Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

Agache, Ioana; Rocha, Claudio; Pereira, Ana Larisse Carneiro; Song, Yang; Alonso‐Coello, Pablo; Solà, Iván; Beltrán, Jessica; Posso, Margarita; Akdiş, Cezmi A.; Brockow, Knut; Chivato, T.; Giacco, Stefano Del; Eiwegger, Thomas; Eyerich, Kilian; Giménez‐Arnau, Ana; Gutermuth, Jan; Guttman‐Yassky, Emma; Maurer, Marcus; Ogg, Graham S.; Ong, Peck Y.; O’Mahony, Liam; Schwarze, Jürgen; Werfel, Thomas; Canelo‐Aybar, Carlos; Palomares, Óscar; Jutel, Marek

doi:10.1111/all.14547

Cited by 74 publications

(64 citation statements)

References 52 publications

(185 reference statements)

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“…Furthermore, omalizumab decreased (moderate certainty) rescue medication use (MD −2.04; 95% CI −3.19 to −0.88) and drug-related serious adverse events (AEs, RR 0.77; 95% CI 0.20 to 2.91). 21 In contrast, for the 150 mg dose, the minimal important difference (MID) was not reached for any of the observed end-points. 21 It was mentioned that two pharmaceutical companies funded all studies.…”

Section: Resultsmentioning

confidence: 87%

“… 21 In contrast, for the 150 mg dose, the minimal important difference (MID) was not reached for any of the observed end-points. 21 It was mentioned that two pharmaceutical companies funded all studies. 21 …”

Section: Resultsmentioning

confidence: 87%

“…Dosing as recommended within the SPC at 300 mg q4w for at least 3 months is most commonly practised. Whilst the 150 mg dose did not overcome the MID of most endpoints (see above), 21 this dose can be efficacious in individual patients with CSU and CINDU. Regarding updosing to 450 mg or 600 mg q4w in patients that did not respond to the standard dose of 300 mg q4w, a single-dose RCT (MYSTIQUE) demonstrated the safety of up to 600 mg omalizumab q4w.…”

Section: Resultsmentioning

confidence: 91%

“…A very recent systematic review, following the GRADE approach and focusing on licensed omalizumab doses (150 mg and 300 mg/q4w), identified 10 RCTs totalling 1620 subjects with CSU. 21 Treatment duration ranged from 4 to 24 weeks, and the extended follow up without medication ranged from 16 to 40 weeks. Omalizumab 300 mg q4w resulted in clinically relevant improvements (moderate certainty) of the UAS7 (mean difference ((MD)) −11.05; 95% CI −12.87 to −9.24), the ISS7 (MD −4.45; 95% CI −5.39 to −3.51), and DLQI (MD −4.03; 95% CI −5.56 to −2.5, high certainty).…”

Section: Resultsmentioning

confidence: 99%

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Anti-IgE for the Treatment of Chronic Urticaria

Wedi

Traidl

2021

ITT

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Urticaria and angioedema are very common. Management of chronic urticaria subtypes, which usually persist for many years, is challenging. Recent years have demonstrated that targeting IgE with antibodies provides a safe and efficient treatment approach. Whilst several anti-IgE antibodies have been developed, omalizumab is currently the only one approved for use. International and national guidelines recommend its use after failure of antihistamines at standard and increased dose. Whilst not yet approved, many new anti-IgE approaches are currently being investigated in pre-clinical studies or clinical trials. This non-systematic focused review summarizes current knowledge of omalizumab and other anti-IgE biologics in chronic urticaria using data extracted from PubMed, Google Scholar and clinical trial databases, clinicaltrials.gov and clinicaltrials.eu. For adults, there is good evidence from randomized clinical trials and real-world data that symptomatic treatment with omalizumab is efficacious and safe in chronic spontaneous urticaria (CSU), whereas evidence in chronic inducible urticaria (CINDU) and special populations is limited. Easy-to-use tools to identify non-responders and predict the required duration of treatment have not been established yet. Phase 2 b results of ligelizumab have not only demonstrated efficacy and safety but also superiority to omalizumab. Indeed, there is preliminary evidence that omalizumab non- or partial responders benefit from ligelizumab. Whereas further development of quilizumab was discontinued, other approaches, eg UB-221 or DARPins are under investigation. Anti-IgE treatment with omalizumab represents a landmark in the treatment of chronic urticaria, with and without angioedema, and there is light on the horizon suggesting success may come with various next-generation anti-IgE approaches.

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Section: Resultsmentioning

confidence: 87%

Section: Resultsmentioning

confidence: 87%

Section: Resultsmentioning

confidence: 91%

Section: Resultsmentioning

confidence: 99%

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Anti-IgE for the Treatment of Chronic Urticaria

Wedi

Traidl

2021

ITT

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“…Chronic spontaneous urticaria (CSU) is a heterogeneous disorder with recurrent pruritic wheals and angioedema or both that markedly affects patients' quality of life (1,2). The anti-IgE antibody omalizumab is used in CSU patients resistant to antihistamine treatment (3).…”

Section: Introductionmentioning

confidence: 99%

Case Report: Omalizumab for Chronic Spontaneous Urticaria in Pregnancy

Liao

Zhao

et al. 2021

Front. Immunol.

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Most chronic spontaneous urticaria (CSU) patients are female, and pregnancy can aggravate the disease activity of patients, but little is known about the efficacy and safety of omalizumab in pregnant CSU patients. We report two pregnant CSU patients treated with omalizumab and review the published information on omalizumab treatment during 11 pregnancies. The outcomes reported on patients with known pregnancies showed they had normal pregnancies and healthy babies as well as complete control of their CSU. The two new cases we reported support the view that omalizumab could be an effective and safe treatment option for pregnant and breastfeeding CSU patients. Further high-quality studies need to be carried out in order to obtain more information on the long-term efficacy and safety of the use of omalizumab during pregnancy in patients with chronic urticaria, including CSU.

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Evaluation of Pharmacologic Treatments for H₁ Antihistamine–Refractory Chronic Spontaneous Urticaria

et al. 2021

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IMPORTANCEThe comparative benefits and harms of all available treatments for H 1 antihistamine-refractory chronic spontaneous urticaria (CSU) have not been established. OBJECTIVE To evaluate different treatment effects of pharmacologic treatments among patients with H 1 antihistamine-refractory CSU.DATA SOURCES Searches were conducted of MEDLINE, Embase, PubMed, Cochrane Library, Web of Science, Scopus, and CINAHL from inception to April 19, 2021, with no language restrictions. Gray literature from Google Scholar, ongoing trial registers, and preprint reports was added to the searches of electronic databases.STUDY SELECTION Randomized clinical trials using validated measurement tools that investigated the benefits and harms of pharmacologic treatments among adolescent or adult patients with CSU who had an inadequate response to H 1 antihistamines were screened for inclusion independently by 2 investigators. DATA EXTRACTION AND SYNTHESISTwo investigators independently extracted study data according to the predefined list of interests. A random-effects model was used to calculate the network estimates reported as standardized mean differences and odds ratios with corresponding 95% CIs. MAIN OUTCOMES AND MEASURESThe primary outcomes that reflect the patient's perspective included changes in urticaria symptoms from baseline and unacceptability of treatment (all-cause dropouts).RESULTS Twenty-three randomized clinical trials with 2480 participants that compared 18 different interventions or dosages and placebo were included. The standardized mean differences for change in urticaria symptoms were −1.05 (95% CI, −1.37 to −0.73) for ligelizumab, 72 mg; −1.07 (95% CI, −1.39 to −0.75) for ligelizumab, 240 mg; −0.77 (95% CI, −0.91 to −0.63) for omalizumab, 300 mg; and −0.59 (95% CI, −1.10 to −0.08) for omalizumab, 600 mg. No significant differences in treatment unacceptability were observed. With respect to benefits and harms, the network estimates illustrated that the most efficacious treatments were achieved with ligelizumab, 72 or 240 mg (large beneficial effect) and omalizumab, 300 or 600 mg (moderate beneficial effect). CONCLUSIONS AND RELEVANCEThe findings in this meta-analysis suggest that the biologic agents ligelizumab, 72 or 240 mg, and omalizumab, 300 or 600 mg, can be recommended as effective treatments for patients with CSU who have had an inadequate response to H 1 antihistamines. Head-to-head trials with high methodologic quality and harmonized design and outcome definitions are needed to help inform subsequent international guidelines for the management of CSU.

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Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

Cited by 74 publications

References 52 publications

Anti-IgE for the Treatment of Chronic Urticaria

Anti-IgE for the Treatment of Chronic Urticaria

Case Report: Omalizumab for Chronic Spontaneous Urticaria in Pregnancy

Evaluation of Pharmacologic Treatments for H₁ Antihistamine–Refractory Chronic Spontaneous Urticaria

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Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines

Cited by 74 publications

References 52 publications

Anti-IgE for the Treatment of Chronic Urticaria

Anti-IgE for the Treatment of Chronic Urticaria

Case Report: Omalizumab for Chronic Spontaneous Urticaria in Pregnancy

Evaluation of Pharmacologic Treatments for H1 Antihistamine–Refractory Chronic Spontaneous Urticaria

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Evaluation of Pharmacologic Treatments for H₁ Antihistamine–Refractory Chronic Spontaneous Urticaria