|Year : 2020 | Volume
| Issue : 5 | Page : 835-837
A real-world analysis of relapse rate and efficacy of a restricted monthly dose of omalizumab in recalcitrant chronic spontaneous urticaria in India
Kabir Sardana, Niharika Dixit, Pooja Arora
Department of Dermatology, Venereology and Leprosy, Dr. Ram Manohar Lohia Hospital and Post Graduate Institute of Medical Education and Research, Baba Kharak Singh Marg, New Delhi, India
|Date of Submission||02-Oct-2019|
|Date of Decision||15-May-2020|
|Date of Acceptance||03-Jul-2020|
|Date of Web Publication||19-Sep-2020|
B-304 Nanda Devi Apt, Plot No. 19, Sector-10, Dwarka, New Delhi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Sardana K, Dixit N, Arora P. A real-world analysis of relapse rate and efficacy of a restricted monthly dose of omalizumab in recalcitrant chronic spontaneous urticaria in India. Indian Dermatol Online J 2020;11:835-7
|How to cite this URL:|
Sardana K, Dixit N, Arora P. A real-world analysis of relapse rate and efficacy of a restricted monthly dose of omalizumab in recalcitrant chronic spontaneous urticaria in India. Indian Dermatol Online J [serial online] 2020 [cited 2020 Oct 23];11:835-7. Available from: https://www.idoj.in/text.asp?2020/11/5/835/295579
Omalizumab is a third-line drug for chronic urticaria but financial constraints limit its long-term use. An expert group of dermatologists under the aegis of Ministry of Health and Family Welfare– Government of India had stipulated that three doses of omalizumab should be administered in relevant cases of chronic spontaneous urticaria (CSU). The dosimetry recommended was injection omalizumab 300 mg every month for 3 months, in case a patient did not achieve a 50% decrease in UAS score at 4 weeks after the first dose, the next dose was not administered. In exceptional cases where there was 50% reduction in UAS score more than 3 doses were administered. As there is paucity of data on the real-world experience with this drug, especially in central government institutes in India, we undertook a retrospective evaluation of patients with CSU treated with omalizumab in 2016–2018 with this regimen. Eighteen patients of refractory CSU were divided in 3 groups based on the number of doses of omalizumab given. Ten patients (56%) received 3 doses, 5 (28%) received less than 3 doses, and 3 (17%) received more than 3 doses. The follow-up records were evaluated and response to treatment and relapses were noted. Demographic data were recorded, including age, sex, duration of disease, prior and concurrent treatment [Table 1]. The severity of disease was recorded as weekly “urticaria activity score” (UAS7). Response to treatment was assessed by using visual analog scale (VAS) and was graded as follows: Complete response (CR): more than 90% reduction of symptoms (VAS = 4-5), Partial response (PR): 30–80% reduction of symptoms (VAS = 2–3), and no response (NR): less than 30% reduction of symptoms (VAS = 0–1). Data was presented as number (%) or Mean ± SD. Changes in continuous outcome measures were evaluated using means, SDs, P values, and 95% confidence intervals (CIs). P values for continuous outcome measures were generated via t tests (one-way analysis of variance; ANOVA) and to compare proportions between groups z test was used. Statistical significance was declared when P was less than 0.05.
|Table 1: Demographic profile, previous treatment, mean UAS7 (Pre and Post-omalizumab)|
Click here to view
The results revealed complete response (CR) in all 10 cases (100%) who were given 3 doses of omalizumab. Of the 5 cases with less than 3 doses of omalizumab, 1/5 (20%) had CR, 2/5 (40%) had PR and 2/5 (40%) had NR and among those with more than 3 doses, 2/3 (67%) had CR and 1/3 (33%) had PR [Table 2]. The mean VAS of patients who were given 3 doses, less than 3 and more than 3 doses of omalizumab were 4.8 ± 0.4, 3 ± 1.3 and 4 ± 1.4, respectively, and the difference was statistically significant (P = 0.008) [Table 2]. Relapse after stopping omalizumab was observed in 9 (56%) patients out of 16 patients who responded [Table 2]. The relapse rate was 40% for patients who received 3 doses and 33.3% for patients more than 3 doses and the difference was not found to be statistically significant (P = 0.8336). Out of these, 1 (11%) patient relapsed within 6 months, 2 (22%) within 2 months, 4 (44%) within 1 month, and 2 (22%) within 15 days of stopping therapy.
|Table 2: A comparison of response parameters and severity of relapsed disease in patients with different doses of omalizumab|
Click here to view
Although many studies including the large multicenter, randomized, double-blind, placebo-controlled phase III trials (ASTERIA I, ASTERIA II, and GLACIAL) have shown that omalizumab significantly improved CSU compared with placebo, recurrence of disease after stopping treatment has been a problem and very few studies have commented upon the real-world experience on relapses with this drug in CSU specially in India.,, Relapse after omalizumab has been found to be dependent on two important factors: high baseline UAS7 and slow initiation of response., In our study, 9 of the 16 cases experienced relapse. In previous studies the relapse rates range from as low as 5% to as high as 87.5%, but the mean relapse rate was 54.6 ± 29.5%., The variable relapse rate reflects the variable doses and intervals of the drug in different studies., Our relapse rate of 56% was subanalyzed and it was found that it was dependent on the number of doses, with a relapse rate of 40% at 3 doses which reduced to 33.33% with more than 3 doses. In the XTEND-CIU trial (Xolair Treatment Efficacy of LoNger Duration in Chronic Idiopathic Urticaria), a relapse rate of 43.4% and 45.1% was observed during the 12 weeks after withdrawing omalizumab in patients treated for as long as 24 or 48 weeks. Preliminary results from the OPTIMA study also showed a 44.4–50% relapse rate after 6 months of treatment. Furthermore, a real-life study of 280 patients reported that it was rarely possible to stop omalizumab even after 1–2 years of treatment. The significant analogy is that our relapse rate (56%) with limited doses of the drug is similar to these longer duration trials which suggests that while extending therapy to 6 or 12 months might be more effective but the relapse rates do not differ. The implications are that while taking a decision on administering the drug prolonging the duration is not necessarily curative and does not obviate the relapse rates. The limitations of the study include small number of patients and unavailability of the tests predicting the responsiveness to omalizumab. Further studies with large sample size are required to expound our work.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Central Government Health Scheme, Medical Store Depot. Guidelines for the use of Xolair in Chronic idiopathic Urticaria, 01-396/2016-17/CGHS/MSD/3129. New Delhi: Additional Director, Central Government Health Scheme, Medical Store Depot, Government of India; 2016.
Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bülbül Baskan E, Bradley MS, et al
. Efficacy and safety of omalizumab in patients with chronic idiopathic urticaria/chronic spontaneous urticaria who remain symptomatic on H1-antihistamines: A randomized placebo-controlled study. J Invest Dermatol 2015;135:67-75.
Ferrer M, Gimenez-Arau A, Saldana D, Janssens N, Balp MM, Khalil S, et al
. Predicting chronic spontaneous urticaria symptom return after omalizumab treatment discontinuation: Exploratory analysis. J Allergy Clin Immunol Pract 2018;6:1191-7.
Subramaniyan R, Chopra A. Treatment of chronic spontaneous urticaria with a single dose of omalizumab: A study of four cases. Indian J Dermatol 2016;61:467.
] [Full text]
Mandel VD, Guanti MB, Liberati S, Demonte A, Pellacani G, Pepe P. Omalizumab in chronic spontaneous urticaria refractory to conventional therapy: An Italian retrospective clinical analysis with suggestions for long-term maintenance strategies. Dermatol Ther 2018;8:291-301.
Syrigos N, Grapsa D, Zande M, Tziotou M, Syrigou E. Treatment response to omalizumab in patients with refractory chronic spontaneous urticaria. Int J Dermatol 2018;57:417-22.
Maurer M, Kaplan A, Rosén K, Holden M, Iqbal A, Trzaskoma BL, et al
. The XTEND-CIU study: Long-term use of omalizumab in chronic idiopathic urticaria. J Allergy Clin Immunol 2018;141:1138-9.
Sussman G, Hebert J, Gulliver W, Lynde C, Yang WH, Chambenoit O, et al
. Omalizumab retreatment of patients with chronic idiopathic urticaria/spontaneous urticaria (CIU/CSU) following return of symptoms: Primary results of the OPTIMA study. Poster presented at: The Fall Clinical Dermatology Conference; 2017 Oct 12-15; Las Vegas, NV, USA.
Vadasz Z, Tal Y, Rotem M, Shichter-Con fi no V, Mahlab-Guri K, Graif Y, et al
. Omalizumab for severe chronic spontaneous urticaria: Real-life experiences of 280 patients. J Allergy Clin Immunol Pract 2017;5:1743-5.
[Table 1], [Table 2]