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PubMedDate not supplied

Topical nasal immunotherapy. Immunologic response of IgE in nasal secretion after immunotherapy with Dermatophagoides pteronyssinus.

We studied 9 children between 9 and 14 years old who had been diagnosed with exclusive allergic rhinitis and were sensitive to acari. Topical nasal immunotherapy for D. pteronyssinus was carried out for 2 years. The total IgE in nasal secretions measured before immunotherapy showed levels of 14.2 to 85.2 IU/ml, and the specific IgE in nasal secretion against D. pteronyssinus and D. farinae ranged from 0.6 to 8.86 PRU (classes II and III). After the immunotherapy the total IgE in nasal secretion fell in 8 of the 9 children (average 24.2 IU/ml. Range 5.6 to 53.3 IU/ml). The specific IgE against D. pteronyssinus rose in 6 children and fell in 3, and all but one of the children remained in class II-III. The tolerance to the immunotherapy was good in all the children.

Administration, Intranasal↗

PubMed1984

[Tumor-specific immunotherapy: active immunotherapy by augmenting the induction of tumor-specific effector T cells through a T-T cell interaction mechanism].

Recent progress in tumor-specific immunotherapy was reviewed. Methods involved include a) utilization of tumor-specific monoclonal antibodies in conjugation with various anti-cancer agents, b) adoptive transfer of anti-tumor effector T cell clones elaborated in vitro in the presence of interleukin-2 and c) active tumor-specific immunotherapy by augmenting the generation of tumor specific effector T cells. This paper focused especially on the amplified induction of tumor-specific immunity by T-T cell interaction between helper T cells and anti-tumor effector T cells. Data were provided indicating successful tumor-specific immunotherapy in autochthonous as well as syngeneic tumor models and such results were discussed in the light of the future clinical application of the tumor-specific active immunotherapy.

Animals↗

PubMedDate not supplied

Venom immunotherapy: tolerance to a 3-day protocol of rush-immunotherapy.

In the last 10 years in the Ramón y Cajal Hospital, in Madrid, we have treated 78 patients who had presented anaphylactic reactions after hymenoptera stings, by means of a rush immunotherapy protocol. Fifty patients received wasp venom and 30 received honeybee venom (2 patients were treated with both venom types). Venom immunotherapy is given to out-patients, at the hospital, in the morning. The interval between injections administered on the same day is 30 minutes and the patient stays for 2 hours under observation after the last daily dose. The schedule we use is as follows: Day 1 (0.05-1-5-10 micrograms of venom), Day 2 (20-40 micrograms), Day 3 (40-60 micrograms), Day 5 (100 micrograms). Afterwards, they receive 100 micrograms after 2 weeks and, finally, monthly. In order to achieve a better tolerance, patients are protected with antihistamines on the days they are administered the immunotherapy (mequitazine 5 mg every 12 hours) and also, doses equal or over 40 micrograms are given fractionally, injecting half dose in each arm. The percentage of systemic reactions (mild or moderate) is 13.3% for patients treated with honeybee venom and 2% for patients treated with wasp venom. These percentages are lower than those obtained with conventional protocols in which it takes several weeks to reach the maintenance dose. The speed and convenience of this protocol and also its appropriate safety have led us to use it as a routine treatment for patients who require venom immunotherapy after suffering anaphylactic reactions due to hymenoptera stings.

Anaphylaxis↗

PubMed2006

Economic evaluation of sublingual immunotherapy vs symptomatic treatment in adults with pollen-induced respiratory allergy: the Sublingual Immunotherapy Pollen Allergy Italy (SPAI) study.

BACKGROUND: Few data are available on the pharmacoeconomic aspects of immunotherapy. OBJECTIVE: To evaluate, from the health care system and societal perspectives, the costs and consequences of sublingual immunotherapy (SLIT) added to pharmacotherapy compared with drugs alone for respiratory allergy. METHODS: This study compared costs, clinical outcomes, and cost-effectiveness ratios of 2 strategies in the management of allergic rhinitis and asthma, namely, SLIT associated with pharmacotherapy and pharmacotherapy alone (no SLIT). A decision tree was developed and populated with epidemiologic and resource utilization data concerning approximately 2,200 patients. Direct costs included visits, tests, pharmacotherapy, immunotherapy, and hospitalizations. Indirect costs and out-of-pocket drugs were also included. Outcome was calculated as the number of improved patients and asthma cases avoided at 6 years. Sensitivity analysis was performed by varying costs and epidemiologic data. RESULTS: SLIT improved the symptoms of 399 of 1,000 patients and prevented asthma in 229 of 1,000 patients compared with drugs alone. For SLIT added to pharmacotherapy and pharmacotherapy alone, the direct cost per patient at more than 6 years was Euro2,400 and Euro3,026, whereas the indirect cost was Euro1,913 and Euro3,400. CONCLUSION: From both perspectives and for both effectiveness end points, SLIT is less expensive and more effective than pharmacotherapy alone.

Administration, Sublingual↗

PubMed2001

Chemo-immunotherapy and chemo-adoptive immunotherapy of cancer.

The chemo-immunotherapy (CIT) and chemo-adoptive immunotherapy (CAIT) regimens tested in the past decade are summarized. From them we have learned a great deal about the interactions between various chemotherapeutic agents, immune modulating agents and effector cells. The most commonly reported result in multi-modality experiments with CAIT has been a synergistic enhancement in antitumor activity. Clinical trials usually demonstrated improvement in patient quality of life, an extension of survival time, and occasional complete regression of tumor. In many animal models, this enhancement often meant the complete regression and apparent cure of tumor in the animal. One mechanism by which this synergistic enhancement takes place appears to be a suppression of tumor-associated suppressor T cell activity by the chemotherapeutic agents, thereby inducing enhanced cytolytic activity against tumor by the adoptively transferred, activated effector cells. In CAIT the most commonly used drug has been cyclophosphamide. In CIT a wide variety of chemotherapy agents have been used but none of the clinical trials made use of cyclophosphamide. Thus, direct comparisons are not possible. Suggestive of the intricate regulatory processes involved, many CIT studies indicate a synergy only when specific doses of chemotherapy and immunotherapy agents are given, and in a specific sequence. CIT has become less toxic, is being handled on a cost-effective outpatient basis, while maintaining similar objective response rates to earlier inpatient treatments. In the future, CAIT and CIT will probably have an increasing role in the management of patients with specific cancers.

Animals↗

PubMed1986

Diagnosis and immunotherapy of mould allergy. V. Clinical efficacy and side effects of immunotherapy with Cladosporium herbarum.

A placebo-controlled, double-blind study of immunotherapy with the mould species Cladosporium was performed in 22 adult asthmatics. The diagnosis of Cladosporium allergy was based on a combination of bronchial provocation test and daily symptom score in the Cladosporium season. An aqueous preparation of a potent, biologically standardized and purified extract was used in a clustered dose-increase regimen. The clinical efficacy was evaluated by a combination of symptoms (asthma score + peak flow) and consumption of antiasthmatic medication. The mean changes in symptoms and medication consumption over a 10-week registration period (peak Cladosporium season) in 1982 after 5-7 months of immunotherapy were compared with the corresponding 1981 pretreatment 10-week period. A significant (P = 0.03) difference in terms of "improved", "unchanged" and "deteriorated" patients in favour of Cladosporium treatment was found. Approximately 80% in the Cladosporium group showed improved/unchanged symptoms contrary to 30% of the placebo treated. Side effects were observed frequently but only in the Cladosporium-treated. About 70% experienced a large local reaction and 100% had episodes of asthma during dose-increase phase. Only a few severe systemic reactions occurred. Based on the clinical efficacy of the treatment we consider immunotherapy with Cladosporium feasible for highly specialized clinics.

Adolescent↗

PubMed2001

Immunotherapy of melanoma: a dichotomy in the requirement for IFN-gamma in vaccine-induced antitumor immunity versus adoptive immunotherapy.

The mechanism by which tumors are rejected following the adoptive transfer of tumor-specific T cells is not well characterized. Recent work has challenged the requirement for cytotoxicity mediated by either the perforin/granzyme or Fas/Fas ligand pathway in T cell-mediated tumor regression. Many reports, including ours, suggest that tumor-specific production of IFN-gamma is critical for T cell-mediated tumor regression. However, in most of these studies the evidence to support the role for IFN-gamma is only indirect. We have directly examined the requirement for IFN-gamma using IFN-gamma knockout (GKO) mice. The results show an interesting dichotomy in the requirement for IFN-gamma: Antitumor immunity induced by active-specific immunotherapy (vaccination) required IFN-gamma, whereas adoptive immunotherapy did not. In GKO mice vaccination with the GM-CSF gene-modified B16BL6-D5 tumor (D5-G6) failed to induce protective immunity against parental D5 tumor. However, adoptive transfer of effector T cells from GKO mice cured 100% of GKO mice with established pulmonary metastases and induced long term antitumor immunity and depigmentation of skin. Furthermore, in vivo neutralization of IFN-gamma by mAb treatment or adoptive transfer into IFN-gamma receptor knockout mice failed to block the therapeutic efficacy of effector T cells generated from wild-type or perforin knockout mice. Analysis of regressing metastases revealed similar infiltrates of macrophages and granulocytes in both wild-type and GKO mice. These results indicate that in this adoptive immunotherapy model, neither a direct effect on the tumor nor an indirect effect of IFN-gamma through activation of myeloid or lymphoid cells is critical for therapeutic efficacy.

Animals↗

PubMed1994

Worldwide collaborative observational study and meta-analysis on allogenic leukocyte immunotherapy for recurrent spontaneous abortion. Recurrent Miscarriage Immunotherapy Trialists Group.

PROBLEM: Recurrent spontaneous abortion (RSA) is a common complication of pregnancy for which there is no known cure. Therefore, effective treatment is needed. Published results from controlled clinical trials of allogeneic leukocyte immunization of women suffering from RSA have given conflicting results. To address this controversy, the international raw data of all patients who had been entered into clinical trials that included a control group were collected and analyzed. The primary question to be answered was whether alloimmune stimulation of the female partner improves the subsequent live birth rate. METHODS: Fifteen clinical centers were identified worldwide because they controlled appropriate raw data. Consequently, nine randomized trials (seven double-blinded) were evaluated independently by two separate data analysis teams to assure conclusions were robust. One team also compared randomized trials to the results of six nonrandomized cohort-controlled studies to test for bias in nonrandomized trials. Factors predicting successful live births among couples with RSA were evaluated by logistic regression. RESULTS: Although the two independent analyses made use of different definitions and utilized different statistical methods, the results of both were similar. The live births ratios (ratio of live births in treatment and control groups) with 95% confidence intervals (CI) were 1.16 (CI, 1.01-1.34, P = 0.031) and 1.21 (CI, 1.04-1.37, P = 0.024), respectively. The absolute differences in live birth rates between treatment and control groups were 8% and 10% in respective analyses. Results in randomized and nonrandomized trials were surprisingly similar despite significant differences in composition of control and treatment groups. Live birth rates were lower with older female partners, more than five abortions, with a positive ANA or with positive anticardiolipin antibodies. Live birth rates were higher if the female partner had prior to treatment serum antibodies to paternal leukocytes or converted from negative to positive with immunization. Approximately 0.5% of controls and 2.1% of treated patients experience side effects for a 1.6% treatment related effect. There was no evidence of an increased risk of adverse effects on the fetus. CONCLUSIONS: Two independent analyses of worldwide data on allogeneic leukocyte immunization for treatment of RSA suggest that alloimmunization may be an effective treatment The treatment effect appears, however, to be small, and the data indicate that immunotherapy helps only 8% to 10% of affected couples. A current lack of diagnostic tests defining patients who most likely would benefit from immunotherapy, precludes the identification of a patient population that would benefit most from such treatment. The efficacy of treatment in such a subgroup could be expected to increase and could be of sufficient magnitude to allow the determination of more effective immunization protocols. This study does not exclude the possibility of a partial correction of a widely prevalent immunology defect by immunotherapy. The presence of such a defect would indicate a need for more effective therapy. The unexplained variation in pregnancy success rates of control groups among centers continues to present a statistical problem, limiting the statistical evaluation of retroactively obtained data.

Abortion, Habitual↗

PubMed1987

Diagnosis and immunotherapy of mould allergy. VI. IgE-mediated parameters during a one-year placebo-controlled study of immunotherapy with Cladosporium.

The IgE-response was evaluated by skin prick test, bronchial provocation test and RAST in a 1-year placebo-controlled double-blind immunotherapy study. Eleven adult asthmatics were treated with a Cladosporium allergen preparation and 11 comparable patients received histamine placebo. The bronchial sensitivity (PC20) decrease greater than 0.5 log step in 8/11 (73%) Cladosporium-treated versus 3/11 (27%) in the placebo group. Corresponding figures for skin prick test sensitivity was 10/11 (91%) and 1/11 (9%) respectively. Circulating IgE showed a temporary boost in the Cladosporium group and then values approaching the pretreatment value. Only minimal and insignificant changes were found in the placebo-treated patients. Changes in IgE-reactivity were not related to allergen dose, clinical efficacy or to the occurrence of side effects. Some interrelation between changes in skin prick test, bronchial provocation test and RAST was found indicating a differentiated effect of immunotherapy on various IgE compartments. In spite of the pathogenetic role of IgE in allergic diseases, changes in IgE-reactivity do not seem directly involved in the mechanisms underlying the clinical efficacy of immunotherapy but might be of importance in a complex interaction with other immunological parameters.

Adult↗

PubMed1986

[Effect of immunotherapy using the non-specific immunopotentiator OK-432 in malignant ovarian tumors--selecting appropriate cases for immunotherapy].

Immunotherapy for malignant ovarian tumors has been discussed in a number of recent studies. However, the effects of this therapy are produced by an indirect mechanism, and are, therefore, difficult to evaluated. In order to select appropriate cases for immunotherapy using OK-432 against malignant ovarian tumors, clinical and experimental studies were carried out. Clinically patients with ovarian cancer were divided into two groups; OK-432 treated group and no immunotherapy groups. As a parameter of immunoresponse to OK-432, PHA and Su-PS skin tests were performed periodically. Natural killer (NK) cell activity was also measured before and after administration of OK-432. Peripheral blood lymphocyte subsets were analysed by using monoclonal antibody and a laser flow cytometer. Finally tumor growth velocity was evaluated in tumor transplanted nude mice. The survival rate was used as an index for evaluation. The survival rate of the OK-432 treated groups was better than the control groups in advanced cases, but a statistically significant difference was found between the two groups. Among fundamental studies which were carried out to select appropriate cases, Su-PS skin test, the NK response of OK-432 seemed to be actually utilized.

Animals↗

PubMed1994

[Passive immunotherapy with Venimmun for the prevention of habitual abortion--early pregnancy factor, placenta protein 12, placenta protein 14, tumor necrosis factor alpha--parameters for monitoring immunotherapy].

In a study it was investigated to what extent the early pregnancy factor, the placental proteins 12 and 14 and tumor necrosis factor alpha are suited to control and select patients with habitual abortions for immunotherapy. Immunotherapy shows good clinical results. Placental protein 12 ist not suited for selecting patients. Placental protein 14 shows typical changes after the application of polyvalent immunoglobulin and could be an important prognostic factor. Tumor necrosis factor alpha seems to be useful for selecting patients for immunotherapy, because in cases of habitual abortions this factor can be a sign for immunological causes. In the late phase of pregnancy, early pregnancy factor is also an indicator for disturbances of pregnancy.

Abortion, Habitual↗

PubMed2026

An oxidative stress - and immunotherapy-related six-gene signature defines immune subtypes and predicts prognosis and immunotherapy response in hepatocellular carcinoma.

BACKGROUND: Oxidative stress and the tumor immune microenvironment jointly shape hepatocellular carcinoma (HCC) progression and response to immunotherapy, yet integrated biomarkers linking these processes are lacking. METHODS: Transcriptomic and clinical data from The Cancer Genome Atlas (TCGA) and Gene Expression Omnibus (GEO) datasets were used to identify oxidative stress- and immunotherapyrelated differentially expressed genes (OSIRDEGs). Functional enrichment, weighted gene co-expression network analysis (WGCNA) and LASSO-Cox regression were used to construct a prognostic signature. Consensus clustering, TIDE, CIBERSORT and ssGSEA characterized immune phenotypes. Somatic mutation, copy-number and drug-response data were integrated to assess genomic alterations and drug sensitivity. Expression of model genes was validated by qRT-PCR and western blotting in HCC cell lines. RESULTS: We identified 24 OSIRDEGs enriched in cell-cycle and mitotic pathways. WGCNA intersection yielded 18 module genes, from which a six-gene signature (BUB1B, CDKN2A, CENPE, HMMR, PTTG1, SPP1) was derived. The signature robustly stratified patients into high- and low-risk groups with significantly different progression-free and disease-free survival in both TCGA-LIHC and GSE14520. Based on signature expression, two molecular subtypes were defined, exhibiting distinct survival, immune landscapes and predicted immunotherapy responsiveness. Model genes harbored recurrent alterations and showed significant correlations with anticancer agents. All six genes were upregulated at mRNA and protein levels in metastatic HCC cell lines versus normal hepatocytes. CONCLUSIONS: We systematically explored the landscape of OSIRDEGs in HCC, and proposed a validated six-gene signature that refines prognostic stratification, delineates immunerelevant HCC subtypes and highlights candidate biomarkers for therapeutic selection and mechanistic investigation.

Humans↗

PubMed2001

The roles of adoptive and active forms of immunotherapy in the cure of children suffering from acute lymphoid leukemia: a) underestimation of active immunotherapy benefit, b) its immunogenetic indications to select sensitive patients, hence prevent chemotherapy's late effects.

Children's acute lymphoid leukemia (ALL) chemotherapy started in 1948 with antimetabolites combined with steroids. It was enriched in 1959 with vincristine and cyclophosphamide and, in 1970, with daunomycin. It induced more and more apparently what were called complete remissions, and prolonged more and more the survivals without reducing however, until 1973, the (100%) mortality. It started to reduce it at the fifth year, to 20 and even 40% between 1973 and 1976, due to progressive and maximal intensification and duration of chemotherapy. It is in the same period that we proposed to apply in ALL remissions after relapses and in the first remissions of the most malignant type, allogeneic bone marrow grafts; we published the first success in human ALL in 1963, and clinically observed the same actions as those described experimentally: cytoablation of both leukemia and hematopoiesis, the latter being restored by the graft, whose reaction versus the residual neoplastic cells (called graft versus leukemia or GvL) appeared to be able to often eradicate them, at the cost however of a graft-versus-host reaction (both reactions sharing the same mechanism). One of us became a member of the Committee of the International Bone Marrow Transplant Registry, whose results showed the improvement in the prognosis of the aggressive form of ALL. The intensity and length established for chemotherapy for the most severe form of children's ALL have often been applied to the intermediary and to the least aggressive ones. The global 5-year survival increased to 60% between 1976 and 1984, and is around 80% today. But the registration of late debilitating or malignant effects of chemotherapy toxicities makes us wonder if some patients have not received an excessively intense and long application of cytostatics (often combined with ionizing radiations on CNS). In fact, the patients belonging to some HLA phenotypes (A33 and B17) have appeared to be especially often cured with active immunotherapy (killed leukemic cells and/or BCG), whose action was shown by specific cytotoxicity amplification, which was applied after short adjuvant chemotherapy, and hence is able to reduce the long chemotherapy incidence of debilitating or malignant late effects. Sakurai's group confirmed our absence of late relapses after ALL active immunotherapy, which contrasts with their risk after maintenance chemotherapy, whose minimal residual disease is a worrisome stumbling block to the cure.

Antineoplastic Agents↗

PubMed1996

Pre-immunotherapy serum CA27.29 (MUC-1) mucin level and CD69+ lymphocytes correlate with effects of Theratope sialyl-Tn-KLH cancer vaccine in active specific immunotherapy.

Patients with metastatic breast, colorectal or ovarian cancers received active specific immunotherapy (ASI) with Theratope sialyl-Tn-KLH (keyhole limpet hemocyanin) cancer vaccine emulsified in Detox adjuvant. The median log2 anti-STn IgG titer generated by ASI, estimated by enzyme-linked immunosorbent assay with solid-phase ovine submaxillary mucin, was 5.322 (range = 0 - 9.322). Following ASI, 51 patients who generated titers higher than the median value for anti-STn+ mucin IgG survived longer than 46 patients who generated lower titers below the median. 38 of the patients were phenotyped for CD69 prior to ASI. The patients with lower numbers of CD69+ peripheral blood lymphocytes prior to immunotherapy (pre-ASI) also had low serum CA27.29 cancer antigen (MUC-1) levels, and had longer times to disease progression and improved survival following ASI. Elevated pre-ASI serum CA27.29 tumor antigen levels were associated with higher numbers of CD69+ PBL, with decreased anti-STn antibody production and decreased survival following ASI. The data are compatible with the hypothesis that elevated serum MUC-1 mucin is specifically immunosuppressive.

Antigens, CD↗

PubMed2004

Immunotherapy for malignant gliomas: emphasis on strategies of active specific immunotherapy using autologous dendritic cells.

REVIEW: In this review, we discuss immunotherapy for malignant gliomas. EMPHASIS: The emphasis is on the novel strategy of active specific immunotherapy using dendritic cells as antigen-presenting cells, especially its theoretical concepts and advantages, specific requirements, critical issues, pre-clinical and early clinical experience. Dendritic cell vaccination is situated in the diversity of other immunotherapeutical approaches. FURTHER DISCUSSION: Future directions, challenges, and drawbacks will be discussed.

Animals↗

PubMed1988

Double-blind, placebo-controlled immunotherapy with mixed grass-pollen allergoids. II. Comparison between parameters assessing the efficacy of immunotherapy.

Specific immunotherapy is effective in alleviating symptoms in grass pollen-induced rhinitis, but there are no clear data demonstrating a correlation between symptom-medication scores and objective parameters. Twenty-five patients taking part in a double-blind, placebo-controlled immunotherapy with mixed grass pollen-formalinized allergoids were studied. All patients had the same investigations. Symptom-medication scores were significantly (p less than 0.005, Mann-Whitney U test) reduced in the treated group by comparison to the placebo-treated patients. Nasal challenges performed with threefold increasing numbers of orchard grass-pollen grains demonstrated that patients treated with allergoid tolerated a significantly (p less than 0.005, Wilcoxon W test) greater number of grains after treatment, whereas there was no mean difference in the placebo-treated patients. There was a significant (p less than 0.005, Spearman rank-correlation) correlation between nasal challenges and symptom scores during the season. The skin prick test end point was significantly (p less than 0.001, Wilcoxon W test) reduced after treatment in the allergoid-treated group and remained unchanged in the placebo-treated group. There was a significant (p less than 0.001) correlation between the skin prick test end point and symptom scores during the season. Serum grass-pollen IgG titrated by a solid-phase radioimmunoassay with Staphylococcus A protein was significantly (p less than 0.01, Wilcoxon W test) increased after treatment with allergoid, but there was no significant correlation between IgG titer and symptom scores during the season. Serum grass-pollen IgE increased (p less than 0.04, Wilcoxon W test) in the treated group but there was no correlation with symptom scores.

Adult↗

PubMed1989

Hymenoptera venom immunotherapy. I. Induction of T cell-mediated immunity by honeybee venom immunotherapy: relationships with specific antibody responses.

The specific cell-mediated and humoral immune responses of 14 children allergic to honeybee venom were studied. An 8-day rush venom immunotherapy induced an increase in T proliferative (p less than 0.04) and T suppressive (p less than 0.003) cell-specific activities. Antibody variations, an increase in specific IgG4 (p not equal to 0.05), and a decrease in specific IgE (p less than 0.01) were observed 1 year later. Initial high T suppressive cell activity prevents T proliferative cell increase during rush venom immunotherapy. High initial levels of specific IgG1 and specific IgG4 have opposing effects on the increase in T suppressive cell activity, the former being positively correlated with intensive increase (r = 0.840; p less than 0.005), the latter negatively with T suppressive cell increase (r = -0.709; p less than 0.001). These data indicate that there are interrelationships between the cell-mediated immunity and the antibody responses in honeybee allergy.

Adolescent↗

PubMed1990

Immunotherapy with a standardized Dermatophagoides pteronyssinus extract. IV. Systemic reactions according to the immunotherapy schedule.

Specific immunotherapy with standardized extracts can induce systemic reactions (SRs), possibly increased by a rush immunotherapy (RIT) protocol. A prospective study in 1152 mite-allergic patients (3 to 63 years of age) examined the incidence of SRs during an RIT or a step protocol. All patients received the same standardized extract of Dermatophagoides pteronyssinus with the same maintenance dose. In the first group, 290 patients had an RIT protocol without any preventive measure. In a second group, the prevention of SRs during RIT was attempted by pretreating 160 patients with methylprednisolone (0.5 mg/kg/day), ketotifen (2 mg/day), and theophylline (10 mg/kg/day). In a third group (479 patients), the same pretreatment was associated with preventive measures and with FEV1 results and the occurrence of large local reactions. A fourth group consisted of 223 patients who received a step protocol with the same pretreatment and preventive measures. The incidence of SRs per patient was 36.2% with RIT alone, 16.2% when the pretreatment was added, and 7.2% when pretreatment and preventive measures were used. Patients receiving the step protocol had 5.4% SRs. Adrenaline had to be used from 10.0%, 4.6%, 0.2%, and 0.2%, respectively. No reaction started 45 minutes or later after the last injection. Children younger than 5 years of age had a significantly greater number of SR.

Adolescent↗