Ligelizumab for the treatment of chronic spontaneous urticaria

References

• 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. Allergy. 2018 Jul 01;73(7):1393–1414.
   PubMed Web of Science ®Google Scholar
• Wedi B. Urticaria and angioedema. In: Plewig G, French L, Ruzicka T, et al., editors. Braun-Falco’s Dermatologe. Berlin, Heidelberg: Springer Germany; 2020:1–26.
   Google Scholar
• Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol. 2008 Mar 01;8(3):205–217.
   PubMed Web of Science ®Google Scholar
• Gomez G. Current strategies to inhibit high affinity FcepsilonRI-mediated signaling for the treatment of allergic disease. Front Immunol. 2019 Feb 07;10:175.
   PubMed Web of Science ®Google Scholar
• Maurer M, Rosen K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 07;368(10):924–935.
   PubMed Web of Science ®Google Scholar
• 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 Jan 01;155(1):29–38.
   PubMed Web of Science ®Google Scholar
• Urgert MC, van den Elzen MT, Knulst AC, et al. Omalizumab in patients with chronic spontaneous urticaria: a systematic review and GRADE assessment. Br J Dermatol. 2015 Aug 01;173(2):404–415.
   PubMed Web of Science ®Google Scholar
• Dressler C, Werner RN, Eisert L, et al. Chronic inducible urticaria: a systematic review of treatment options. J Allergy Clin Immunol. 2018 May 01;141(5):1726–1734.
   PubMed Web of Science ®Google Scholar
• Maurer M, Metz M, Brehler R, et al. Omalizumab treatment in patients with chronic inducible urticaria: a systematic review of published evidence. J Allergy Clin Immunol. 2018 Feb 01;141(2):638–649.
   PubMed Web of Science ®Google Scholar
• Schoepke N, Asero R, Ellrich A, et al. Biomarkers and clinical characteristics of autoimmune chronic spontaneous urticaria: results of the PURIST study. Allergy. 2019 Dec 01;74(12):2427–2436.
   PubMed Web of Science ®Google Scholar
• Maurer M, Altrichter S, Schmetzer O, et al. Immunoglobulin E-mediated autoimmunity. Front Immunol. 2018 Apr;9(9):689.
   PubMedGoogle Scholar
• Ferrer M, Gimenez-Arnau A, Saldana D, et al. Predicting chronic spontaneous urticaria symptom return after omalizumab treatment discontinuation: exploratory analysis. J Allergy Clin Immunol Pract. 2018 Aug 01;6(4):1191, 1197.e5.
   PubMed Web of Science ®Google Scholar
• Turk M, Maurer M, Yilmaz I. How to discontinue omalizumab in chronic spontaneous urticaria? Allergy. 2019 Apr 01;74(4):821–824.
   PubMed Web of Science ®Google Scholar
• Arm JP, Bottoli I, Skerjanec A, et al. Pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity anti-IgE antibody, in atopic subjects. Clin Exp Allergy. 2014 Nov;44(11):1371–1385.
   PubMed Web of Science ®Google Scholar
• Maurer M, Gimenez-Arnau AM, Sussman G, et al. Ligelizumab for chronic spontaneous urticaria. N Engl J Med. 2019 Oct 3;381(14):1321–1332.
   PubMed Web of Science ®Google Scholar
• Johansson SG, Haahtela T, O’Byrne PM. Omalizumab and the immune system: an overview of preclinical and clinical data. Ann Allergy Asthma Immunol. 2002 Aug 01;89(2):132–138.
   PubMed Web of Science ®Google Scholar
• Ledford DK. Omalizumab: overview of pharmacology and efficacy in asthma. Expert Opin Biol Ther. 2009 Jul;9(7):933–943.
   PubMed Web of Science ®Google Scholar
• Kowal K, Bielecki P, DuBuske IV, et al. In vitro impact of anti-immunoglobulin E monoclonal antibodies, including omalizumab on whole blood basophil histamine release: assessment of direct induction of basophil histamine release and evaluation of modulation of allergen-induced basophil histamine release. Allergy Asthma Proc. 2017 May 01;38(3):204–215.
   PubMed Web of Science ®Google Scholar
• Gasser P, Tarchevskaya SS, Guntern P, et al. The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab. Nat Commun. 2020 Jan 08;11(1):165–w.
   PubMed Web of Science ®Google Scholar
• Jensen RK, Jabs F, Miehe M, et al. Structure of intact IgE and the mechanism of ligelizumab revealed by electron microscopy. Allergy. 2020 Feb 09. DOI:10.1111/all.14222.
   Web of Science ®Google Scholar
• Pennington LF, Tarchevskaya S, Brigger D, et al. Structural basis of omalizumab therapy and omalizumab-mediated IgE exchange. Nat Commun. 2016 May 19;7:11610.
   PubMed Web of Science ®Google Scholar
• Selb R, Eckl-Dorna J, Twaroch TE, et al. Critical and direct involvement of the CD23 stalk region in IgE binding. J Allergy Clin Immunol. 2017 Jan 01;139(1):281, 289.e5.
   PubMed Web of Science ®Google Scholar
• Davies AM, Allan EG, Keeble AH, et al. Allosteric mechanism of action of the therapeutic anti-IgE antibody omalizumab. J Biol Chem. 2017 Jun 16;292(24):9975–9987.
   PubMed Web of Science ®Google Scholar
• Gauvreau GM, Arm JP, Boulet LP, et al. Efficacy and safety of multiple doses of QGE031 (ligelizumab) versus omalizumab and placebo in inhibiting allergen-induced early asthmatic responses. J Allergy Clin Immunol. 2016 Oct;138(4):1051–1059.
   PubMed Web of Science ®Google Scholar
• Xolair [Internet]; [cited 2020 Mar 22]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/xolair.
   Google Scholar
• Busse W, Buhl R, Fernandez Vidaurre C, et al. Omalizumab and the risk of malignancy: results from a pooled analysis. J Allergy Clin Immunol. 2012 Apr 01;129(4):983, 9.e6.
   PubMed Web of Science ®Google Scholar
• Cruz AA, Lima F, Sarinho E, et al. Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection. Clin Exp Allergy. 2007 Feb 01;37(2):197–207.
   PubMed Web of Science ®Google Scholar
• 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 Jul 01;69(7):868–887.
   PubMed Web of Science ®Google Scholar
• Kaplan AP, Gimenez-Arnau AM, Saini SS. Mechanisms of action that contribute to efficacy of omalizumab in chronic spontaneous urticaria. Allergy. 2017Apr01;72(4):519–533.
   PubMed Web of Science ®Google Scholar
• Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015 Mar 01;135(3):925.
   PubMed Web of Science ®Google Scholar
• Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013 July 01;132(1):101–109.
   PubMed Web of Science ®Google Scholar
• Maurer M, Altrichter S, Bieber T, et al. Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. J Allergy Clin Immunol. 2011 Jul 01;128(1):202, 209.e5.
   PubMed Web of Science ®Google Scholar
• Lapeere H, Baeck M, Stockman A, et al. A retrospective analysis omalizumab treatment patterns in patients with chronic spontaneous urticaria: a real-world study in belgium. J Eur Acad Dermatol Venereol. 2020 Jan 01;34(1):127–134.
   PubMed Web of Science ®Google Scholar
• Salman A, Ergun T, Gimenez-Arnau AM. Real-life data on the effectiveness and safety of omalizumab in monotherapy or combined for chronic spontaneous urticaria: a retrospective cohort study. J Dermatolog Treat. 2020 Mar 01;31(2):204–209.
   PubMed Web of Science ®Google Scholar
• Weller K, Ohanyan T, Hawro T, et al. Total IgE levels are linked to the response of chronic spontaneous urticaria patients to omalizumab. Allergy. 2018 Dec 01;73(12):2406–2408.
   PubMed Web of Science ®Google Scholar
• Ertas R, Ozyurt K, Atasoy M, et al. The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change. Allergy. 2018 Mar 01;73(3):705–712.
   PubMed Web of Science ®Google Scholar
• Deza G, Bertolin-Colilla M, Sanchez S, et al. Basophil FcvarepsilonRI expression is linked to time to omalizumab response in chronic spontaneous urticaria. J Allergy Clin Immunol. 2018 Jun 01;141(6):2313, 2316.e1.
   PubMed Web of Science ®Google Scholar
• Deza G, March-Rodriguez A, Sanchez S, et al. Relevance of the basophil high-affinity IgE receptor in chronic urticaria: clinical experience from a tertiary care institution. J Allergy Clin Immunol Pract. 2019 Jun 01;7(5):1619, 1626.e1.
   PubMed Web of Science ®Google Scholar
• Maurer M, Magerl M. How to control recurrent angioedema using monoclonal antibody therapies? Expert Opin Biol Ther. 2020 Jan 01;20(1):1–4.
   PubMed Web of Science ®Google Scholar
• Staubach P, Metz M, Chapman-Rothe N, et al. Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data. Allergy. 2018 Mar 01;73(3):576–584.
   PubMed Web of Science ®Google Scholar
• Sabroe RA. Ligelizumab for chronic spontaneous urticaria. Br J Dermatol. 2020 Jan 30. DOI:10.1111/bjd.18901 (online ahead of print).
   PubMed Web of Science ®Google Scholar
• Alizadeh Aghdam M, van den Broek F, Rijken F, et al. High-dose omalizumab use in patients with chronic spontaneous urticaria. J Allergy Clin Immunol Pract. 2020;8:1426-1427.
   PubMed Web of Science ®Google Scholar
• Neverman L, Weinberger M. Treatment of chronic urticaria in children with antihistamines and cyclosporine. J Allergy Clin Immunol Pract. 2014 Aug 01;2(4):434–438.
   PubMed Web of Science ®Google Scholar
• Kulthanan K, Chaweekulrat P, Komoltri C, et al. Cyclosporine for chronic spontaneous urticaria: a meta-analysis and systematic review. J Allergy Clin Immunol Pract. 2018 Apr 01;6(2):586–599.
   PubMed Web of Science ®Google Scholar
• Sanchez J, Alvarez L, Cardona R. Cyclosporine and omalizumab together: A new option for chronic refractory urticaria. J Allergy Clin Immunol Pract. 2020 Feb 26. DOI:10.1016/j.jaip.2020.02.012.
   Web of Science ®Google Scholar
• Kolkhir P, Altrichter S, Munoz M, et al. New treatments for chronic urticaria. Ann Allergy Asthma Immunol. 2020 Jan 01;124(1):2–12.
   PubMed Web of Science ®Google Scholar
• Maurer M, Schutz A, Weller K, et al. Omalizumab is effective in symptomatic dermographism-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017 Sep 01;140(3):870, 873.e5.
   PubMed Web of Science ®Google Scholar
• Altrichter S, Chuamanochan M, Knoth H, et al. Real-life treatment of cholinergic urticaria with omalizumab. J Allergy Clin Immunol. 2019 Feb 01;143(2):788, 791.e8.
   PubMed Web of Science ®Google Scholar
• Gastaminza G, Azofra J, Nunez-Cordoba JM, et al. Efficacy and safety of omalizumab (xolair) for cholinergic urticaria in patients unresponsive to a double dose of antihistamines: a randomized mixed double-blind and open-label placebo-controlled clinical trial. J Allergy Clin Immunol Pract. 2019 Jun 01;7(5):1599, 1609.e1.
   PubMed Web of Science ®Google Scholar
• Metz M, Schutz A, Weller K, et al. Omalizumab is effective in cold urticaria-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017 Sep 01;140(3):864, 867.e5.
   PubMed Web of Science ®Google Scholar
• Bullerkotte U, Wieczorek D, Kapp A, et al. Effective treatment of refractory severe heat urticaria with omalizumab. Allergy. 2010 July 01;65(7):931–932.
   PubMed Web of Science ®Google Scholar
• Carballada F, Nunez R, Martin-Lazaro J, et al. Omalizumab treatment in 2 cases of refractory heat urticaria. J Investig Allergol Clin Immunol. 2013;23(7):519–521.
   PubMed Web of Science ®Google Scholar
• Snast I, Kremer N, Lapidoth M, et al. Omalizumab for the treatment of solar urticaria: case series and systematic review of the literature. J Allergy Clin Immunol Pract. 2018 Aug 01;6(4):1198, 1204.e3.
   PubMed Web of Science ®Google Scholar
• Yu C, Wang K, Cui X, et al. Clinical efficacy and safety of omalizumab in the treatment of allergic rhinitis: a systematic review and meta-analysis of randomized clinical trials. Am J Rhinol Allergy. 2020 Mar 01;34(2):196–208.
   PubMed Web of Science ®Google Scholar
• Dantzer JA, Wood RA. The use of omalizumab in allergen immunotherapy. Clin Exp Allergy. 2018 Mar 01;48(3):232–240.
   PubMed Web of Science ®Google Scholar
• Bachert C, Zhang N, Cavaliere C, et al. Biologics for chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2020 Mar 01;145(3):725–739.
   PubMed Web of Science ®Google Scholar
• Jendoubi F, Gaudenzio N, Gallini A, et al. Omalizumab in the treatment of adult patients with mastocytosis: a systematic review. Clin Exp Allergy. 2020 Feb 27. DOI:10.1111/cea.13592.
   PubMed Web of Science ®Google Scholar
• Kremer N, Snast I, Cohen ES, et al. Rituximab and omalizumab for the treatment of bullous pemphigoid: a systematic review of the literature. Am J Clin Dermatol. 2019 Apr 01;20(2):209–216.
   PubMed Web of Science ®Google Scholar
• Hasni S, Gupta S, Davis M, et al. Safety and tolerability of omalizumab: a randomized clinical trial of humanized anti-IgE monoclonal antibody in systemic lupus erythematosus. Arthritis Rheumatol. 2019 Jul 01;71(7):1135–1140.
   PubMed Web of Science ®Google Scholar
• Kafi P, Eden I, Swartling C. Morbihan syndrome successfully treated with omalizumab. Acta Derm Venereol. 2019 Jun 01;99(7):677–678.
   PubMed Web of Science ®Google Scholar