scholarly journals Intralymphatic allergen administration renders specific immunotherapy faster and safer: A randomized controlled trial

2008 ◽  
Vol 105 (46) ◽  
pp. 17908-17912 ◽  
Author(s):  
Gabriela Senti ◽  
Bettina M. Prinz Vavricka ◽  
Iris Erdmann ◽  
Mella I. Diaz ◽  
Richard Markus ◽  
...  
Keyword(s):  
Specific Immunotherapy ◽  
Treatment Time ◽  
Controlled Trial ◽  
Skin Prick Testing ◽  
Pollen Extract ◽  
Open Label ◽  
Allergen Specific Immunotherapy ◽  
Safety And Efficacy ◽  
Nasal Provocation ◽  
Intralymphatic Immunotherapy

The only causative treatment for IgE-mediated allergies is allergen-specific immunotherapy. However, fewer than 5% of allergy patients receive immunotherapy because of its long duration and risk of allergic side effects. We aimed at enhancing s.c. immunotherapy by direct administration of allergen into s.c. lymph nodes. The objective was to evaluate safety and efficacy compared with conventional s.c. immunotherapy. In a monocentric open-label trial, 165 patients with grass pollen-induced rhinoconjunctivitis were randomized to receive either 54 s.c. injections with pollen extract over 3 years [cumulative allergen dose 4,031,540 standardized quality units (SQ-U)] or 3 intralymphatic injections over 2 months (cumulative allergen dose 3,000 SQ-U). Patients were evaluated after 4 months, 1 year, and 3 years by nasal provocation, skin prick testing, IgE measurements, and symptom scores. Three low-dose intralymphatic allergen administrations increased tolerance to nasal provocation with pollen already within 4 months (P < 0.001). Tolerance was long lasting and equivalent to that achievable after standard s.c. immunotherapy (P = 0.291 after 3 years). Intralymphatic immunotherapy ameliorated hay fever symptoms (P < 0.001), reduced skin prick test reactivity (P < 0.001), decreased specific serum IgE (P < 0.001), caused fewer adverse events than s.c. immunotherapy (P = 0.001), enhanced compliance (P < 0.001), and was less painful than venous puncture (P = 0.018). In conclusion, intralymphatic allergen administration enhanced safety and efficacy of immunotherapy and reduced treatment time from 3 years to 8 weeks.

Intralymphatic immunotherapy for allergic rhinitis: A systematic review and meta-analysis

2021 ◽  
Vol 42 (4) ◽  
pp. 283-292 ◽  
Author(s):  
Michael T. Werner ◽  
John V. Bosso
Keyword(s):  
Systematic Review ◽  
Allergic Rhinitis ◽  
Adverse Event ◽  
Skin Prick Testing ◽  
Meta Analysis ◽  
Mean Difference ◽  
Random Effects Model ◽  
Nasal Provocation ◽  
Intralymphatic Immunotherapy ◽  
Standardized Mean Difference

Background: Only a fraction of patients with allergic rhinitis receive allergen-specific immunotherapy (AIT). AIT is most commonly delivered subcutaneously in a series of injections over 3‐5 years. Common obstacles to completing this therapy include cost and inconvenience. Intralymphatic immunotherapy (ILIT) has been proposed as a faster alternative, which requires as few as three injections spaced 4 weeks apart. Objective: This systematic review and meta-analysis evaluated the current evidence that supports the use of ILIT for allergic rhinitis. Methods: Clinical trials were identified in the published literature by using an electronic search strategy and were evaluated by using a risk of bias tool. Treatment outcome (symptom scores, medication scores, and combined symptom and medication scores) and provocation testing results (nasal provocation and skin-prick testing) were included in a meta-analysis of standardized mean difference with subgrouping by using a random-effects model. Overall adverse event rates were tabulated, and overall risk ratios were calculated by using a random-effects model. Results: We identified 17 clinical trials that met eligibility criteria. The standardized mean difference of ILIT on the symptom and medication score was ‐0.72 (95% confidence interval [CI], ‐0.98 to ‐0.46; p < 0.0001) (n = 10). The standardized mean difference of ILIT on nasal provocation and skin-prick testing was ‐1.00 (95% CI, ‐1.38 to ‐0.61; p < 0.0001) (n = 7) and ‐0.73 (95% CI, ‐0.99 to ‐0.47; p < 0.0001) (n = 7), respectively. No statistically significant heterogeneity was detected. The overall adverse event rate was 39.5% for ILIT and 23.5% for placebo. Also, 98.4% of adverse events were mild. Conclusion: Our meta-analysis demonstrated that ILIT was safe, conferred desensitization to seasonal and nonseasonal allergens, alleviated allergic rhinitis symptoms, and reduced medication use. A larger randomized, double-blind, placebo controlled trial will be necessary for wider adaptation of this form of AIT.

A randomized, phase I/II trial of AMG 102 or AMG 479 in combination with panitumumab (pmab) compared with pmab alone in patients (pts) with wild-type (WT) KRAS metastatic colorectal cancer (mCRC): Safety and efficacy results.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 366-366 ◽  
Author(s):  
E. Van Cutsem ◽  
C. Eng ◽  
J. Tabernero ◽  
E. Nowara ◽  
A. Swieboda-Sadlej ◽  
...  
Keyword(s):  
Growth Factor ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Objective Response ◽  
Growth Factor Receptor ◽  
Capillary Leak Syndrome ◽  
Capillary Leak ◽  
Open Label ◽  
Human Mabs ◽  
Safety And Efficacy

366 Background: Pmab is a fully human anti-epidermal growth factor receptor monoclonal antibody (mAb) approved as monotherapy for pts with mCRC. AMG 102 and AMG 479 are investigational, fully human mAbs against hepatocyte growth factor (HGF) and insulin-like growth factor receptor 1 (IGF1R), respectively. This 3-part study evaluated the safety and efficacy of AMG 102 or AMG 479 in combination with pmab. Methods: Part 1 was a phase 1b, open-label, dose-finding study to determine a tolerable dose of AMG 102 in combination with pmab. Part 2 was a phase II, randomized, blinded, placebo-controlled trial that explored pmab + the dose of AMG 102 selected in Part 1 vs pmab + AMG 479 vs pmab + placebo. Part 3 is a 2-arm randomized extension study for pts who developed disease progression (PD) or intolerability to pmab + placebo in part 2. Eligible pts were ≥ 18 years old with WT KRAS mCRC and ECOG PS 0/1. In part 1, all pts received 6 mg/kg pmab + 10 mg/kg AMG 102 Q2W IV until PD or intolerability. The primary endpoint of part 1 was the incidence of dose-limiting toxicities (DLTs). The primary endpoint for part 2 is objective response rate (ORR). Results: In part 1, no DLTs were reported for the first 6 DLT-evaluable pts. A total of 11 pts were enrolled in part 1 prior to the decision to use the 10 mg/kg Q2W AMG 102 dose in part 2; 5 pts were men; mean (range) age was 56 (37-75) yrs; ECOG 0/1 was 55%/45%. Grade 3 treatment-related adverse events (AEs) were acneiform dermatitis or rash (55%), paronychia (18%), infection (9%), capillary leak syndrome (9%), erythema (9%), nail disorder (9%), and pruritus (9%). There were no grade 4 or 5 treatment-related AEs. Serious AEs included acneiform dermatitis (n = 1), intestinal obstruction (n = 1), cerebrovascular accident (n = 1), capillary leak syndrome (n = 1), and anemia/general health deterioration (n = 1). One pt died on study from PD. In part 2, 142 pts received at least one dose of study drug; enrollment is complete, and data analyses are ongoing. Conclusions: In part 1, 6 mg/kg pmab + 10 mg/kg AMG 102 Q2W was well tolerated. Primary efficacy results from part 2, including ORR and progression-free survival, will be presented. [Table: see text]

scholarly journals Adjunctive Vitamin D2 Supplement in Patient with Allergen-Specific Immunotherapy Randomized, Double Blind, Placebo-Controlled Trial

2020 ◽  
Vol 145 (2) ◽  
pp. AB60
Author(s):  
Chirawat Chiewchalermsri ◽  
Sasipa Sangkanjanavanich ◽  
Panitan Pradubpongsa ◽  
Wat Mitthamsiri ◽  
Nattapon Jaisupa ◽  
...  
Keyword(s):  
Specific Immunotherapy ◽  
Controlled Trial ◽  
Vitamin D2 ◽  
Double Blind ◽  
Allergen Specific Immunotherapy ◽  
Double Blind Placebo
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