Safety Profile of Dual Biologic Therapy with Omalizumab and a Second Biologic Agent

Cherian, Sheeba; Константинова, Т. Н.; Hu, Jinxiang; Khan, Sadia Hayat

doi:10.1016/j.jaci.2019.12.301

Cited by 2 publications

(2 citation statements)

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“…The literature describing the use of dual biologics for these or other overlapping conditions is currently limited to 16 articles identified by our search (Table 3). [31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47] In total, these articles summarize 45 patients on dual biologic therapy. The search did not reveal any randomized controlled trials to date, but are currently 12 case reports, 2 case series and 2 retrospective reviews.…”

Section: Pulmonology/allergymentioning

confidence: 99%

Review of Dual Biologics in Specialty Pharmacy Practice

Quiroga

Sabourin

2023

Ann Pharmacother

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Objective: To describe and review the published evidence on use of multiple biologics within specialty pharmacy practice. Data Sources: A search of PubMed and Embase was conducted from October 2021 through September 2022. Keywords included biologics for immune-mediated conditions along with the terms “dual,” “add-on,” and “combination.” Study Selection and Data Extraction: All human studies in the English language were considered. Published abstracts, case reports, case series, randomized controlled trials, systematic reviews, and meta-analyses were included. Data Synthesis: Although evidence is limited, there are published meta-analyses of combined biologic use within gastroenterology and rheumatology. There are also numerous case reports within dermatology. Clinical trials of dual biologics for severe rheumatologic conditions and inflammatory bowel disease are in progress. Existing evidence for use in pulmonology and allergy suggest dual biologic therapy can be safe and effective, but data are limited. Literature describing use of monoclonal antibodies for other overlapping conditions is lacking. Relevance to Patient Care and Clinical Practice: This article reviews the evidence describing combination biologic use and outlines remaining knowledge gaps. It also describes the essential role that specialty pharmacists play in managing therapeutic mAbs. Conclusions: High-quality evidence describing combination biologic use is limited and long-term safety data are lacking. Pharmacists should utilize their specialized training to assess appropriateness of therapy, provide patient counseling and monitor for safety and efficacy.

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Section: Pulmonology/allergymentioning

confidence: 99%

Review of Dual Biologics in Specialty Pharmacy Practice

Quiroga

Sabourin

2023

Ann Pharmacother

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“…Despite the limited number of reports in CSU [76], future studies with AE angioedema, AE-QoL Angioedema Quality-Of-Life Questionnaire, CU-Q2oL Chronic Urticaria Quality-Of-Life Questionnaire, DLQI Dermatology Life-Quality Index, HS7 weekly number of hives score, ISS7 weekly itch score, N number of patients, N/A not available, OMA omalizumab, QoL quality of life, UAS7 Urticaria Activity Score over 7 days *p < 0.05 [48,49] Low total IgE levels [48,49] Very low total IgE levels [51] Very high overexpression levels of FcεRI on basophils [47,50] Lower ratio of 4th week/baseline IgE [49] Lower expression levels of FcεRI on basophils than fast responders but always increased compared with healthy controls [50] Very low expression of FcεRI on basophils even lower than healthy controls are shown by non-responders [47,50] Autoallergens to be assessed Eosinopenia and basopenia [172] larger sample sizes and longer durations of follow-up are needed. Furthermore, the concurrent use of omalizumab with other biologics did not cause any increase in infections or laboratory abnormalities [77]. Larger studies in patients with asthma and case series of CSU showed no increase of major congenital abnormalities with the use of omalizumab during pregnancy [78][79][80].…”

Section: Omalızumab: From Development To Current Challengesmentioning

confidence: 99%

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

Giménez‐Arnau

Salman

2020

Drugs

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Chronic spontaneous urticaria (CSU) is characterized by the presence of wheals, angioedema, or both for at least 6 weeks. It may persist for a long time-up to 50% of the patients have been reported to be symptomatic 5 years after the onset. Some patients can suffer more than one episode of CSU during their lifetime. Considering the recurrences, disabling symptoms, and significant impact on quality of life, proper and effective treatment of CSU is critical. The use of antihistamines (AHs) is still the mainstay of treatment. However, given the low rates of response to AHs (38.6% and 63.2% to standard doses and higher doses, respectively), the complete control of symptoms seems difficult to attain. The use of omalizumab for CSU has been a major breakthrough in the care of patients with CSU. However, the partial response and lack of response to omalizumab in a subgroup of patients, as high as 70% in some studies, make the development of alternative treatments desirable. Ever-increasing knowledge on the pathogenesis is making new target molecules available and enabling drug development for CSU. In addition to drug repurposing as in anti-IL-4/13, IL-5, and IL-17 antibodies, novel targeted therapy options such as ligelizumab and Bruton's tyrosine kinase inhibitors are currently undergoing clinical trials and will be available in the near future. This article reviews the current challenges in the treatment of CSU, the pathogenesis and potential target molecules, and the rationale for novel treatments and their rapidly developing status.

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Safety Profile of Dual Biologic Therapy with Omalizumab and a Second Biologic Agent

Cited by 2 publications

References 0 publications

Review of Dual Biologics in Specialty Pharmacy Practice

Review of Dual Biologics in Specialty Pharmacy Practice

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

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