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The allergen extract database: assessments Ronald L. Rabin, MD Chief, Laboratory of Immunobiochemistry Division of Bacterial, Parasitic and Allergenic.

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Presentation on theme: "The allergen extract database: assessments Ronald L. Rabin, MD Chief, Laboratory of Immunobiochemistry Division of Bacterial, Parasitic and Allergenic."— Presentation transcript:

1 The allergen extract database: assessments Ronald L. Rabin, MD Chief, Laboratory of Immunobiochemistry Division of Bacterial, Parasitic and Allergenic Products Office of Vaccines Research and Review Center for Biologics Evaluation and Research, USFDA

2 2 Today’s presentations Background Allergenics efficacy reviews –Panel 1, 21 CFR ( ) –Panel 2, 21 CFR ( ) Current evaluation process ( ) Safety of allergenic extracts Assessments Next steps

3 3 Safety and efficacy of non-standarized allergen extracts Panel 1 reviewed 773 extracts –Category I: 335 –Category II: 1 –Category IIIA: 431 –Category IIIB: 6 Panel 2 reviewed 752 extracts –Category I: 723 –Category II: 29 Current review: 1269 extracts Safety review and literature demonstrates that safety concerns are associated with the procedure of immunotherapy rather than any one product or set of products

4 4 Format of database Product Manufacturers of this Product Search Strategy Nomenclature Parent Product Related Product Published Data Reference Document List Original and Reclassification Panel recommendations

5 5 Format of database: Product Database entry number Product Category Product Name as listed in FDA files

6 6 Format of database: Manufacturers of this Product Manufacturers of this Product Antigen Laboratories, Inc. - Liberty, MO (Lic. No. 468, STN No ) Greer Laboratories, Inc. - Lenoir, NC (Lic. No. 308, STN No ) Hollister-Stier Labs, LLC - Spokane, WA (Lic. No. 1272, STN No ) ALK-Abello Inc. - Port Washington, NY (Lic. No. 1256, STN No ) Allermed Laboratories, Inc. - San Diego, CA (Lic. No. 467, STN No ) Nelco Laboratories, Inc. - Deer Park, NY (Lic. No. 459, STN No ) Allergy Laboratories, Inc. - Oklahoma City, OK (Lic. No. 103, STN No ) All manufacturers distribute the extract of this species under the same name; not always the case.

7 7 Format of database: Search Strategy Search Strategy PubMed: "alternaria alternata"; "alternaria tenuis"; "alternaria alternata" allergen; "alternaria tenuis" allergen; "alternaria alternata" immunotherapy Google: alternaria tenuis allergy; alternaria tenuis allergy adverse; alternaria tenuis allergen; alternaria tenuis allergen adverse Note that searches included scientific/medical and lay sources

8 8 Database field: Nomenclature Nomenclature ATCC website: Alternaria alternata (Fries) Keissler, anamorph deposited as Alternaria tenuis Nees, anamorph. Stedmans Book (ATCC Fungus Names, 1993): Alternaria alternata (Fries) Keissler (1912);Synonomy: Alternaria tenuis, Nees 1816; Alternaria tomato (Cooke) Brinkman 1931; Alternaria dioscoreae, Vasant Rao, 1961; Torula alternata Fries Index Fungorum website: Alternaria alternata (Fr.) Keissl., Beih. bot. Zbl., Abt. 2 29: 434 (1912); Synonymy:Torula alternata Fr., Syst. mycol. (Lundae) 3(2): 500 (1832); Ulocladium consortiale sensu Brook; fide NZfungi (2008); Alternaria tenuis Nees, Syst. Pilze (Würzburg): 72 (1816); Macrosporium asciculatum Cooke & Ellis, Grevillea 6(no. 37): 6 (1877); Alternaria fasciculata (Cooke & Ellis) L.R. Jones & Grout, Bull. Torrey bot. Club 24(5): 257 (1897); Alternaria rugosa McAlpine, Agric. Gaz. N.S.W., Sydney 7:304(1896). Sources: ITIS: Integrated Taxonomic Information System; ATCC: American Type Culture Collection;

9 9 ITIS Database

10 10 ITIS search on “ragweed”

11 11 ITIS—“short ragweed” 11

12 12 ITIS—“short ragweed”

13 13 ITIS—“short ragweed” 13

14 14 Format of database: Recommended Names Recommended Scientific Name Alternaria alternata Recommendations based on Nomenclature review Harmonizes nomenclature among products derived from the same species Minimizes prescription errors

15 15 Database field: Parent Product Parent Product Molds, Rusts and Smuts, Alternaria tenuis (alternata) Aligns all products (“Parent” with “Related”) derived from the same species into a subset of identical extracts For alternaria alternata, there are no “related products.”

16 16 Database field: Related Product (Mugwort) Parent Product Pollens - Weeds and Garden Plants, Sage, Mugwort, Western Artemisia ludoviciana Related Products Pollens - Weeds and Garden Plants, Mugwort, Darkleaved Artemisia ludoviciana Pollens - Weeds and Garden Plants, Mugwort, Western Artemisia ludoviciana Pollens - Weeds and Garden Plants, Sage, Mixed Artemisia ludoviciana Pollens - Weeds and Garden Plants, Sage, Prairie, Artemisia gnaphaloides Pollens - Weeds and Garden Plants, Sage, Western Artemisia gnapholodes Pollens - Weeds and Garden Plants, Sagebrush, Prairie Artemisia gnaphalodes Pollens - Weeds and Garden Plants, Sagebrush, Prairie Artemisia ludoviciana Pollens - Weeds and Garden Plants, Sagebrush, Western Artemisia graphaloides Pollens - Weeds and Garden Plants, Sagebrush, White (Prairie) Artemisia ludoviciana This is an example of products that are “Related” to a “Parent” product

17 17 Database field: Published Data Published Data A. alternata (and Cladosporium) sensitivity correlates with asthma severity in Europe. A. alternata was used for diagnosis in several papers, PMID , , , , , , Several trials demonstrate that immunotherapy works in rhinitis, PMID , , , , , , Note severe reactions reported in PMID Publications usually listed by PubMed ID (PMID) for ease of search and download Brief summary of the report(s) 17

18 18 Format of database: Documents Document: Abbreviated citation PubMed identification number (PMID) First Author Year of publication

19 19 Internal review determinations (1269 products reviewed) Table 1.Use in Diagnosis and Treatment Addressed in Literature (480) Table 2. Foods: Use in Diagnosis Addressed in Literature (134) Table 3. Non-food: Use in Diagnosis Addressed in Literature (73) Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566) Table 5. Potential Safety Issues (16)

20 20 Table 1. Use in Diagnosis and Treatment Addressed in Literature Product: Pollens - Trees, Box Elder Acer negundo Manufacturers of this Product Antigen Laboratories, Inc. - Liberty, MO (Lic. No. 468, STN No ) Greer Laboratories, Inc. - Lenoir, NC (Lic. No. 308, STN No ) Hollister-Stier Labs, LLC - Spokane, WA (Lic. No. 1272, STN No ) ALK-Abello Inc. - Port Washington, NY (Lic. No. 1256, STN No ) Allermed Laboratories, Inc. - San Diego, CA (Lic. No. 467, STN No ) Nelco Laboratories, Inc. - Deer Park, NY (Lic. No. 459, STN No ) Allergy Laboratories, Inc. - Oklahoma City, OK (Lic. No. 103, STN No )

21 21 Table 1. Use in Diagnosis and Treatment Addressed in Literature Search Strategy PubMed: Acer negundo allergens; Boxelder allergens Google: box elder allergy; box elder allergy adverse; box elder allergen; box elder allergen adverse; same search results performed for Acer negundo

22 22 Table 1. Use in Diagnosis and Treatment Addressed in Literature Nomenclature According to ITIS, the scientific name, Acer negundo, is correct and current. Common names are ashleaf maple, box elder, boxelder maple, California boxelder,... The Acer genus is found in the Aceraceae family. PLANTS database states that Acer negundo is in the Aceraceae Family or Maple Family and lists five varieties of A. negundo that have the common name,...

23 23 Table 1. Use in Diagnosis and Treatment Addressed in Literature Published Data Panel 1 (pg 3157) cites two case studies of skin test diagnosis for maple pollen extracts (Ref. 153 and 154) but did not specify their genus or species. PMID describes how patterns of cross-sensitivity to tree pollens were identified... The following tree pollens were examined by modified radioallergosorbent test (RAST): oak, birch, beech, poplar (populus deltoides),.. The highest prevalence of hypersensitivity was for (birch, oak, and maple)... PMID reports on the use of polymerized ragweed (PRW), polymerized grasses (IPG) and polymerized trees (IPT) for immunotherapy in ragweed patients... All patients had (+ SPT to one or) more of the following 1:10 tree extracts: white oak, elm, or box elder... The patient's immunotherapy was administered in 12 weekly visits during the spring and summer of Of the 16 recruited patients, 10 were prick positive to box elder, 13 to elm, and 14 to oak... In terms of Safety,.. there were no systemic reactions in this group of patients...

24 24 Format of database: Previous Panel Category Determinations Original Panel Recommendation Reclassification Panel Recommendation Diagnosis:Category I Therapy:Category IIIACategory I

25 25 Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment Product: Plants and Plant Parts, Jute Corchorus sp. PubMed: jute; jute allergy; jute allergen; jute immunotherapy; jute corchorus Google: jute corchorus allergy; jute corchorus allergy adverse; jute corchorus allergen; jute corchorus allergen adverse Recommended Scientific Name Corchorus, (species to be specified) Manufacturers of this Product (Refer to published database)

26 26 Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment Search Strategy PubMed: jute; jute allergy; jute allergen; jute immunotherapy; jute corchorus Google: jute corchorus allergy; jute corchorus allergy adverse; jute corchorus allergen; jute corchorus allergen Nomenclature According to the USDA PLANTS database, there are 9 species of Corchorus. According to ITIS, there is one variety and eight species of Corchorus. The Corchorus genus is found in the Tiliaceae family. Parent Product Plants and Plant Parts, Jute Corchorus sp. Published Data No supportive data were identified.

27 27 Table 4. - Non-Standardized Allergenic Extracts: Minimal or No Literature Relating to Use in Diagnosis and Treatment Original Panel Recommendation Reclassification Panel Recommendation Diagnosis:Category IIIACategory II Therapy:Category IIIACategory II

28 28 Internal review determinations (1269 products reviewed) Table 1.Use in Diagnosis and Treatment Addressed in Literature (480) Table 2. Foods: Use in Diagnosis Addressed in Literature (134) Table 3. Non-food: Use in Diagnosis Addressed in Literature (73) Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566) Table 5. Potential Safety Issues (16)

29 29 Internal review compared to Panel 1 and 2 Internal evaluations of Panel 2 products Panel 2 category Panel 1 category Internal evaluations of Panel 1 products Diagnosis and treatment addressed in the literature (Percent)

30 30 Summary The current internal panel reviewed 1269 non-standardized allergenic products. Each was placed into one of five categories: Table 1.Use in Diagnosis and Treatment Addressed in Literature (480) Table 2. Foods: Use in Diagnosis Addressed in Literature (134) Table 3. Non-food: Use in Diagnosis Addressed in Literature (73) Table 4. Minimal or No Literature Relating to Use in Diagnosis and Treatment (566) Table 5. Potential Safety Issues (16)

31 31 Today’s presentations Background Allergenics efficacy reviews –Panel 1, 21 CFR ( ) –Panel 2, 21 CFR ( ) Current evaluation process ( ) Safety of allergenic extracts Assessments Next steps


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