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Published on: February 17, 2022
Ultra-short course immunotherapy in children and adolescents during a 3-yrs post-marketing surveillance study
Martin Rosewich1, Johannes Schulze, Karl J Fischer von Weikersthal-Drachenberg
1Pediatric Pulmonology & Allergology, Goethe University, Frankfurt/M, Germany. Martin.Rosewich@kgu.de
Insights
Ultra-short course immunotherapy (uSCIT) effectively treated children and adolescents with allergic conditions. This safe and well-tolerated treatment significantly reduced medication needs and showed comparable results to adults.
Area of Science:
- Allergy and Immunology
- Pediatric Pulmonology
- Pharmacovigilance
Background:
- Ultra-short course immunotherapy (uSCIT) demonstrates efficacy and tolerability in pediatric allergic diseases.
- Post-marketing surveillance (PMS) studies are crucial for evaluating real-world treatment outcomes.
- Understanding juvenile subpopulation responses to uSCIT is essential for optimizing pediatric allergy care.
Purpose of the Study:
- To evaluate the efficacy and tolerability of uSCIT in children and adolescents with seasonal allergic rhinitis (SAR), conjunctivitis, and/or asthma.
- To compare the efficacy of uSCIT in the juvenile subpopulation with the adult subpopulation within a PMS study.
- To assess the impact of uSCIT on anti-allergic medication consumption in young patients.
Main Methods:
- A prospective open study involving 422 patients aged 6-18 years with SAR, conjunctivitis, and/or asthma.
- Administration of four pre-seasonal injections of pollen allergoids with monophosphoryl lipid A (MPL, Pollinex Quattro) over at least 3 weeks.
- Evaluation of treatment response, anti-allergic medication use, and patient-reported tolerability, with comparisons to adult data.
Main Results:
- 94% of pediatric patients reported good or very good treatment response, consistent with the overall study cohort.
- Significant reduction in anti-allergic medication use from 83% to 24% after the first uSCIT course (p < 0.0001).
- High patient acceptance (93% 'very good' or 'good') and no serious adverse events or anaphylaxis reported in the juvenile group.
Conclusions:
- uSCIT with Pollinex Quattro exhibits comparable efficacy and tolerability in children/adolescents and adults with allergic conditions.
- The convenient dosing schedule and favorable safety profile of uSCIT support its broader adoption in pediatric populations.
- This PMS subanalysis confirms the value of uSCIT for managing pediatric allergic rhinitis, conjunctivitis, and asthma.
Abstract:
Ultra-short course immunotherapy (uSCIT) has shown good efficacy and tolerability in children and adolescents with seasonal allergic rhinitis (SAR), conjunctivitis and/or asthma in clinical studies. Here, we investigate the efficacy of uSCIT in the juvenile subpopulation of a 3-year post-marketing surveillance (PMS) study. To assess the differences in the efficacy of uSCIT between adults and children respectively adolescents enrolled in a PMS study. In a prospective open study 422 patients aged 6-18 years with SAR, conjunctivitis and/or asthma received four pre-seasonal injections with pollen allergoids formulated with monophosphoryl lipid A (MPL, Pollinex Quattro) over a minimum of 3 weeks. Efficacy was evaluated by response to therapy and consumption of anti-allergic medication during the pollen season. Tolerability was evaluated by patients' acceptance of therapy. These results were compared with the adult subpopulation of this study. Response to treatment was assessed as good or very good in 94% of patients, mirroring findings for the entire cohort. Further improvements were noted in patients receiving subsequent courses of therapy. Anti-allergic medication use decreased from 83% to 24% of patients after the first treatment course (p < 0.0001). Therapy was well accepted by children/adolescents and considered 'very good' or 'good' by 93% of juveniles. No serious adverse events or cases of anaphylaxis were reported. This subanalysis indicated that uSCIT with Pollinex Quattro had similar efficacy and tolerability in children/adolescents and adults. The convenient dosing regimen and favourable safety profile of uSCIT may support a wider uptake of uSCIT in this patient population.
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