Long-term efficacy of SQ grass AIT

The disease-modifying potential of SQ grass allergy immunotherapy, i.e., to induce long-term and sustained effects even after treatment cessation, was first demonstrated for SQ grass AIT administered as subcutaneous injections, in a small, randomised, controlled trial (known as ‘the Brompton study’). Since then, the disease-modifying effects of SQ grass AIT have been confirmed in two long-term, double-blinded, randomised, placebo-controlled trials. These long-term trials investigated the efficacy of SQ grass AIT when administered as a once-daily sublingual (SLIT) tablet in children and adults, respectively.

A once-daily treatment with SQ grass SLIT-tablets for 3 years in adults with grass pollen rhinoconjunctivitis resulted in significant reductions in both symptom and medication scores during the treatment period, and in disease modification, as demonstrated by a sustained effect after the completion of treatment (effect demonstrated after 1 and 2 year follow-ups).

Similarly, the long-term efficacy of SQ grass SLIT-tablet was demonstrated in children with a clinically relevant history of grass pollen-induced rhinoconjunctivitis and no medical history of asthma.

Please note analysis of the adult data from GT-08 is based on median values, where as the children data from the GAP study are adjusted means.

In both children and adults, a favourable safety profile has been demonstrated for the SQ grass SLIT-tablets. Patients taking SQ grass SLIT-tablets should primarily expect mild-to-moderate local allergic reactions to occur early in therapy, and that these tend to subside spontaneously within one-to-seven days. The most commonly reported adverse reactions are oral pruritus, throat irritation and oedema mouth. Overall, the adverse events profile in paediatric patients treated with SQ grass SLIT-tablet is similar to that observed in adults.

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The disease-modifying potential of SQ grass AIT was first demonstrated in the so-called ‘Brompton study’ in the early 90s.

The Brompton study design:

After 3-4 years of treatment with SQ grass AIT, which was administered as subcutaneous allergy immunotherapy (SCIT) injections (SQ grass SCIT), 32 subjects with a history of severe grass pollen allergy were randomised to two groups either maintaining or discontinuing their treatment and were subsequently followed for an additional 3 years together with a third, matched, control group, which had not been treated with AIT.

Scores for seasonal symptoms and the use of symptom-relieving medications were significantly lower in both SQ grass SCIT groups compared to the control group. For the treated patients randomised to discontinue SQ grass SCIT treatment, 3 years of sustained effects following treatment cessation were demonstrated. Importantly, similar sustained effects were observed in treated patients who continued, when compared to those who discontinued SQ grass SCIT treatment. Therefore, the trial suggests that 3-4 years of treatment with SQ grass SCIT can induce prolonged clinical remission in patients with severe grass pollen allergy.

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Durham et al. “SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial”, J Allery Clin Immunol. 2012; 129: 717-725. DOI: 10.1016/j.jaci.2011.12.973

Valovirta et al. “Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy”, J Allergy Clin Immunol. 2018; 141:529-538. DOI: 10.1016/j.jaci.2017.06.014

Durham et al. “Long-Term Clinical Efficacy of Grass-Pollen Immunotherapy” N Engl J Med. 1999; 341: 468-75. DOI: 10.1056/NEJM199908123410702