allergen immunotherapy: from shots to tablets

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Allergen Immunotherapy: From Shots to Tablets. Susan Waserman MSc MDCM FRCPC Professor of Medicine Division of Clinical Allergy and Immunology Life and Breath May 1, 2014. Presenter Disclosure. To: Understand the treatment of allergic rhinitis (AR) - PowerPoint PPT Presentation

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  • Allergen Immunotherapy: From Shots to TabletsSusan Waserman MSc MDCM FRCPCProfessor of MedicineDivision of Clinical Allergy and ImmunologyLife and BreathMay 1, 2014

  • Presenter Disclosure

    Presenter:Dr Susan WasermanRelationships with commercial interests:Grants/research support:N/ASpeakers bureau/honoraria:GSK, Merck, Baxter Biologics, CSL Behring, King Pharma, Pfizer Canada, Sanofi Aventis, Nycomed Canada, ShireConsulting fees:GSK, Merck, Baxter biologics, CSL Behring, King Pharma, Pfizer Canada, Sanofi Aventis, Nycomed Canada, Shire

    Other:Scientific Advisory Committee on Respiratory and Allergy Therapies (Health Canada)Faculty McMaster University

  • Learning ObjectivesTo:Understand the treatment of allergic rhinitis (AR)Discuss immunotherapy (IT) in the treatment of ARTo introduce a new form of IT, sublingual tablets, also know as SLIT-T

  • Allergic Rhinitis Seasonal Allergic Rhinitis (SAR)Tree, grass and ragweed pollens Present from spring through fall Perennial Allergic Rhinitis (PAR)Dust mites, cockroaches, molds and animal dander Chronic condition

  • Simplified AR Treatment AlgorithmSmall and Kim. AACI Nov 2011.Treatments can be used individually or in any combinationAllergen avoidanceAllergen immunotherapy (SCIT/SLIT)Oral antihistaminesLeukotriene receptor antagonistsIntranasal corticosteroids

  • Nasal steroids

  • *Nasal salines

  • **

  • Why do Allergists Love IT?

    Subcutaneous immunotherapy (SCIT) has been used for over 100 yearsWell documented efficacy for AR and asthma secondary to pollens, HDM, and cat What are the benefits of SCIT?Relieves symptomsHas disease-modifying effectsMay prevent new sensitization and asthma

  • Reality of SCIT

    Only 2% to 9% of US patients, and 4% of Canadians with AR receive SCIT, and many stop it prematurely because of frequent office visits and the 30 minute wait time after injections1,2Systemic allergic reactions occur in about 5%Small risk of death (1/2.5 million injections) but recent 3 year survey of 25 million showed no fatalities

    1. Hankin CS. J Allergy Clin Immunol. 2013;131:1084-91.2. Hsu NM, Reisacher WR. Int Forum Allergy Rhinol. 2012;2:280-43. Bernstein DI et al. J Allergy Clin Immunol 2004;113:1129-36

  • Do We Need a New Immunotherapy?Yes!

    Enter sublingual immunotherapy tablets (SLIT-T)In Canada, there are now 2 new treatments (SLIT-T) for treatment of grass pollen AROralair (age >6 yrs)-launched Nov/2012Grastek (age >5 yrs)-launched Feb/2014Home based therapy, effective in first seasonGiven at least 8 weeks before grass pollen season and during season, usually 6 months

  • Grass SLITGrastek (ALK-Merck)contains Timothy grass pollen 2800 BAU (Bioequivalent Allergy Units)Oralair (Stallergenes-Paladin)contains 5 grass pollens (Timothy, Sweet Vernal, Orchard, Perennial Rye, and Kentucky Blue Grass)300 IR (Index of Reactivity)

  • Grass SLIT-T

  • Indications and Clinical UseGRASTEK is indicated for reducing the signs and symptoms of moderate to severe seasonal grass pollen induced allergic rhinitis (with or without conjunctivitis) in adults and children 5 years of age and older confirmed by clinically relevant symptoms for at least two pollen seasons and a positive skin prick test and/or a positive grass specific IgE titre, and who have responded inadequately, or are intolerant to conventional pharmacotherapy

    Grastek Product Monograph. Dec 12, 2013

  • Disease Modification Has Been Shown After 3 Years of Treatment in a Randomized Trial of Grass SLIT-T Stephen R. Durham, MD, Waltraud Emminger, MD, Alexander Kapp, MD, PhD, Jan G. R. de Monchy, MD, Sabina Rak, MD, Glenis K. Scadding, MD, FRCP, Peter A. Wurtzen, PhD, Jens S. Andersen, PhD, Bente Tholstrup, MSc, Bente Riis, PhD, and Ronald Dahl, MD

    J Allergy Clin Immunol 2012;129:717-25

  • Combined Symptom and Medication Score For The Five Grass Pollen SeasonsDurham et al., J Allergy Clin Immunol 2012;129:717-25

  • Adverse Reactions Product Monograph ADR Adults /Pediatricsoral pruritus (26.7% vs. 3.5% placebo)throat irritation (22.6% vs. 2.8%)ear pruritus (12.5% vs. 1.1%)mouth edema (11.1% vs. 0.8%)most local allergic events were mild and transient with no progression to anaphylaxisrecurrent symptoms generally resolved over timemore common in the rst month of treatment

  • Prevention of Asthma with SLIT216 sensitized children without asthma randomized to treatment with:medication alone ormedication + SLIT for 3 yearsIT with HDM (98), grass (41), birch (4), parietaria (1)Outcomes after 3 years:clinical symptomsmethacholine reactivityskin prick testingMarogna M et al. Ann Allergy, Asthma, Immunol 2008:101:206-11

  • Clinical Outcomes After 3 Years of SLITMarogna M et al. Ann Allergy, Asthma, Immunol 2008:101:206-11p
  • Comparison of Medications and IT in the Treatment of SAR Meta-analysesIntervention

    Anti H1INSLTRASCITSLIT% Improvement Over Placebo7-917-16530-4030-40

  • When to Refer AR to an AllergistPatients AR symptoms are not controlled on medicationPatient is having side effects to or does not want to take medicationTo identify allergic triggers for proper allergen avoidanceFor consideration of IT

  • First Dose of SLIT-TUnder MD supervision, 30 minutes of observation, appropriate equipmentGrastek:No build up-start at 2800 BAUOralair :Build up-100 IR Day 1200 IR Day 2300 IR dailyPatients should be counseled about local side effects

  • Dose AdministrationTablet should be placed under the tongue, where it dissolvesInstruct the patient not to swallow for 1 minute, and to avoid eating and drinking for 10 minutes Should be administered daily at approximately the same time each day

  • ConclusionsIn patients with grass pollen allergy who have not responded to or are intolerant to medication:SLIT-T is a new, effective treatment optiondemonstrated safetysuitable for pediatric useadministered at homeRagwiteck tablets for ragweed is coming!!

    This slide must be visually presented to the audience AND verbalized by the speaker.

    *This slide lists the Learning Objectives that were taken into account in the development of this program.Seasonal allergic rhinitis (SAR) occurs mainly during pollen seasons, often involving reactions to tree, grass and ragweed pollens. Perennial allergic rhinitis (PAR) occurs year-round and often involves reactions to house dust mites, cockroaches, molds and animal dander.Grass typically is at highest levels in mid summer in most of Canada.SAR and PAR often co-exist, and many people with PAR have seasonal triggers/flares.This slide presents a simplified algorithm for AR treatment, highlighting a central role of intranasal corticosteroids since these are the mainstay of therapy for a majority of patients who present to physicians with AR. The algorithm depicts that these treatments can be used individually or in any combination with each other.

    Reference:Small P, Kim H. AACI, November 2011.

    *Immunotherapy has been used in medicine for about a century, while the mechanisms of this therapy have become better defined. Subcutaneous immunotherapy is now known to be effective in AR, asthma and atopic dermatitis, and to have disease-modifying benefits. However, it is also associated with major time commitment and with a significant risk of anaphylaxis. *Fatalities occur at a rate of 1 per 2.5 million injections (3.4/yr in the US/Canada)Vast majority occur in asthmaticsFatalities associated with:Poorly controlled asthmaDelayed administration of epinephrine / resuscitation effortsSCIT must be administered in a setting where prompt recognition and treatment of anaphylaxis is assuredEpi 0.3-0.5 cc 1:1000 IMPatients must remain in the physicians office at least 20 mins (AR) - 30 mins (asthmatics) after an injection

    AIT ACM 2013**The sublingual immunotherapy tablet (SLIT-T) represents a novel treatment choice in Canada for AR, available for the treatment of grass allergy.As will be discussed, SLIT-T has been shown to be effective in children and adults, and to have disease-modifying effects. This therapy can be taken by patients at home (following the first dose in the clinic with an observation period), and associated with minimal risk of anaphylaxis. *The two grass SLIT-T products being made available in Canada are listed here.*****The trial was initially planned to cover a single grass pollen season, and when the trial was extended to another 4 years, 195 participants chose not to enroll or were not offered enrolment because of closure of sites. The participants in the extension were a representative subset of the population originally included in the trial (see Dahl et al12).Numbers of participants in the analyses, that is, all participants providing diary data during the grass pollen season without imputation of data.All mean values refer to adjusted means. Adjusted; avg., averaged.*Referral of patients with AR to an allergist may be warranted when symptoms are not completely responding to medical therapy, when the patient or referring physician would like to identify specific allergic triggers (and the patient can avoid identified triggers), and/or when immunotherapy is being considered.

    *Several steps can help to ensure that the initiation of SLIT-T goes smoothly and is well tolerated by patients. Preparing patients by explaining to them the symptoms they might experience is an important part of this process. This will make patients less anxious in advance of the initial dose, and less apprehensive about symptoms they experience during the initial and subsequent doses.Expected reactions should be reviewed again during follow-up phone calls, and if possible the timing of these calls should occur around the timing of the dosing.

    *Regarding

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