15 years of allergen immunotherapy vial sterility testing

Hernandez, Camellia; Waibel, Kirk H.; Kosisky, Susan E.; Nelson, Michael R.; Banks, Taylor A.

doi:10.1016/j.anai.2016.12.004

Cited by 5 publications

(3 citation statements)

References 6 publications

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“…9 To date, AIT sterility studies have failed to identify a measurable risk of contamination in extracts prepared using recommended aseptic techniques. [10][11][12][13] Retrospective clinical studies of patients undergoing AIT have similarly not found any evidence of infection risk from AIT. 6,14 There are no case reports of AIT-induced infections in the medical literature.…”

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confidence: 99%

Mining social media data to assess the risk of skin and soft tissue infections from allergen immunotherapy

Blumenthal

Topaz

Zhou

et al. 2019

Journal of Allergy and Clinical Immunology

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Background: Allergen immunotherapy (AIT) treatment for allergic rhinitis and asthma is used by 2.6 million Americans annually. Clinical and sterility testing studies identify no risk of contamination or infection from extracts prepared using recommended aseptic techniques, but regulatory concerns persist. Social media can be used to investigate rare adverse effects not captured by traditional studies. Objective: We sought to investigate large social media databases for suggestion of AIT skin and soft tissue infection (SSTI) risk and compare this risk to a comparator procedure with a sterile pharmaceutical. Methods: We analyzed US-restricted data from more than 10 common text-based social media platforms including Facebook, Twitter, and Reddit between 2012 and 2016. We used natural language processing (NLP) to identify posts related to AIT and, separately, influenza vaccination (comparator procedure). NLP was followed by manual review to identify posts suggesting a possible SSTI associated with either AIT or influenza vaccination. SSTI frequencies with 95% CIs were compared. Results: We identified 25,126 AIT posts, which were matched by social media platform to 25,126 influenza vaccination-related posts. NLP identified 4088 (16.3%) AIT posts that required manual review, with 6 posts (0.02%; 95% CI, 0.005%-0.043%) indicative of possible AIT-related SSTI. NLP identified 2689 (10.7%) influenza posts that required manual review, with 7 posts (0.03%; 95% CI, 0.007%-0.048%) indicative of possible influenza vaccination-related SSTI. Conclusions: Social media data suggest that SSTI from AIT and influenza vaccination are equally rare events. Given that AIT's SSTI risk appears comparable to the risk using a sterile pharmaceutical based on social media data, current aseptic technique procedures seem safe.

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confidence: 99%

Mining social media data to assess the risk of skin and soft tissue infections from allergen immunotherapy

Blumenthal

Topaz

Zhou

et al. 2019

Journal of Allergy and Clinical Immunology

View full text Add to dashboard Cite

show abstract

“…The USACAEL prepares most allergen extracts for all branches of the military. 16 In addition, the USACAEL also supplies extracts to the Veterans Health Administration, as well as to civilian practices. 15 …”

Section: Methodsmentioning

confidence: 99%

“… 1 , 13 , 14 For all branches of the military served by MHS facilities, most allergen extract preparations, including VIT extracts, are generated by the US Army Centralized Allergen Extract Laboratory (USACAEL). 15 , 16 A significant portion of military personnel reside and train in IFA-endemic regions; avoidance of IFAs in endemic areas is extremely difficult; thus, management of patients with IFA hypersensitivity should center on IFA VIT. 15 IFA VIT is therefore a significant military readiness subject.…”

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confidence: 99%