A double-blind, placebo-controlled study of immunotherapy with grass-pollen extract Alutard SQ during a 3-year period with initial rush immunotherapy

Abstract

A double-blind, placebo-controlled study of immunotherapy with grass-pollen extract Alutard SQ during a 3-year period with initial rush immunotherapv Dolz I, Martinez-C6cera C, BartolomC JM, Cimarra M. A double-blind, placebo-controlled study of immunotherapy with grass-pollen extract Alutard SQ during a 3-year period with initial rush immunotherapy.Thirty patients with asthma and/or monosensitized allergic rhinitis caused by grass pollen whose ages ranged from 15 to 35 years were selected. Two groups were established at random: an active group and a placebo group, and a double-blind study was done on treatment with immunotherapy for a period of 3 continuous years, with initiation doses administered according to the rush immunotherapy technique. Grass-pollen allergen extract Alutard SQ and histamine as a placebo were used. The objective parameters of efficacy evaluated were end-point cutaneous tests, conjunctival provocation, bronchial provocation, and syniptom/medication scores, as well as specific immunoglobulin determinations. The statistical evaluation of the results was significant for the differences existing between the initial and final time of the active group, and there were significant differences between the two groups for all of the parameters considered. We found no relationship between clinical improvement and the range of specific immunoglobulin E values. Regarding the safety of the treatment, systemic adverse effects were manifested only in the initial phase (rush immunotherapy). and were easily controlled by treatment. We conclude that the efficacy and safety of immunotherapy with grass pollen make it possible to consider this treatment I fundamental in these patients.

Efficacy of subcutaneous and sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: A meta-analysis–based comparison

“…These data were available in all 36 trials for symptom score [9][10][11][12][13][14][15][16] and in 31 RCTs for medication score. [10][11][12][13]15,16,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][38][39][40][41][43][44][45][46][47] The outcome data analyzed were continuous, but different scoring systems and scales for symptoms and medication were used by the researchers. Therefore, to compare the results, analyses were performed by the method of standardized mean difference (SMD), expressing the differences in means between SLIT or SCIT and placebo in terms of units of the pooled SD.…”

“…The 36 RCTs 9-16,19-47 (22 for SLIT 9-14,20-35 and 14 for SCIT 15,16,[36][37][38][39][40][41][42][43][44][45][46][47] ) included a total of 3014 patients treated with immunotherapy and 2768 controls who received placebo. SLIT was administered by sublingual drops in 10 RCTs 10,12,[20][21][22][23][24][25][26][27] and by tablets in 12 RCTs.…”

Sublingual immunotherapy with once-daily grass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis

“…3 In patients who fail to respond to these measures, controlled trials have documented the efficacy of subcutaneously administered allergen-specific immunotherapy. [4][5][6][7] Clinical improvement has been shown to persist for at least 3 to 6 years after discontinuation of this treatment. [7][8][9] Thus, specific immunotherapy 10 is today the only treatment modality able to induce prolonged remission and prevent disease progression.…”

A Randomized Controlled Trial of Sublingual Immunotherapy for Japanese Cedar Pollinosis

“…Subcutaneous allergen-specific immunotherapy (SCIT) has been evaluated and shown to be an effective approach to change the course of allergic rhinitis [8,9,10,11,12,13], including Japanese cedar pollinosis [14]. However, an alternative method of administration is still required because the SCIT approach has been associated with the risk, albeit very low, of anaphylactic shock [15] and the inconvenience of frequent visits to the physician’s office.…”