Sublingual immunotherapy with once-daily grass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis Stephen R. Durham,

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Presentation transcript:

Sublingual immunotherapy with once-daily grass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis Stephen R. Durham, MD, William H. Yang, MD, Martin R. Pedersen, MSc-Pharm, Niels Johansen, MSc-Chem Eng, Sabina Rak, MD Journal of Allergy and Clinical Immunology Volume 117, Issue 4, Pages 802-809 (April 2006) DOI: 10.1016/j.jaci.2005.12.1358 Copyright © 2006 American Academy of Allergy, Asthma and Immunology Terms and Conditions

Fig 1 Trial profile. Participants received double-blind trial medication once daily (placebo, 2500, 25,000, 75,000 SQ-T grass-pollen tablets) and single-blind Step 1 rescue medication as needed (loratadine or placebo; depicted as /active or /placebo). Sixty-five participants withdrew after randomization for the following reasons: adverse events (26), physician or sponsor decision (4), consent withdrawn (5), noncompliance (5), lack of or insufficient efficacy (4), protocol deviation (3), intake of excluded medication (2), lost to follow-up (9), and other (7). ITT, Intention-to-treat analysis set, defined as all randomized participants (n = 855); PP, per-protocol analysis set, defined as randomized participants who had completed the trial and taken sufficient trial medication (at least 80%) and provided sufficient diary data (at least 30% in 50% of the weeks; n = 748); Pre, preseasonal analysis set; participants with at least 8 weeks treatment before the grass pollen season (n = 640). Journal of Allergy and Clinical Immunology 2006 117, 802-809DOI: (10.1016/j.jaci.2005.12.1358) Copyright © 2006 American Academy of Allergy, Asthma and Immunology Terms and Conditions

Fig 2 Percentage reduction in the active treatment groups relative to the placebo group. The analyses for the entire (black bars) and peak (grey bars) pollen season included participants receiving active Step 1 medication. White bars show analysis for subjects receiving trial medication for at least 8 weeks before the grass pollen season; ∗data for 75,000 SQ-T are pooled data, entire pollen season (ie, participants receiving similar trial medication with active or placebo Step 1 rescue medication were pooled). A, Mean rhinoconjunctivitis symptom scores. B, Mean rhinoconjunctivitis medication scores. C, Induction of blocking antibodies. IgX is a measure of the level of inhibitory components to specific IgE–P pratense allergen binding and is a ratio of 2 IgE measurements. The figure shows the increase in inhibitory components relative to placebo. App., Approximately. Journal of Allergy and Clinical Immunology 2006 117, 802-809DOI: (10.1016/j.jaci.2005.12.1358) Copyright © 2006 American Academy of Allergy, Asthma and Immunology Terms and Conditions

Fig 3 Immunologic changes after treatment with placebo or grass pollen tablets 2500, 25,000, or 75,000 SQ-T. The amounts of specific (A) IgG and (B) IgE to Phleum pratense allergen are given in RU and kU/L, respectively. App, Approximately. Journal of Allergy and Clinical Immunology 2006 117, 802-809DOI: (10.1016/j.jaci.2005.12.1358) Copyright © 2006 American Academy of Allergy, Asthma and Immunology Terms and Conditions