Negative Clinical Results from a Randomised, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy of Two Doses of Immunologically Enhanced, Grass Subcutaneous Immunotherapy Despite Dose-Dependent Immunological Response

Kleine-Tebbe, J.; Walmar, Mikkel; Bitsch-Jensen, Klaus; Decot, Elke; Pfaar, Oliver; Hernández, Dolores; Rodríguez, F.

doi:10.1007/s40261-014-0216-z

Cited by 13 publications

(10 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Many conventional SCIT extracts and dosage regimens have failed to show significant improvement after the first year of treatment. 19 20 The rapid onset of 1 course of MPL-SCIT against grass is fascinating and in keeping with a recent study of allergic rhinitis. 21 The authors of that study evaluated the clinical efficacy and safety of ragweed MPL compared to a placebo using controlled ragweed pollen exposure.…”

Section: Discussionmentioning

confidence: 57%

Induction of Bronchial Tolerance After 1 Cycle of Monophosphoryl-A-Adjuvanted Specific Immunotherapy in Children With Grass Pollen Allergies

Rosewich

Girod

Zielen

et al. 2016

Allergy Asthma Immunol Res

View full text Add to dashboard Cite

PurposeSubcutaneous allergen-specific immunotherapy (SCIT) is a well-established and clinically effective method to treat allergic diseases, such as rhinitis and asthma. It remains unclear how soon after initiation of an ultra-short course of grass pollen immunotherapy adjuvanted with monophosphoryl lipid A (MPL)-specific bronchial tolerance can be induced.MethodsIn a prospective study of 69 children double-sensitized to birch and grass pollens (51 males, average age 11.1 years), development of bronchial tolerance after 1 cycle of SCIT for grass was evaluated. In all the patients, the bronchial allergen provocation test (BAP) was performed before and after treatment. According to the results of the first BAP, the patients were divided into 2 groups: those showing a negative BAP with a decrease in FEV1 of <20% (seasonal allergic rhinitis [SAR] group, n=47); and those showing a positive BAP with a decrease in FEV1 of ≥20% (SAR with allergic asthma [SAR and Asthma] group, n=22). All the patients received MPL-adjuvanted, ultra-short course immunotherapy for birch, but only those with a positive BAP to grass received MPL-SCIT for grass.ResultsAfter the pollen season, the BAP in the SAR group remained unchanged, while it was improved in the SAR and Asthma group (decrease in FEV1 of 28.8% vs 12.5%, P<0.01). The IgG4 levels increased after SCIT (median before SCIT 0.34 to 11.4 after SCIT), whereas the total and specific IgE levels remained unchanged.ConclusionsAfter 1 cycle of MPL-SCIT, specific bronchial tolerance may be significantly induced, whereas in patients without SCIT, bronchial hyperactivity may remain unchanged.

show abstract

Section: Discussionmentioning

confidence: 57%

Induction of Bronchial Tolerance After 1 Cycle of Monophosphoryl-A-Adjuvanted Specific Immunotherapy in Children With Grass Pollen Allergies

Rosewich

Girod

Zielen

et al. 2016

Allergy Asthma Immunol Res

View full text Add to dashboard Cite

show abstract

“…This resulted in a shift of the sIgE:sIgG 4 ratio towards the induction of tolerance. These data, especially the induction of sIgG 4 , concur with those of previous studies investigating conventional and short‐course adjuvant‐containing SCIT and sublingual immunotherapy . The desirable immunological effects, which are similar to those of conventional long‐term SCIT treatment, elucidate the mechanisms of action of LPP.…”

Section: Discussionmentioning

confidence: 99%

Lolium perenne peptide immunotherapy is well tolerated and elicits a protective B‐cell response in seasonal allergic rhinitis patients

Mösges

Koch

Raskopf

et al. 2018

Allergy

View full text Add to dashboard Cite

BackgroundSystemic allergic reactions are a risk for allergen immunotherapy that utilizes intact allergen preparations. We evaluated the safety, efficacy and immune mechanisms of short‐course treatment with adjuvant‐free Lolium perenne peptides (LPP) following a 6‐week dose‐escalation protocol.MethodsIn a prospective, dose‐escalation study, 61 grass pollen–allergic patients received 2 subcutaneous injections of LPP once weekly for 6 weeks. Safety was assessed evaluating local reactions, systemic reactions and adverse events. The clinical effect of LPP was determined by reactivity to the conjunctival provocation test (CPT). Specific IgE, IgG4 and blocking antibodies were measured at baseline (V1), during (V6) and after treatment (V8).ResultsNo fatality, serious adverse event or epinephrine use was reported. Mean wheal diameters after injections were <0.6 cm and mean redness diameters <2.5 cm, independent of dose. Transient and mostly mild adverse events were reported in 33 patients. Two patients experienced a grade I and 4 patients a grade II reaction (AWMF classification). At V8, 69.8% of patients became nonreactive to CPT. sIgG4 levels were higher at V6 (8.1‐fold, P < .001) and V8 (12.2‐fold, P < .001) than at V1. The sIgE:sIgG4 ratio decreased at V6 (−54.6%, P < .001) and V8 (−71.6%, P < .001) compared to V1. The absolute decrease in IgE‐facilitated allergen binding was 18% (P < .001) at V6 and 25% (P < .001) at V8.ConclusionIncreasing doses of subcutaneous LPP appeared safe, substantially diminished reactivity to CPT and induced blocking antibodies as early as 4 weeks after treatment initiation. The benefit/risk balance of LPP immunotherapy remains to be further evaluated in large studies.

show abstract

“…However, unfavorable results were also reported. Kleine‐Tebbe et al did a double‐blind random clinical trial of SIT in 450 cases with allergic disorders and found no statistically significant differences in results between the active groups and the placebo group. Our studies found that although clinical symptoms of perennial allergic rhinitis were suppressed after treatment with a 6‐month SIT, symptoms relapsed 1 month after termination .…”

Section: Discussionmentioning

confidence: 99%

Long‐term effects: Galectin‐1 and specific immunotherapy for allergic responses in the intestine

Yang

Shu

Luo

et al. 2017

Allergy

View full text Add to dashboard Cite

show abstract

Negative Clinical Results from a Randomised, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy of Two Doses of Immunologically Enhanced, Grass Subcutaneous Immunotherapy Despite Dose-Dependent Immunological Response

Abstract: The inconclusive results were most probably influenced by a very low grass pollen season. Other factors such as the extent of the pre-seasonal treatment could potentially have contributed. The tolerability profile was acceptable for further development.

Cited by 13 publications

References 17 publications

Induction of Bronchial Tolerance After 1 Cycle of Monophosphoryl-A-Adjuvanted Specific Immunotherapy in Children With Grass Pollen Allergies

Induction of Bronchial Tolerance After 1 Cycle of Monophosphoryl-A-Adjuvanted Specific Immunotherapy in Children With Grass Pollen Allergies

Lolium perenne peptide immunotherapy is well tolerated and elicits a protective B‐cell response in seasonal allergic rhinitis patients

Long‐term effects: Galectin‐1 and specific immunotherapy for allergic responses in the intestine

Contact Info

Product

Resources

About