Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort

Namazy, Jennifer A.; Blais, Lucie; Andrews, Elizabeth; Scheuerle, Angela E.; Cabana, Michael D.; Thorp, John M.; Umetsu, Dale T.; Veith, Joachim; Sun, Diana; Kaufman, Derrick; Covington, Deborah L.; Mukhopadhyay, Santanu; Fogel, Robert; López-Léon, Sandra; Spain, C. Victor

doi:10.1016/j.jaci.2019.05.019

Cited by 117 publications

(59 citation statements)

References 31 publications

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“…The study by Namazy et al 1 addressing the important clinical question of the safety of omalizumab (Xolair; Genentech, South San Francisco, Calif) for the mother and fetus when treating asthma during pregnancy is the result of a postmarketing commitment, of the manufacturing company to the US Food and Drug Administration (FDA). Omalizumab is a recombinant IgG 1 anti-IgE mAb used as an add-on drug in patients with moderate-to-severe allergic asthma whose symptoms are not well controlled by other medications.…”

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confidence: 99%

“…Other studies on pregnant asthmatic patients using medications show a slightly increased rate of fetal malformation (odds ratio, 1.11) 10 yet not close to the high rate of malformation found in both populations in the first study by Namazy et al (>8%). 1 This can be explained by the fact that both the EXPECT and the Quebec populations (1) are sicker than the general population, (2) use several medications during pregnancy, and (3) have higher body mass indices, which are all risk factors of increased neonatal malformation rate.…”

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confidence: 99%

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Omalizumab safety in pregnancy

Levi‐Schaffer

Mankuta

2020

Journal of Allergy and Clinical Immunology

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confidence: 99%

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confidence: 99%

Omalizumab safety in pregnancy

Levi‐Schaffer

Mankuta

2020

Journal of Allergy and Clinical Immunology

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“…Omalizumab is currently also used for the treatment of chronic severe urticaria (9). It has also been labelled as a safe drug to be used during pregnancy with no increased risk of major abnormalities between foetuses whose mothers were on treatment with omalizumab and the control group (10). The particularity of the case is that our patient developed SSD after 5 days of spasmolytic treatment with drotaverine, earlier than usual, probably because of the frequent previous administration of the drug.…”

Section: Discussionmentioning

confidence: 83%

A rapid desensitization protocol in a case of drotaverine‑induced serum sickness-like reaction in a pregnant woman: A case report

et al. 2019

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Drotaverine is an antispasmodic drug used to treat gastrointestinal and genitourinary smooth muscle spasms. There are very few hypersensitivity reactions reported. Serum sickness-like disease is an immune-complex-mediated hypersensitivity reaction that presents with some typical features that include rash, fever and articular impairment sometimes associated with liver and renal dysfunctions, beginning 1-2 weeks after exposure to a culprit drug. Diagnosis is a clinical one, made usually on the basis of knowledge obtained by medical history and physical examination. Desensitization usually is recommended for type I reaction, but may be a solution for this type of immunological reaction when other therapeutic alternatives are ineffective or do not exist. We report the case of a 29-year-old pregnant female who developed serum sickness-like reaction after 5 days of daily drotaverine oral administration. The patient required antispasmodic treatment, with this drug, having a pregnancy with an imminent risk of abortion and the other therapeutic alternatives being ineffective. She underwent a rapid 7-step oral drotaverine desensitization protocol without recurrence of serum sickness-like reaction. To our knowledge, this is the first case report of desensitization to drotaverine, previously involved in a serum sickness-like reaction.

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“…Other reasons for withdrawal were diverse, but none of them was worsening of the disease. Although Namazy et al [49,50] proved that the use of omalizumab in pregnant women was safe, we preferred to terminate treatment by a mutual agreement with pregnant women in some centers. The outcomes were not influenced by the fact that non-responders appeared to have more severe disease than other patients ( Table 2).…”

Section: Discussionmentioning

confidence: 99%

Effect of individual allergen sensitization on omalizumab treatment outcomes in patients with severe allergic asthma determined using data from the Czech Anti-IgE Registry

Vanik

Novosad

Kirchnerová

et al. 2020

Allergy Asthma Clin Immunol

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Background Omalizumab is an efficient drug for patients with uncontrolled severe allergic asthma (SAA). However, little is known about the differences in omalizumab treatment outcomes among patients with different types of atopic sensitization. Here, we assessed the effect of sensitization to individual allergens or their combinations on the outcomes of anti-IgE therapy in patients with SAA. Methods We performed a post hoc analysis of data of subgroups of patients enrolled in the Czech Anti-IgE Registry (CAR). The patients were evaluated at baseline and 16 weeks and 12 months after omalizumab treatment initiation. We analyzed the dependence of primary treatment outcomes [global evaluation of treatment effectiveness (GETE) after 16 weeks of treatment, a reduction in severe exacerbation rate (ER), and an improvement in the asthma control test (ACT) result during 12 months of treatment] and secondary outcomes [a reduction in systemic corticosteroid (SCS) use, an improvement in lung functions, and a fraction of exhaled nitric oxide] of patients with SAA treated with omalizumab for 12 months on sensitization to different perennial aeroallergens. We assessed sensitization to house dust mites, molds, and pets at baseline using skin prick tests and/or specific IgE measurement (semiquantitative evaluation). We compared polysensitized patients (sensitized to all tested allergens) with monosensitized (single positivity) or partially polysensitized patients (combined positivity but not to all allergens). Results We enrolled 279 patients (58.3% women, mean age 52.9 years). Omalizumab treatment presented an 82.8% response rate (according to GETE). It significantly reduced severe asthma exacerbations and SCS use, and improved the ACT result in 161 responders. We identified a subgroup of responders with distinct sensitization patterns (polysensitization to all tested perennial allergens) with higher odds of being responders (OR = 2.217, p = 0.02) and lower tendency to improve ACT result (OR 0.398, p = 0.023) and reduce ER (OR 0.431, p = 0.034) than non-polysensitized patients. Conclusions The clinical benefit of sensitization for patients with SAA receiving omalizumab may be particularly dependent on sensitization pattern. Polysensitized patients showed a higher tendency to be responders (GETE), but a lower tendency to improve the ACT result and reduce ER than non-polysensitized patients.

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Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort

Cited by 117 publications

References 31 publications

Omalizumab safety in pregnancy

Omalizumab safety in pregnancy

A rapid desensitization protocol in a case of drotaverine‑induced serum sickness-like reaction in a pregnant woman: A case report

Effect of individual allergen sensitization on omalizumab treatment outcomes in patients with severe allergic asthma determined using data from the Czech Anti-IgE Registry

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