Double-blind, placebo-controlled immunotherapy with mixed grass-pollen allergoids I. Rush immunotherapy with allergoids and standardized orchard grass-pollen extract

Bousquet, Jean; Hejjaoui, A.; Skassa-Brociek, W.; Guérin, Bernard; Maasch, H.J.; Dhivert, H.; Michel, François‐Bernard

doi:10.1016/0091-6749(87)90013-3

Cited by 107 publications

(44 citation statements)

References 16 publications

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“…The number of adverse reactions found (both local as well as systemic) coincides with that reported by authors who perform rush IT (3,19). It is slightly superior to that presented in conventional IT although, for the study design, we considered it advantageous to begin an initial rapid regimen with aqueous extract.…”

Section: Discussionsupporting

confidence: 76%

“…In patients in the placebo group, the test was positive with a similar concentration at the beginning of the study. We agree with other authors on the efficacy of IT in the treatment of extrinsic asthma and/or rhinitis by sensitization to pollens (3,14). In our study, the improvement of conjunctival and bronchial symptoms was significant from the first year of treatment.…”

Section: Discussionsupporting

confidence: 74%

“…We believe that the in vivo tests chosen are well accredited in the follow-up of IT (3,5,6,12,13), and their statistical significance for cutaneous tests as well as for conjunctival and bronchial provocation tests leaves no doubt of the benefit of the treatment in the active group in comparison to the placebo group, as shown in Fig. I .…”

Section: Discussionmentioning

confidence: 99%

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

Dolz

Martínez-Cócera

Bartolomé

et al. 1996

Allergy

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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.Allergy 1996: 51: 489-500. 0 Munksgaard 1996.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.

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Section: Discussionsupporting

confidence: 76%

Section: Discussionsupporting

confidence: 74%

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

Dolz

Martínez-Cócera

Bartolomé

et al. 1996

Allergy

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“…These studies can be subdivided into 13 studies (5,7,9,11,12,15,17,19,22,32,35,36,39) investigating ragweed allergy (nine showing clinically relevant efficacy, i.e., symptom/medication scores diminished by >30% in the actively treated). Fifteen studies investigated the efficacy of immunotherapy in grass-pollen allergy (8,13,16,18,20,21,23,25,30,34,37,38,40,44,47), of which 14 proved efficacy. Nine studies investigated other pollen allergens: mountain cedar (10,27,29), Parietaria (42,43,46), Cupressus (45), Cocos (41), and mixtures (6); efficacy was demonstrated in six.…”

Section: Clinical Efficacy Of Immunotherapy In Rhinitismentioning

confidence: 99%

Immunotherapy as an effective tool in allergy treatment

Mailing¹

1998

Allergy

154

100

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“…The main reasons for excluding studies were lack of double-blinding/ randomization, review articles, multiple allergen extracts, outcomes unrelated to efficacy and preparations that are not commercially available. These criteria excluded early allergoid studies (51)(52)(53)(54)(55), a study with a recombinant allergen (which is not commercially available) (56), a paediatric SCIT study in which a combined asthma symptom-medication score was the primary outcome measure (57) and, regretfully, the 'Preventive Allergy Treatment' (PAT) study (58). Even though the 10-year PAT study was well designed and asked an important clinical question (does SCIT for allergic rhinoconjunctivitis prevent the development of asthma?…”

Section: Resultsmentioning

confidence: 99%

Towards evidence‐based medicine in specific grass pollen immunotherapy

Calderón

Mösges

Hellmich

et al. 2010

Allergy

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To cite this article: Calderon M, Mö sges R, Hellmich M, Demoly P. Towards evidence-based medicine in specific grass pollen immunotherapy. Allergy 2010; 65: 420-434.We performed a systematic, evidence-based medicine (EBM) review of double-blind, placebo-controlled randomized clinical trials (DBPC RCTs) of commercially available grass pollen-specific immunotherapy (SIT) modalities for the treatment of seasonal allergic rhinoconjunctivitis (SAR) in adults and children (1). This health problem affects as many as one in seven of the population in Western countries (2, 3), with grass pollen as one of the major triggers (4).Fundamental regulatory and technological changes are modifying the types of specific subcutaneous or sublingual SIT (SCIT and SLIT) product available to specialist practitioners. The European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) have issued guidelines affecting the clinical development of SIT products (5, 6). With the exception of Gramineae grass pollen extract SLIT tablets (currently being registered across Europe as pharmaceutical specialties), SIT products are sold as either unregistered, named patient preparations or nationally registered formulations. Hence, in many European countries, the specialist physician initiating grass pollen SIT has to choose (in collaboration with the patient) between nonregistered and registered modalities. To inform that choice, we used an EBM approach to assess commercially available immunotherapy modalities.Evidence-based medicine has been defined as 'the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient' (7) and 'the integration of the best available research evidence with clinical expertise and patient values ' (8 AbstractWhen initiating grass pollen immunotherapy for seasonal allergic rhinoconjunctivitis, specialist physicians in many European countries must choose between modalities of differing pharmaceutical and regulatory status. We applied an evidence-based medicine (EBM) approach to commercially available subcutaneous and sublingual Gramineae grass pollen immunotherapies (SCIT and SLIT) by evaluating study design, populations, pollen seasons, treatment doses and durations, efficacy, quality of life, safety and compliance. After searching MEDLINE, Embase and the Cochrane Library up until January 2009, we identified 33 randomized, double-blind, placebo-controlled trials (including seven paediatric trials) with a total of 440 specific immunotherapy (SIT)-treated subjects in seven trials (0 paediatric) for SCIT with natural pollen extracts, 168 in three trials (0 paediatric) for SCIT with allergoids, 906 in 16 trials (five paediatric) for natural extract SLIT drops, 41 in two trials (one paediatric) for allergoid SLIT tablets and 1605 in five trials (two paediatric) for natural extract SLIT tablets. Trial design and quality varied significantly within and between SIT modalities. The multinational, rigorous trials of natural extract SLIT ...

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Double-blind, placebo-controlled immunotherapy with mixed grass-pollen allergoids I. Rush immunotherapy with allergoids and standardized orchard grass-pollen extract

Cited by 107 publications

References 16 publications

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

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

Immunotherapy as an effective tool in allergy treatment

Towards evidence‐based medicine in specific grass pollen immunotherapy

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