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H-J Malling

Publications and source records attributed to H-J Malling.

10 recordsLinked to original sources
PubMed2006

Side-effects of allergen-specific immunotherapy: a prospective multi-centre study.

BACKGROUND AND OBJECTIVE: The safety of allergen-specific immunotherapy (SIT) is a parameter of great interest in the overall assessment of the treatment. A clinical database was developed in order to obtain early warnings of changes in the frequency and severity of side-effects and sufficient data for the evaluation of possible risk factors. METHODS: During a 3-year period, four allergy centres in Copenhagen, Denmark, included data from all patients initiating SIT to a common database. Information on initial allergic symptoms, allergens used for treatment, treatment regimens and systemic side-effects (SSEs) during the build-up phase was collected. RESULTS: A total of 1,038 patients received treatment with 1,709 allergens (timothy, birch, mugwort, house dust mite (HDM), cat, and wasp and bee venom), 23,047 injections in total. Most SIT patients completed the updosing phase without side-effects, but there was a significant difference between allergens: wasp (89%), birch (82%), HDM (81%), cat (74%) and grass (70%) (P=0.004). A total of 582 SSEs were registered in 341 patients. Most side-effects were mild grade 2 reactions (78%). A difference in severity between allergens was observed (P=0.02), with grass giving most problems. The type of allergen but not patient- or centre-related parameters seemed predictive of side-effects. CONCLUSIONS: Allergen extracts differ in their tendency to produce side-effects. Multi-centre studies like the present one allow more patients to be evaluated, and thereby provide a more efficient surveillance of side-effects. Online Internet-based registration to a central national database of every allergen injection would be an even more powerful tool for evaluation of risk factors and surveillance of side-effects.

Adolescent↗
PubMed2006

Sublingual immunotherapy: efficacy--methodology and outcome of clinical trials.

Using Medline we identified 39 placebo-controlled, double-blind sublingual immunotherapy (SLIT) studies providing symptom-medication score. These were retrospectively evaluated for evidence of clinical efficacy and quality of study presentation. Clinical efficacy was estimated according to statistical significance and graded as: unequivocal efficacy (statistically significant difference from placebo in both symptom and medication scores or the combined score), which was observed in 28% of studies, possible efficacy (significant improvement in either symptom or medication scores) seen in 33%, and no efficacy (no statistical difference between active treatment and the placebo group), as found in 38% of studies. Generally, studies were limited by the number of patients, showed a high frequency of withdrawals, a short duration of treatment, and insufficient data on randomization. The magnitude of efficacy additional to placebo treatment must be >20% in order to justify the treatment. This review concludes that future SLIT studies should be planned in accordance with international recommendations in order to be conclusive.

Administration, Sublingual↗
PubMed2006

Safety and tolerability of grass pollen tablets in sublingual immunotherapy--a phase-1 study.

BACKGROUND: A single-centre, randomized, double-blind, placebo-controlled study. AIMS: To compare the safety and tolerability of four different sublingual immunotherapy (SLIT) regimes in grass pollen allergic rhinitis. METHODS: Thirty subjects sensitized to grass pollen were enrolled and allocated to four groups. Sublingual immunotherapy was administered in tablets daily for 10 days. Groups 1 and 2 received incremental sublingual doses of 100, 200, 300, 400 and 500 IR, Group 1 daily and Group 2 increments every second day. Repeated constant dose regimens of 300 IR and 500 IR were administered in Groups 3 and 4 respectively. Safety assessments included adverse events (AE), vital signs, electrocardiogram (ECG) and clinical laboratory tests. RESULTS: Sublingual immunotherapy 300 IR (Group 3) administered in a constant dose and incremental doses up to 500 IR (Groups 1 and 2) were generally well tolerated. The majority of AEs were mild to moderate, the most common being oral pruritus, throat irritation and swollen tongue. Severe local AEs (swelling of throat) were observed only for Group 4. No serious systemic AEs were reported. There were no relevant changes in clinical laboratory, vital signs and ECG data. CONCLUSION: Adverse events were mostly local (sublingual), were not severe and resolved rapidly. Using a 5-day induction regimen high-dose treatment up to 500 IR could be administered without important side-effects, in contrast to initiating with a constant dose of 500 IR. The data indicate that a short dose increase phase may reduce the incidence of AEs when high-dose SLIT is administered.

Administration, Sublingual↗
PubMed2004

Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy study.

BACKGROUND: Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed. OBJECTIVE: To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side-effects. METHODS: A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age. RESULTS: Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one-half and SCIT to one-third of placebo treatment. No statistical significant difference between the two groups was observed. Both for symptoms and medication scores actively treated patients showed statistically significant and clinical relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects. CONCLUSION: Based on the limited number of patients the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile SLIT may be favored.

Administration, Sublingual↗
PubMed2003

Retrospective assessment of seasonal allergic symptoms: over-rating but useful.

BACKGROUND: The history of the severity of seasonal allergic symptoms is often obtained post-seasonally as a retrospective assessment. Correct rating is essential when determining the efficacy of pharmaceutical treatment, indications for allergen-specific immunotherapy (SIT), or inclusion into controlled clinical studies. OBJECTIVES: To investigate the agreement between in- and post-seasonal ratings of seasonal symptoms, and to investigate whether the effect of SIT could be detected retrospectively. MATERIAL AND METHODS: Thirty-five birch pollen-allergic patients were allocated to SIT or placebo in a double-blind study. Assessment of severity of symptoms from the nose, eyes and lungs were performed daily during the season 2000, and post-seasonally 6 months after the season in 1999 and 2000. A four-point verbal descriptor scale (VDS-4) was used at all occasions. A mean in-seasonal symptom rating was calculated for four periods: the day, the week and the 2 weeks with the highest symptoms score, and the arithmetic season (the period covering the mid-90% of the accumulated pollen count). In- and post-seasonal ratings were compared with Cohen's weighted kappa (kappaw). RESULTS: Agreement between in-seasonal and retrospective ratings was fair to moderate (kappaw: 0.30-0.60). Post-seasonal ratings were most related to symptoms experienced in the week with the highest symptom scores, and least related to the arithmetic season. The post-seasonal ratings were significantly skewed towards higher symptom scores than the mean of in-seasonal ratings in periods >or= 2 weeks. Despite being comparable before intervention, only in the SIT-treated group was a significant decrease in post-season ratings of severity of rhinoconjunctivitis apparent (P < 0.05). Asthma scores were not reduced but fewer patients in the SIT group reported lung symptoms (P < 0.001). CONCLUSION: Post-seasonal assessment of seasonal allergic symptoms generally describes a shorter period than the arithmetic season. Post-season assessment tends to over-rate average symptom severity, but appears sufficiently sensitive to detect treatment efficacy.

Female↗
PubMed2003

Long-term repeatability of the skin prick test is high when supported by history or allergen-sensitivity tests: a prospective clinical study.

BACKGROUND: Long-term reproducibility of the skin-prick test (SPT) has been questioned. The aim of the study was to investigate the clinical relevance of SPT changes. METHODS: SPT to 10 common inhalation allergens was performed annually from 1999 to 2001 in 25 nonsensitized and 21 sensitized subjects. An SPT was positive when > or =3 mm, and repeatable if either persistently positive or negative. Clinical sensitivity to birch pollen was used as model for inhalation allergy, and was investigated at inclusion and at study termination by challenge tests, intradermal test, titrated SPT and IgE measurements. Birch pollen symptoms were confirmed in diaries. RESULTS: The repeatability of a positive SPT was 67%, increasing significantly to 100% when supported by the history. When not supported by history, the presence of specific IgE was significantly associated with a repeatable SPT. Allergen sensitivity was significantly lower in subjects loosing SPT positivity. The repeatability of a negative test was 95%, decreasing significantly to 87% by the presence of other sensitization. Development of a positive SPT was clinically relevant. Elevation of SPT cut-off point did not enhance repeatability. CONCLUSION: SPT changes are clinically relevant. Further studies using other allergens are needed. Long-term repeatability of SPT is high in the presence of a supportive history.

Adult↗
PubMed2002

The safety and efficacy of subcutaneous birch pollen immunotherapy - a one-year, randomised, double-blind, placebo-controlled study.

BACKGROUND: There is only very limited documentation of the efficacy and safety of high-dose subcutaneous birch pollen immunotherapy (IT) in double-blind, placebo-controlled (DBPC) studies. Birch pollen is a major cause of allergic morbidity in northern Europe and in eastern parts of North America. METHODS: Thirty-five patients with severe rhinoconjunctivitis (hay fever) to birch pollen were allocated to double-blinded clustered IT with a depot birch pollen extract (Betula verrucosa) or placebo injections. Seven patients in each group had concomitant self-reported seasonal asthma. Treatment was conducted as a clustered regimen and was performed in a specialist unit. Symptom scores from nose, eyes, and lungs, and use of oral and topical antihistamines, beta-2-agonists, and oral corticosteroids were recorded daily during the season of 2000. Sensitivity to allergen provocation in skin, conjunctiva, and nasal mucosa was measured before and after 10 months of treatment. Post-seasonal assessment of symptom severity was performed using a simple questionnaire. RESULTS: IT reduced the symptom score for both rhinoconjunctivitis and asthma (P-values < 0.05), total medication score (P < 0.02) and use of oral antihistamines (P < 0.01). IT reduced specific conjunctival sensitivity (P < 0.05), skin prick test, and especially cutaneous late-phase response diameters (P < 0.00001), and increased general well-being on post-seasonal evaluation (P < 0.01). IT was safe, with side-effects at the same level as placebo. CONCLUSIONS: High-dose, subcutaneous IT is efficacious and safe in patients with severe birch pollen rhinoconjunctivitis and asthma.

Adult↗