Specific subcutaneous immunotherapy with recombinant grass pollen allergens: first randomized dose‐ranging safety study

Klimek, Ludger; Schendzielorz, Philipp; Piñol, Ramón A.; Pfaar, Oliver

doi:10.1111/j.1365-2222.2012.03971.x

Cited by 55 publications

(32 citation statements)

References 35 publications

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“…Results of trials investigating COPs demonstrated greater improvements in rhinoconjunctivitis symptom scores using 5 injections with 50 μg than with 100 μg ( P = .015) 4, 26. Klimek et al27 reported the highest percentages of CPT response threshold improvements (90% of patients) in the group receiving lower doses of a recombinant 5‐grass pollen SCIT (40 μg) compared to 50% improvement under placebo ( P = .466).…”

Section: Discussionmentioning

confidence: 99%

“…Fifty per cent of control group patients in the study by Klimek et al exhibited decreased CPT reactivity after receiving placebo. The authors argued that post‐treatment reprovocations at threshold doses from baseline (without prior up‐dosing and less cumulative allergen) were a possible cause 27. Jutel et al1 were unable to demonstrate significantly different CPT results between placebo and actively treated groups, with 53.8% of the placebo group patients having higher CPT response thresholds.…”

Section: Discussionmentioning

confidence: 99%

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A randomized, double‐blind, placebo‐controlled, dose‐finding trial with Lolium perenne peptide immunotherapy

Mösges

Kasche

Raskopf

et al. 2017

Allergy

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BackgroundA novel subcutaneous allergen immunotherapy formulation (gpASIT+™) containing Lolium perenne peptides (LPP) and having a short up‐dosing phase has been developed to treat grass pollen–induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity and safety.MethodsThis prospective, double‐blind, placebo‐controlled, phase IIb, parallel, four‐arm, dose‐finding study randomized 198 grass pollen–allergic adults to receive placebo or cumulative doses of 70, 170 or 370 μg LPP. All patients received weekly subcutaneous injections, with the active treatment groups reaching assigned doses within 2, 3 and 4 weeks, respectively. Efficacy was assessed by comparing conjunctival provocation test (CPT) reactions at baseline, after 4 weeks and after completion. Grass pollen–specific immunoglobulins were analysed before and after treatment.ResultsConjunctival provocation test (CPT) response thresholds improved from baseline to V7 by at least one concentration step in 51.2% (170 μg; P = .023), 46.3% (370 μg), and 38.6% (70 μg) of patients receiving LPP vs 25.6% of patients receiving placebo (modified per‐protocol set). Also, 39% of patients in the 170‐μg group became nonreactive to CPT vs 18% in the placebo group. Facilitated allergen‐binding assays revealed a highly significant (P < .001) dose‐dependent reduction in IgE allergen binding across all treatment groups (70 μg: 17.1%; 170 μg: 18.8%; 370 μg: 26.4%). Specific IgG4 levels increased to 1.6‐fold (70 μg), 3.1‐fold (170 μg) and 3.9‐fold (370 μg) (mPP).ConclusionThree‐week immunotherapy with 170 μg LPP reduced CPT reactivity significantly and increased protective specific antibodies.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A randomized, double‐blind, placebo‐controlled, dose‐finding trial with Lolium perenne peptide immunotherapy

Mösges

Kasche

Raskopf

et al. 2017

Allergy

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“…It is more effective with perennial rather than with preseasonal conditioning although the safety profile is similar [82]. No major side effects have been reported with doses as high as 120 mg [83]. It has been shown to be more effective than topical treatment both in terms of subjective symptoms and objective inflammation (serum immunoglobulin IgE) in VKC [84].…”

Section: Immunotherapymentioning

confidence: 99%

Treatment of ocular allergies: nonpharmacologic, pharmacologic and immunotherapy

Bilkhu

Naroo

Wolffsohn³

2015

Expert Review of Ophthalmology

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Ocular allergy is a significant and growing issue worldwide but for many patients, it is often not differentiated from systemic conditions, such as hay fever. Management of seasonal and perennial allergic conjunctivitis is often poor. Management is principally through avoidance measures (blocking or hygiene), nonpharmaceutical (such as artificial tears and cold compresses) and pharmaceutical (such as topical antihistamines and prophylactic mast cell stabilizers). Vernal and atopic keratoconjunctivitis are more severe and generally need treatment with NSAIDs, steroids and immunomodulators. Giant papillary conjunctivitis can be related to allergy but also is often contact lens related and in such cases can be managed by a period of abstinence and replacement of the lens or a change in lens material and/or design. Immunotherapy can be efficacious in severe, persistent cases of contact lens or allergic conjunctivitis.KEYWORDS: antihistamine . atopic keratoconjunctivitis . giant papillary conjunctivitis . immunotherapy . mast cell stabilizer . ocular allergy . perennial allergic conjunctivitis . seasonal allergic conjunctivitis . vernal keratoconjunctivitis Allergic eye disease is the ocular manifestation of allergy, where the immune system produces an over-reaction or hypersensitivity to normally harmless substances known as allergens. The prevalence of allergy has shown a significant increase and appears to be plateauing across the world at a level between 15 and 20% [1,2]. Although genetics plays an important role in susceptibility, the increase in prevalence is suggested to be the result of improved hygiene practices and increased antibiotic use as a part of modern lifestyle and health care [3], in addition to environmental factors, such as increased air pollution, climate change and increased planting and importation of allergenic plant species [4,5]. Indeed, the effect of the environment is now considered a very strong influence on allergy prevalence; recent studies have shown that although migration to a new environment initially decreases prevalence in that area, it steadily increases to match that of the host country over time [6].Of those who suffer from allergy, approximately 15-20% experience a form of ocular response [7,8] and around 65% of those with rhinoconjunctivitis report ocular signs [9][10][11]. However, several authors have pointed out that ocular allergies may be underdiagnosed and undertreated, particularly seasonal allergic conjunctivitis (SAC), where the ocular symptoms may fall under the umbrella of seasonal hay fever, which may underestimate its true prevalence [9,12,13]. Ocular allergy encompasses a group of distinct clinical entities, typically confined to the conjunctiva, and includes allergic conjunctivitis (AC), which is subdivided into seasonal (SAC) and perennial forms (PAC), vernal keratoconjunctivitis (VKC), atopic keratoconjunctivitis (AKC) and giant papillary conjunctivitis (GPC) [12].Epidemiology AC is a classic Type I, IgE-mast cell-mediated hypersensitivity disorder and the m...

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“…Entwicklungen im Bereich von rekombinanten Wildtypallergenen und hypoallergen modifizierten Allergenen sowie im Bereich der Peptidtherapie scheinen vielversprechend [35,36]. Rekombinante Allergene wurden erstmals im Jahre 1988 hergestellt [37,38].…”

Section: Individualisierung In Der Allergologie: Spezifische Immuntheunclassified

Individualisierte, personalisierte, stratifizierte Medizin: eine Herausforderung für die Allergologie in der HNO?

Chaker

Klimek

2015

HNO

Self Cite

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Individualized, personalized or stratified medicine approaches offer emerging opportunities in the field of allergy and ENT. Avoidance of side effects, targeted therapy approaches and stratified prevention promise better outcomes and optimal results for patients. Conceptual incongruencies remain with regard to definitions and perceptions of "personalized medicine". Serious ethical considerations have to be taken into account. The development of pharmacogenomics, molecular phenotyping, genomic sequencing and other -omics opens the door to unique mechanistic therapeutic advances. The molecular allergology and recombinant diagnostics available are tools that offer substantial improved diagnostics for the benefit of allergic patients, e. g. in anaphylaxis and food allergy. For stratified therapeutic approaches, however, regulatory affairs will have to keep pace with medical and scientific discovery.

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Specific subcutaneous immunotherapy with recombinant grass pollen allergens: first randomized dose‐ranging safety study

Abstract: The first DBPC SCIT-DRF with a mixture of recombinant Phleum allergens (Phl p 1, 2, 5a, 5b, 6) in patients with rhinoconjunctivitis plus/minus asthma showed no major side effects in very high doses up to 120 μg.

Cited by 55 publications

References 35 publications

A randomized, double‐blind, placebo‐controlled, dose‐finding trial with Lolium perenne peptide immunotherapy

A randomized, double‐blind, placebo‐controlled, dose‐finding trial with Lolium perenne peptide immunotherapy

Treatment of ocular allergies: nonpharmacologic, pharmacologic and immunotherapy

Individualisierte, personalisierte, stratifizierte Medizin: eine Herausforderung für die Allergologie in der HNO?

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