#SaveAllergyShots - sign the petition on Change.org now!

Allergen immunotherapy was introduced by Leonard Noon 100 years ago and is the only disease-modifying treatment for allergic individuals (Allergy, 2012).

The American Academy of Allergy, Asthma & Immunology (AAAAI), a professional membership organization of more than 6,800 allergist/immunologists, is spreading the word that newly proposed regulations from the United States Pharmacopeia (USP) could dramatically limit patient access to allergen immunotherapy (allergy shots).

Help the AAAAI save patient access to allergy shots. Sign this petition to let USP know they should keep the existing requirements in place—and not move forward with these new proposed regulations:

https://www.change.org/p/united-states-pharmacopeia-save-patient-access-to-allergy-shots?recruiter=478779438

What are allergy shots and who is proposing these new regulations?

Allergy shots, also known as allergen immunotherapy, are an important treatment for allergic diseases that has substantially improved patient care, reduced emergency room visits, decreased medication costs and decreased hospitalization.

As mentioned above, the new regulations are being introduced by the United States Pharmacopeia (USP). There is no data in the peer-reviewed medical literature that allergy shots have ever caused infections in patients, but this is the concern driving USP to propose these new guidelines.



Treatment Options for 
Allergic Rhinitis (AR) and 
Non-Allergic Rhinitis (NAR) in 6 Steps (click to enlarge the image). En Español.

If these new regulations go into effect, how will it impact patients?

The more extensive procedures for mixing under the new regulations would make it highly unlikely that allergists would be able to continue to mix allergen extracts for their patients in the office setting.

Non-healthcare system employed physicians will have very limited options to secure allergy immunotherapy prescriptions for their patients. There are only two facilities that have been identified as resources for this service in the United States. Having to use outside facilities may limit the timelines of allergy shot treatment, among other consequences. Also Medicare currently does not cover allergen immunotherapy manufactured by a third party vendor. Thus, Medicare recipients, and potentially commercially insured patients, would no longer have allergen immunotherapy as a covered service. USP’s proposed requirements would directly transfer the cost of a previously covered benefit to the beneficiary.

What can I do to prevent these regulations from going into effect?

Again, sign this petition to let USP know: 1) you are concerned about how these proposed changes will impact patient access to allergen immunotherapy and 2) they should keep the existing requirements in place.

https://www.change.org/p/united-states-pharmacopeia-save-patient-access-to-allergy-shots?recruiter=478779438




Image source: Wikipedia, Creative Commons license.

FEF25-75 gets another look: Forced midexpiratory flow between 25% and 75% linked to asthma persistence

Forced midexpiratory flow between 25% and 75% of forced vital capacity (FEF25-75) is associated with long-term persistence of asthma and poor asthma outcomes.

Whether small-airway obstruction contributes to the long-term evolution of asthma remains unknown.

This French study assessed if forced midexpiratory flow between 25% and 75% of forced vital capacity (FEF25-75) was associated with the persistence of current asthma over 20 years and the subsequent risk for uncontrolled asthma independently of FEV1.

The study included 337 patients with asthma (asthma attacks or treatment in the past year, 142 children and 225 adults). The patients were followed up at the 12- and 20-year surveys.

Decreased FEF25-75 at the onset of the study increased the risk of:

- long-term asthma persistence, but only slightly (adjusted odds ratio (OR), 1.14)
- more severe bronchial hyperresponsiveness and current asthma a decade later (OR between 1.21 and 1.44)

Small-airway obstruction, as assessed based on FEF25-75, might contribute to the long-term persistence of asthma and subsequent risk for poor asthma outcomes, independently from FEV1.

References:

Forced midexpiratory flow between 25% and 75% of forced vital capacity is associated with long-term persistence of asthma and poor asthma outcomes. Siroux V et al. J Allergy Clin Immunol. 2015 Dec 11. pii: S0091-6749(15)01635-8. doi: 10.1016/j.jaci.2015.10.029. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/26688518

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

Image source: Spirometry, from Wikipedia, the free encyclopedia, GNU Free Documentation License.

Airway microbiome differs according to asthma severity

Bronchial brushings from 40 participants in the Bronchoscopic Exploratory Research Study of Biomarkers in Corticosteroid-refractory Asthma (BOBCAT) study were evaluated by using 16S ribosomal RNA–based methods. In patients with severe asthma, bronchial bacterial composition was associated with several disease-related features, including body mass index, Asthma Control Questionnaire (ACQ) scores, sputum leukocyte values, and bronchial biopsy eosinophil values.

Bacterial communities associated with worsening ACQ scores and sputum leukocyte values (predominantly Proteobacteria) differed markedly from those associated with body mass index (Bacteroidetes/Firmicutes). Expression of TH17-related genes was associated with Proteobacteria.

In contrast, improving/stable ACQ scores and bronchial epithelial gene expression of FK506 binding protein (FKBP5), an indicator of steroid responsiveness, correlated with Actinobacteria.

Patients with severe asthma compared with healthy control subjects or patients with mild-to-moderate asthma were significantly enriched in Actinobacteria, although the largest differences observed involved a Klebsiella genus member (7.8-fold increase in patients with severe asthma).

Specific microbiota may modulate inflammatory processes in patients with severe asthma and related phenotypes. Airway dysbiosis in severe asthma differs from milder asthma.

References:

The airway microbiome in patients with severe asthma: Associations with disease features and severity. Yvonne J. Huang et al. JACI, October 2015, Volume 136, Issue 4, Pages 874–884 (full text).
http://www.jacionline.org/article/S0091-6749(15)00838-6/fulltext

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

Small airways function in young children is linked to obstructive symptoms

Frequency dependence of resistance (R5-20) assessed by impulse oscillometry (IOS) is suggested to be a measure of small airways. Small airways involvement during induced bronchoconstriction has been shown to reflect severity of asthma in adults.

The researchers from Finland evaluated if methacholine (Mch) induced changes in R5-20 are associated with the severity of exercise induced bronchoconstriction (EIB) in 109 young children, aged 3-8 years (95 with obstructive symptoms, 14 healthy controls).

R5-20 was measured at baseline and after the Mch challenge. In a standardized exercise test, the children were grouped according to the severity of EIB expressed as the percentage increase in resistance at 5 Hz (ΔR5).

The baseline R5-20 was not associated with the severity of EIB. However, the change in R5-20 during Mch induced bronchoconstriction was significantly higher in children with severe EIB.

Frequency dependence of resistance (R5-20) measured by IOS during the Mch induced bronchoconstriction is associated with severe EIB in young children.

References:

Aberrant small airways function relates to asthma severity in young children. Kalliola S et al. Respir Med. 2015 Dec 19. pii: S0954-6111(15)30097-4. doi: 10.1016/j.rmed.2015.12.006. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/26733229

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

“Small airway-on-a-chip” enables in vitro research on human lung inflammation and drug responses

A human lung 'small airway-on-a-chip' was developed at Harvard University with sponsorship by Pfizer and Merck.

The chip contained a differentiated, mucociliary bronchiolar epithelium and an underlying microvascular endothelium that experiences fluid flow, which allows for analysis of organ-level lung pathophysiology in vitro. After the normal physiology was established in the chip, the researchers induced a pathology: exposure to interleukin-13 (IL-13) reconstituted the goblet cell hyperplasia, cytokine hypersecretion and decreased ciliary function of asthmatics.

Small airway chips lined with epithelial cells from individuals with chronic obstructive pulmonary disease (COPD) recapitulated features of the disease such as selective cytokine hypersecretion, increased neutrophil recruitment and clinical exacerbation by exposure to viral and bacterial infections.

With this in vitro method for modeling human lung inflammatory disorders, it would be feasible to:

- detect synergistic effects of lung endothelium and epithelium on cytokine secretion
- identify new biomarkers of disease exacerbation
- measure responses to anti-inflammatory compounds

References:
Small airway-on-a-chip enables analysis of human lung inflammation and drug responses in vitro. Benam KH et al. Nat Methods. 2015 Dec 21. doi: 10.1038/nmeth.3697. [Epub ahead of print]
http://www.nature.com/nmeth/journal/vaop/ncurrent/full/nmeth.3697.html

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php
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