Immunotherapy with Alutard SQ reduced symptoms and need for medication in severe summer hay fever
ACP J Club. 1991 May-June;114:81. doi:10.7326/ACPJC-1991-114-3-081
Varney VA, Gaga M, Frew AJ, et al. Usefulness of immunotherapy in patients with severe summer hay fever uncontrolled by antiallergic drugs. BMJ. 1991;302:265-9. [PubMed ID: 1998791]
To evaluate the effectiveness and safety of immunotherapy in patients with severe summer hay fever.
Randomized, double-blind, placebo-controlled trial of 8 months' duration.
Allergy and clinical immunology clinic, London, England.
40 adults who were suffering from severe summer hay fever with poor symptom control in previous years despite regular treatment and a positive skin test result to timothy grass pollen extract. Patients with chronic asthma, other appreciable allergies, or previous immuno- therapy were excluded. 37 patients (93%) completed the study.
Patients were stratified by symptom severity as extremely hypersensitive or very hypersensitive, then randomly allocated to receive either active treatment (Alutard SQ, a grass pollen [Phleum pratense] extract) (n = 21) or placebo (n = 19). Immunotherapy was administered by subcutaneous injection.
Main outcome measures
Self-reporting of daily symptom scores (scale, 0 to 3) and drug requirements; visual analog score (scale, 0 to 10) of overall hay fever symptoms; end of pollen season assessment of hay fever compared with other years by both study coordinator and patients (scale, -3 to +3); and skin and conjunctival test reactions recorded before and after pollen season.
Median symptom scores decreased in the Alutard-SQ-treated group compared with the placebo group (360 vs 928, 95% CI for the 568-point difference, 238 to 825, P = 0.001). Median medication requirements were lower in the active-treatment group for eyedrops (14 vs 128, P = 0.01), nasal spray (78 vs 232, P = 0.01), acrivastine (80 vs 174, P = 0.04), and oral prednisolone (0 vs 54, P = 0.001). Overall hay fever symptom scores were lower for the Alutard SQ group (at peak season, 2.2 vs 5.5; absolute difference -3.3; CI -4.8 to -0.5, P = 0.02). Postseasonal assessment by both patients and the study coordinator showed improvement in favor of Alutard SQ (P < 0.001). Conjunctival allergen sensitivity tests and skin provocation test results also favored Alutard SQ. 1 immediate anaphylactic reaction and 1 delayed reaction of mild urticaria occurred in the Alutard-treated group, and 2 delayed systemic reactions (dyspnea and dizziness) occurred in the placebo group.
Immunotherapy with Alutard SQ is effective in reducing symptoms and requirements for medication in severe hay fever sufferers. The possibility of immediate anaphylactic reactions suggests immunotherapy should only be administered in specialized centers.
Source of funding: National Asthma Campaign/MRC UK.
Address for article reprint: Dr. S.R. Durham, Allergy Clinic, Royal Brompton and National Heart and Lung Hospital, London, England SW3 6HP, UK.
Many clinical studies over the past 20 years have documented the efficacy of immunotherapy in the treatment of allergic rhinitis. However, in the United Kingdom and elsewhere, there is increasing concern regarding the risk (anaphylaxis)-benefit (symptomatic relief) relationship of this treatment. Varney and associates studied patients with severe hay fever who failed conventional treatment (including intranasal corticosteroids and sodium cromoglycate). This clinical study was carefully conducted using biologically standardized testing reagents and immunotherapy extracts. There was statistically and clinically significant improvement in the immunotherapy- treated group by virtually all criteria. The adverse reaction rates in the placebo and active-treatment groups were similar and infrequent, and all 4 reactions resolved without sequelae. The single immediate systemic reaction in a patient receiving active immunotherapy responded promptly to epinephrine.
This study shows that patients with the most severe hay fever can benefit from immunotherapy. It is worth noting that the aluminum- absorbed timothy grass pollen extract used in this study is not generally available in the United States. Nevertheless, these findings can probably be generalized to other standardized grass pollen extracts and probably to other types of nasal allergy, especially if standardized extracts are available. In a follow-up study, patients were randomized to continuation of immunotherapy for another 3 years, or discontinuation of immuno- therapy with placebo (1). A matched group of patients with severe allergic rhinitis who never received immunotherapy was used as the control group. This follow-up study showed that seasonal symptoms and rescue antiallergic medication use remained low after discontinuation of immunotherapy. Thus, immunotherapy for grass pollen allergy induced a clinical remission for at least 3 years after discontinuation of immunotherapy.
Conservative physicians may wish to consider immunotherapy only for those patients with severe hay fever who have failed adequate trials with corticosteroid or cromolyn nasal sprays. Other physicians may wish to offer immunotherapy to patients with much milder disease with the intent of inducing a clinical remission.
James T.C. Li, MD, PhD
Mayo ClinicRochester, Minnesota, USA.