Use of SLIT in allergy practice: Is it ready for prime time? Stanley Fineman, MD, MBA Atlanta Allergy & Asthma Clinic AAIFNC, Feb 7, 2015

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1 Use of SLIT in allergy practice: Is it ready for prime time? Stanley Fineman, MD, MBA Atlanta Allergy & Asthma Clinic AAIFNC, Feb 7, 2015

2 Disclosures Speakers bureau/consultant: AZ, Genentech/Novartis, Meda, Merck, Mylan, Nestle, Teva Clinical research: Genentech, Meda, Teva

3 Learning objectives: Discuss historical use of SLIT. Understand logistics of offering SLIT in allergy practice. Evaluate risks and benefits of offering SLIT in allergy practice.

4 Outline Why offer SLIT? How do we mix? How do we charge? Pros & Cons Should you offer this to your patients?

5 Why offer SLIT

6 Dr Cox: AAAAI 2006

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11 Dr Cox: AAAAI 2006

12 JACI 2011;127:S1-S55

13 JACI 2011;127:S1-S55

14 Clinical trials, irrespective of their design, of SLIT in the treatment of respiratory and food allergy in patients 18 years or younger were selected (29 of 56 articles). Quality of each trial and total quality of compounded evidence was analyzed with the Grading of Recommendations Assessment, Development and Evaluation system. Annals Allergy Asthma Immunol 2013;110:

15 What did they report? Of 56 articles, 29 met the inclusion criteria. Evidence is robust for the pre-coseasonal tablet and drop grass pollen SLIT efficacy in allergic rhinitis and for seasonal allergic asthma For house dust mite (HDM) SLIT in asthma, there is highquality evidence for medication reduction while maintaining symptom control Evidence for HDM SLIT efficacy in allergic rhinitis is of moderate-low quality. There is moderate evidence for efficacy of dual grass pollen and HDM SLIT after 12 months of treatment and 1 year after discontinuation in AR No anaphylaxis was found among 2469 treated children Some evidence for Alternaria SLIT efficacy is appearing Annals Allergy Asthma Immunol 2013;110:

16 March 2013

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21 JACI Pract 2014;2:144-9

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23 What is the trend now?

24 Specialty Distribution by Type of Immunotherapy Provided Annals Allergy 2014;112: Subcutaneous N=199; Sublingual N=62. These Ns represent those providers who provide IT (IT17a) and who did not indicate that they had no patients on subcutaneous (IT18a) or sublingual (IT19a) IT. Ns by specialty are shown in parentheses with subcutaneous first. 24

25 Annals Allergy 2013;110:

26 Annals Allergy 2013;110:

27 Are pts more likely to use SLIT?

28 Children s compliance with allergen immunotherapy according to administration routes. Panjo, et al; Letter JACI JACI 2005;116:

29 Children s compliance with allergen immunotherapy according to administration routes. Panjo, et al; Letter JACI JACI 2005;116:

30 More Italian experience JACI 2010; 126:668-9

31 Persistence with Specific Immunotherapy (SCIT & SLIT) Among AR Patients in A US Allergy Practice Anolik et al AAAAI San Antonio 2013 Methods: Data from a retrospective chart review study of allergic rhinitis patients managed at a group allergy practice in the US initiating subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) from were analyzed.

32 Persistence with SCIT & SLIT with AR pts Anolik et al: Results A total of 3,182 patients were identified, 78% chose SCIT and 22% chose SLIT Only 32.5% of patients completed treatment; 35% of SCIT and 23.7% of SLIT patients Median time on therapy was longer for SCIT patients (3.6 years) versus SLIT patients (2.6 years) Similar patterns were seen among children AAAAI 2013

33 Review of previous studies: 55%-82% of pts abandon SLIT before completing recommended course (3-5 year) Recommend: Communication improvement Educational tools F/U visits Telecommunication techniques JACIinPract 2014;2:

34 JACIinPract 2014;2:

35 JACIinPract 2014;2:

36 How do we mix?

37 Logistics Glass dropper bottles w/ metered dose pump Delivers 0.05 ml per drop (50 mcl) Bottles have 15 ml capacity Fill to 8 ml Sterile 50% glycerine used as diluent Maintenance dose if 0.25 ml (5 drops) per day Each 8 ml maintenance bottle lasts a month

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40 Logistics, continued Start with two build-up vials and one maintenance vial Build-up vials are 10-fold serial dilutions of the maintenance concentration (ie 1:10 w/v & 1:100 w/v) Dose in the mornings Hold drops under tongue for 2-3 minutes Patient may swallow or spit after 2 minutes Do not eat or drink for 5-10 minutes after dosing

41 Treatment Schedule Maintenance vials: 5 drops/ day Adjust dose if more than 4 doses are missed

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43 Costs of Extracts at AAAC Extract Cost/50 ml Amount in vial Cost in Vial HDM mix, 10,000 AU $143 1 ml $2.86 Cat 10, 000 BAU $ ml $5.46 Birch 1:20 w/v $ ml $2.33 Oak 1:20 w/v $93 1 ml $1.86 Mixed Ragweed 1:20 $ ml $2.79 Bermuda, 10,000 BAU $ ml $1.20 Timothy 100,000 BAU $ $1.20 Diluent 50% glycerin $2 Max total cost $18.00

44 How many pts have ordered SLIT? April 2013 Dec 2013 Jan 2014 Dec pts 86 pts

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46 Pros & Cons of SLIT Safety Fewer systemic reactions than SCIT Some local/oral reactions Efficacy Many studies showing efficacy Some question about multiple allergen efficacy Convenience Not an injection Administered at home

47 Pros & Cons of SLIT Not FDA-approved for drops No clear-cut established protocol Costs for patient all out of pocket for drops Tablets covered as a pharmacy benefit Pts need to be trained to recognize and treat anaphylaxis Epinephrine autoinjector for all patients

48 Outline Why offer SLIT? How do we mix? How do we charge? Pros & Cons Should you offer this to your patients?

49 Which way is best for you?