Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study

Litovsky, Julie; Hacard, Florence; Tétart, Florence; Boccon-Gibod, Isabelle; Soria, Angèle; Staumont-Sallé, Delphine; Doutre, Marie-Sylvie; Amsler, Emmanuelle; Mansard, Catherine; Dezoteux, Frédéric; Darrigade, Anne-Sophie; Milpied, Brigitte; Bernier, Claire; Perrot, Jean-Luc; Raison-Peyron, Nadia; Paryl, Marie; Droitcourt, Catherine; Demoly, Pascal; Grosjean, Julien; Mura, Thibault; Du-Thanh, Aurélie

doi:10.1016/j.jaip.2023.08.033

Cited by 5 publications

(5 citation statements)

References 43 publications

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“…Interestingly, patients with predominantly chronic spontaneous urticaria had a shorter overall omalizumab survival compared to patients with predominantly chronic inducible urticaria, reflecting a longer estimated treatment duration in patients with chronic inducible urticaria, contradictory to a previous omalizumab drug survival study . We also observed that the presence of chronic inducible urticaria was associated with a longer time to discontinuation due to well-controlled disease and was not associated with a shorter time to discontinuation due to ineffectiveness.…”

Section: Discussioncontrasting

confidence: 71%

“…Drug survival analyses measure the performance of drugs in daily practice, incorporating effectiveness and safety as well as patient and physician preference, while estimating the length of time until an event occurs, such as the discontinuation of omalizumab treatment, reflecting the treatment duration of the drug. To date, 4 smaller omalizumab survival studies in patients with chronic urticaria have been performed . They showed a decrease in survival rates from 71% to 65% within 1 to 1.5 years and from 77% to 55% within 1 to 3 years, with well-controlled disease as a major reason for discontinuation .…”

Section: Introductionmentioning

confidence: 99%

“…These previous studies were limited by small populations (range of sample sizes, 38-298 participants) and short follow-up (range, 32-72 months) . Characterization of determinants of discontinuation is investigated in only 1 recent French study . All 4 studies were set in a single country, overall representing data from 3 countries, highlighting the remaining need for generalizable data.…”

Section: Introductionmentioning

confidence: 99%

“…To date, 4 smaller omalizumab survival studies in patients with chronic urticaria have been performed. [11][12][13][14] They showed a decrease in survival rates from 71% to 65% within 1 to 1.5 years 12 and from 77% to 55% within 1 to 3 years, with well-controlled disease as a major reason for discontinuation. 11 These previous studies were limited by small populations (range of sample sizes, 38-298 participants) and short follow-up (range, 32-72 months).…”

mentioning

confidence: 99%

“…11,12,14 Characterization of determinants of discontinuation is investigated in only 1 recent French study. 13 All 4 studies were set in a single country, overall representing data from 3 countries, highlighting the remaining need for generalizable data.…”

mentioning

confidence: 99%

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Multinational Drug Survival Study of Omalizumab in Patients With Chronic Urticaria and Potential Predictors for Discontinuation

Soegiharto,

Alizadeh Aghdam,

Sørensen

et al. 2024

JAMA Dermatol

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ImportanceTreating patients with chronic urticaria using omalizumab has been shown to be safe and effective in randomized clinical trials. Multinational studies on long-term omalizumab performance in chronic urticaria in clinical practice settings are lacking, especially on drug survival. Drug survival, which refers to the length of time that patients are treated with a specific drug, is a comprehensive outcome covering effectiveness, safety, and patient and physician preferences. Furthermore, little is known about the reasons and potential predictors for omalizumab discontinuation.ObjectiveTo investigate omalizumab drug survival as well as reasons and potential predictors for discontinuation in a large, diverse population.Design, Setting, and ParticipantsThis international multicenter cohort study was conducted at 14 Urticaria Centers of Reference and Excellence in 10 countries, including all patients with chronic urticaria from these centers who were ever treated with omalizumab.Main Outcomes and MeasuresDrug survival analysis was performed to assess time to discontinuation. Patient characteristics and treatment protocols were investigated by Cox regression analysis to identify potential predictors for omalizumab discontinuation.ResultsIn 2325 patients with chronic urticaria who started omalizumab between June 2009 and July 2022, the mean (SD) age of the cohort was 42 (6) years, and 1650 participants (71%) were female. Overall omalizumab survival rates decreased from 76% to 39% after 1 to 7 years, respectively (median survival time, 3.3 [95 % CI, 2.9-4.0] years), primarily due to discontinuation from well-controlled disease in 576 patients (65%). Ineffectiveness and adverse effects were reasons for discontinuation in a far smaller proportion of patients, totaling 164 patients (18%) and 31 patients (4%), respectively. Fast treatment response was associated with higher rates of omalizumab discontinuation due to well-controlled disease (hazard ratio, 1.45 [95% CI, 1.20-1.75]), and disease duration of more than 2 years was associated with lower rates of discontinuation due to well-controlled disease (HR, 0.81 [95% CI, 0.67-0.98]). Immunosuppressive cotreatment at the start of omalizumab and autoimmune disease was associated with a higher risk for discontinuation due to ineffectiveness (HR, 1.65 [95% CI, 1.12-2.42]). The presence of spontaneous wheals (HR, 0.62 [95% CI, 0.41-0.93]) and access to higher dosages (HR, 0.40 [95% CI, 0.27-0.58) were both associated with a lower risk for discontinuation of omalizumab due to ineffectiveness.Conclusion and RelevanceThis multinational omalizumab drug survival cohort study demonstrated that treatment of chronic urticaria with omalizumab in a clinical setting is effective and safe, and well-controlled disease is the main reason for treatment discontinuation. These findings on omalizumab drug survival rates and reasons and potential predictors for discontinuation may guide patients and physicians in clinical decision-making and expectation management. These results may call for the identification of biomarkers for chronic urticaria remission in complete responders to omalizumab treatment.

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Section: Discussioncontrasting

confidence: 71%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Multinational Drug Survival Study of Omalizumab in Patients With Chronic Urticaria and Potential Predictors for Discontinuation

Soegiharto,

Alizadeh Aghdam,

Sørensen

et al. 2024

JAMA Dermatol

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Dupilumab for chronic spontaneous urticaria—marvelous or meek?

Mathur,

Rosenberg,

Viswanathan

2024

Journal of Allergy and Clinical Immunology

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Characterization of omalizumab updosing patterns and predictive factors in chronic spontaneous urticaria: A prospective multicentric observational study

Pierrard,

Bernier,

Du‐Thanh

et al. 2024

Allergy

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BackgroundLimited information is available on the use of omalizumab (OMA) updosing since its introduction as a second‐line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management.MethodsWe conducted a prospective, multicentric, real‐life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety.ResultsWe included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9‐month follow‐up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, p < 0.030), a lower lymphocyte count (<2000/mm3, p = 0.037), and low IgE levels (<70 UI/mL, p = 0.024). The side effects of OMA were not more frequent after updosing.ConclusionOne in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels.

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Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study

Cited by 5 publications

References 43 publications

Multinational Drug Survival Study of Omalizumab in Patients With Chronic Urticaria and Potential Predictors for Discontinuation

Multinational Drug Survival Study of Omalizumab in Patients With Chronic Urticaria and Potential Predictors for Discontinuation

Dupilumab for chronic spontaneous urticaria—marvelous or meek?

Characterization of omalizumab updosing patterns and predictive factors in chronic spontaneous urticaria: A prospective multicentric observational study

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