Clinical Overview of Allergen Immunotherapy by malj

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									Rush and Cluster Immunotherapy

         Harold S. Nelson, MD
          Professor of Medicine
         National Jewish Health
  University of Colorado Health Science
                  Center
            Denver, Colorado
         Immunotherapy with a Standardized
       Dermatophagoides pteronyssinus Extract:
  III. Systemic reactions during the rush protocol in
            patients suffering from asthma.
      J Bousquet et al. J Allergy Clin Immunol 1989;83:797-802


 47/125 experienced systemic reactions:
 - Urticaria (4)
- Anaphylactic shock (8)
- Asthma exacerbations (35).
 Baseline FEV1 < 80% 73% systemic reactions.
Baseline FEV1 ≥ 80% 13% systemic reactions.
Difference all due to fewer asthma exacerbations.
         Immunotherapy with a Standardized
       Dermatophagoides pteronyssinus Extract:
        IV. Systemic reactions according to the
              immunotherapy schedule
         A Hajjaoui, et al. J Allergy Clin Immunol 1990;85:473-9


 To decrease systemic reactions serially introduced:
- Premedication: Oral CS, ketotiefen, Theophylline
(Group B)
- Premedication plus SIT givien only if FEV1 > 70%
and stopped for locals > 10 cm (Group C)
- Above plus RIT only four doses first day, then
single doses days 2, 5, 8, 11, & 14. (D)
 Systemic reactions according to the immunotherapy
                      schedule

                                                            Anaphyl
           Dose       SR’s       Urticaria     Asthma
                                                             axis

  RIT      2064       36%          12.7%         31%          5.1%

Pre-Med    1954       16%          3.8%          14%          1.8%

FEV1, lg
           1254       7.3%         0.6%           7%          0.2%
 locals

2-week     1662       5.4%         0.4%           5%          0.4%


            A Hajjaoui, et al. J Allergy Clin Immunol 1990;85:473-9
  Double-blind Comparative Study of
      Cluster and Conventional
    Immunotherapy Schedules with
   Dermatophagoides pteronyssinus.
     AI Tabar, et al. J Allergy Clin Immunol 2005;116:109-18

 239 patients with allergic rhinitis or asthma
  sensitive to house dust mites.
 Built up to a maintenance dose containing 3.2 g
  Der p 1 in an alum precipitated extract.
 Half by cluster with 15 shots in 6 weeks and half
  by 13 single weekly injections.
  Double-blind Comparative Study of
      Cluster and Conventional
    Immunotherapy Schedules with
   Dermatophagoides pteronyssinus.
Systemic reactions, all mild, occurred during the
 build-up stage in:

 Cluster: 3% of patients and 0.15% of injections.

 Weekly: 4% of patients and 0.31% of injections.



                  AI Tabar, et al. J Allergy Clin Immunol 2005;116:109-18
                              Decreased Prick Skin Tests

                    10
    Cut Tol Index




                                        *           *                                                     *
                                                                                                          *
                               *                     *
                                        *                                                     Cluster
                                                                                              Conventional

                     1
                         0    -    10                20            30          40                50           60
                         P0   P6    P12            P18         Weeks                                  P52

Cumlative Dose IT BU                                                        *Difference from P0; p<0.05
Cluster         25.3    25.3                41.3
Conventional         0.85           22.65          48.65
                                                           AI Tabar, et al. J Allergy Clin Immunol 2005;116:109
                                     Rhinitis Global Symptom-
                                         Medication Score
                                       1
Mean global score (standard error)

                                     0.9
                                     0.8                                                        Cluster

                                     0.7                                                        Conventional




                                                                     P=0.001
                                     0.6
                                     0.5
                                     0.4                                                    *             **
                                                                               *                          **
                                     0.3                                                    *
                                     0.2
                                     0.1
                                      0
                                                   T0                T1                   T1’         TF
                                           N       168               56                    55         143
                                               * Difference from T0 (wilcoxon, p<0.05)
                                               **Difference from T0 (wilcoxon, p<0.001)



                                                                 AI Tabar, et al. J Allergy Clin Immunol 2005;116:109
            Conclusions

 Build-up using alum-precipitated D.
pteronyssinus extract in a 6 week cluster
regimen was as well tolerated as a
conventional 12-week program of single
injections.
 Patients receiving cluster had more
rapid onset of immunologic response and
more rapid relief of symptoms.

               AI Tabar, et al. J Allergy Clin Immunol 2005;116:109
Experience at National
 Jewish with Cluster
Immunotherapy using
  Aqueous Extracts
         Cluster Immunotherapy
        Schedule: Injections B.I.W.
Visit          Vial            Dose
1              1:1000/1:100    0.1, 0.4 / 0.1
2              1:100/1:10      0.2, 0.4 / 0.07
3              1:10            0.1, 0.15, 0.25
4              1:10            0.35, 0.5
5              Full strength   0.07, 0.1
6              F.S.            0.15, 0.2
7              F.S.            0.3, 0.4
8              F.S.            0.5
   Cluster Immunotherapy: The
   National Jewish Experience
 3 dose-ranging studies, 2 with cat dander
extract and 1 with A-P dog extract.
 14 subjects received cluster to maintenance
dose of 15 g Fel d 1 and 7 to maintenance
dose of 15 g of Can d 1.
 1 mild systemic reaction (patient reached
projected maintenance with one extra
injection).
 Antihistamine pretreatment with cluster
immunotherapy: Premedication with loratadine
reduced the percent of patients with systemic
reactions from 79% to 33% (p = .002). Systemic
reactions were more severe in the placebo group.
Nielsen L, et al. JACI 1996;97:1207-13.
Administration of immunotherapy by a cluster
regimen:
- achieves both clinical and immunologic response
more rapidly
- does so with little or no increase in the risk of
systemic reactions.

								
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