A randomized double-blind, placebo-controlled study of omalizumab for idiopathic anaphylaxis - 04/03/21
, Irina Maric, MD b, Erica H. Brittain, PhD c, Yun Bai, BS a, Keith Lumbard, BS d, Hyejeong Bolan, BSN a, Daly Cantave, MSN e, Linda M. Scott, NP a, Dean D. Metcalfe, MD aAbstract |
Background |
Idiopathic anaphylaxis (IA) is a diagnosis of exclusion, thus taking away the option of therapeutic management focused on eliminating the inciting agent. Epinephrine and antihistamines followed by systemic corticosteroids are the mainstays of therapy for acute events. There is no prophylactic therapy that reliably prevents anaphylaxis.
Objective |
We sought to determine the efficacy of omalizumab in the management of patients with frequent episodes of IA in a double-blind, placebo-controlled trial.
Methods |
We prospectively enrolled 19 patients with frequent IA (≥6 episodes/y) who then underwent a medical evaluation that included a serum tryptase determination, mutational analysis for KIT D816V, and bone marrow evaluation to rule out a clonal mast cell disorder. Computer-generated random numbers were provided by the study pharmacist. The primary end point was anaphylactic events in the 6 months after baseline. Sixteen patients completed the primary trial.
Results |
No statistically significant difference was demonstrated between the placebo and treated groups. There was a trend for efficacy in the treatment group, particularly after 60 days. Overall, the safety profile was favorable without long-term side effects.
Conclusions |
Omalizumab was safely administered to a difficult-to-treat patient population with IA. The efficacy results trended modestly in favor of the treatment group, but no statistically significant differences were detected.
Il testo completo di questo articolo è disponibile in PDF.Key words : Idiopathic anaphylaxis, omalizumab, randomized, therapy
Abbreviations used : DBPC, IA, NIH
Mappa
| This work was supported by the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health. This project has been funded in part with federal funds from the National Cancer Institute, National Institutes of Health (under contract no. 75N91019D00024, task order no. 75N91019F00130). The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government. |
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| Disclosure of potential conflict of interest: The authors declare that they have no relevant conflicts of interest. |
Vol 147 - N° 3
P. 1004 - Marzo 2021 Ritorno al numero
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