1206/Ó 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
