Table 1.
Record of malignancy in trials about Omalizumab in asthma, urticaria and chronic rhinosinusitis.
| Disease | Reference | Year | Objective of the trial | Evaluated Sample | Effect on malignancy |
|---|---|---|---|---|---|
| ASTHMA | Rodrigo GJ et al. Chest. 2011; 139(1):28-35 | 2011 | Establish the efficacy and safety of subcutaneous OMA as add-on therapy to corticosteroids | 3429 patients in 8 studies. Systematic review of placebo-controlled studies | No increased risk of malignancy |
| ASTHMA | Tzortzaki EG et al. Pulm Pharmacol Ther. 2012; 25(1):77-82 | 2011 | Evaluate the 4 months, 1- and 4-year effectiveness of OMA treatment, in a non-interventional, observational “real-life” study | 60 patients with severe persistent allergic asthma | – |
| ASTHMA | Vennera MDC et al. Spanish Registry. J Asthma. 2012; 49(4):416-22 | 2012 | Evaluate the efficacy and tolerability of OMA in a real-life setting in Spain, particularly in those patients with immunoglobulin E (IgE) levels out of range. Follow-up time- 2 years | 266 uncontrolled severe asthma patients receiving high-dose inhaled corticosteroids plus long-acting β2-agonist were recruited | – |
| ASTHMA | Busse W et al. J Allergy Clin Immunol. 2012; 129(4):983-9.e6 | 2012 | Examine the incidence of malignancy using comprehensive pooled data from clinical trials of OMA-treated patients | 11,459 patients in 67 phase I to IV clinical trials | 25 patients with malignancy in RDBPC trials: 14/4254 (0.33%) treated with OMA 11/3178 (0.35%) treated with placebo Incidence rates per 1000 patient-years of observation time for OMA- and placebo-treated patients were 4.14 (95% CI, 2.26–6.94) and 4.45 (95% CI, 2.22–7.94) |
| ASTHMA | Long A et al. J Allergy Clin Immunol. 2014; 134(3):560–567.e4 | 2014 | Evaluate long-term safety in OMA-treated and non-OMA-treated patients | 4393 patients (>12 years of age) with moderate-to-severe allergic asthma in a prospective observational cohort study | No increased risk of malignancy |
| ASTHMA | Li J et al. J Allergy Clin Immunol. 2015; 135(1):289 | 2015 | Highlight on malignancy in EXCELS study | No increased risk of malignancy | |
| ASTHMA | Rodrigo GJ et al.Pediatr Allergy Immunol. 2015; 26(6):551-6 | 2015 | Establish the efficacy and safety of subcutaneous OMA as an add-on therapy | 1381 patients in three randomized controlled trials | No increased risk of malignancy |
| ASTHMA | Di Bona D et al. Respir Med. 2017; 130:55–60 | 2017 | Assess the safety of OMA in patients under long-term treatment in a real-life setting | 91 difficult-to-control asthmatic patients treated with OMA up to 9 years were retrospectively evaluated | No increased risk of malignancy |
| ASTHMA | Sousa J et al. Expert Opin Drug Saf. 2020; 19(1):99-106 | 2020 | Characterize the safety profile of biologicals used in asthma | Retrospective and descriptive analysis of spontaneous reports involving OMA and mepolizumab, sent to the Portuguese Pharmacovigilance System, since market launch until October 2018 | |
| ASTHMA and URTICARIA | Ali Z et al. Br J Dermatol. 2022; 186(4):746-748 | 2022 | Evaluation of OMA and cancer risk association | 1444 patients treated with OMA both for urticaria and asthma | No increased risk of malignancy both in asthma and urticaria |
| URTICARIA | Metz M et al. Curr Opin Allergy Clin Immunol. 2012; 12(4):406-11 | 2012 | Summarize and discuss all published information on the use of OMA in urticaria | 225 patients (209 with asthma and 16 with urticaria) | – |
| URTICARIA | Kaplan A et al. J Allergy Clin Immunol. 2013; 132(1):101-9 | 2013 | To evaluate the safety and efficacy of 24-week treatment with OMA in patients with persistent CIU/CSU | 336 patients enrolled in a phase III study, on a 16 week period of observation | No increased risk of malignancy |
| URTICARIA | Chicharro P et al. Actas Dermosifiliogr. 2017; 108(5):423-431 | 2016 | Analyze the most important aspects of the cases and the outcomes reported | This review brings together case reports and case series describing the use of OMA to treat chronic inducible urticaria | – |
| URTICARIA | Tharp MD et al. JAMA Dermatol. 2019; 155(1):29-38 | 2018 | Analyze benefits and harms of OMA in the real-world clinical management of CIU regarding urticaria activity, treatment response, and adverse events | 294 patients described in observational studies (January 1, 2006, to January 1, 2018) and scientific abstracts on the effectiveness of OMA in CIU | – |
| URTICARIA | Bernstein JA et al. Expert Opin Biol Ther. 2018; 18(4):425-448 | 2018 | Provide a synthesis of evidence and opinion on the use of OMA across the diverse patient phenotypes affected by CIU/CSU. | Review of 84 observational effectiveness studies covers treatments (dosing, medication use), clinical outcomes (treatment response, disease activity, quality of life), and safety | – |
| URTICARIA | Maurer M et al. J Allergy Clin Immunol. 2018; 141(2):638-649 | 2018 | Determine the strength of evidence for OMA efficacy and safety in the treatment of chronic inducible urticarias, symptomatic dermographism, cold urticaria, delayed-pressure urticaria, solar urticaria, heat urticaria, vibratory angioedema, cholinergic urticaria, contact urticaria, and aquagenic urticaria | Systematic review of 43 trials, case studies, case reports, and analyses | – |
| URTICARIA and Athopic Asthma | Johnston A et al. Clin Exp Allergy. 2019; 49(10):1291-1305 | 2019 | Investigate whether prolonged treatment with OMA influences development or progression of solid epithelial cancer in patients with atopic asthma or CIU | 11,758 patients from 12 studies in a systematic review and meta-analysis of intervention and observational studies | No increased risk of malignancy between patients treated with OMA compared to standard of care (Peto OR: 0.65, 95% CI: 0.11, 3.74, I2 = 41%). In comparative study, the risk of solid epithelial tumor was OMA: 2.3%, standard of care: 2.2%, p = N.S. |
| URTICARIA | Metz M et al. Clin Rev Allergy Immunol. 2020; 59(1):38–45. | 2020 | Provide an overview of studies and the real-world data on OMA up-dosing as it became necessary to obtain complete CSU symptom control in a proportion of patients. | 1207 patients from observational studies (from June 2003 to October 2019) on the up-dosing of OMA in CSU | – |
| URTICARIA | Agache J et al. Allergy. 2021; 76(1):59-70 | 2021 | Evaluate the efficacy and safety of OMA for CSU | 2126 patients in 11 randomized controlled trials | – |
| RHYNOSINUSITIS | Gevaert P et al. J Allergy Clin Immunol. 2020; 146(3):595-605 | 2019 | Determine OMA safety/efficacy in CRSwNP in phase III trials (POLYP 1, POLYP 2). | 265 adults with CRSwNP and with an inadequate response to intranasal corticosteroids were randomized (1:1) to OMA or placebo and intranasal mometasone for 24 weeks | – |
| RHYNOSINUSITIS | Chong LY et al. Cochrane Database Syst Rev. 2020; 2(2):CD013513 | 2020 | Assess the effects of biologics for the treatment of chronic rhinosinusitis | 1262 patients analyzed by a Cochrane ENT Information Specialist | – |
| RHYNOSINUSITIS | Wu Q et al. BMJ Open. 2021; 11(9):e047344 |
2021 | Assess the efficacy and safety of OMA for CRSwNP | 302 patients from 3 trials in a meta-analyses | – |
| RHYNOSINUSITIS | Agache J et al. Allergy. 2021; 76(8):2337-2353 | 2021 | Evaluate the efficacy and safety of biologicals for CRSwNP, compared with the standard of care | Systemic review of 303 patients treated with OMA | – |
OMA: omalizumab; RDBPC: randomized double-blind placebo-controlled; CIU: chronic idiopathic urticaria; CSU: chronic spontaneous urticaria; CRSwNP: chronic rhinosinusitis with nasal polyposis