PMID- 35014049 OWN - NLM STAT- MEDLINE DCOM- 20220603 LR - 20220623 IS - 1398-9995 (Electronic) IS - 0105-4538 (Linking) VI - 77 IP - 6 DP - 2022 Jun TI - Phase 2, randomized multi oral immunotherapy with omalizumab 'real life' study. PG - 1873-1884 LID - 10.1111/all.15217 [doi] AB - BACKGROUND: Oral immunotherapy (OIT) is frequently discontinued due to adverse events (AEs) and current data suggests that lowering OIT doses can minimize severity and frequency of AEs. However, the minimum daily dose that can enable desensitization and induce immune responses in multi-food OIT (mOIT) is unknown. METHODS: Participants aged 2-25 years with multi-food allergies were pretreated with fixed-dose omalizumab (150 mg, 3 doses, every 4 weeks), and randomized 1:1 to receive mOIT to a total maintenance dose of either 300 or 1200 mg total protein, (total dose includes at least two and up to a max of five allergens) and then transitioned to real-food protein equivalents after 18 weeks of treatment. The primary endpoint was the proportion of subjects with increases in IgG4/IgE ratio of at least 2 allergens by >/=25% from baseline after 18 weeks of therapy. The primary efficacy and safety analyses were done in the intention-to-treat population. RESULTS: Sixty participants were enrolled across two sites. Seventy percent of participants in both arms showed changes in sIgG4/sIgE ratio in at least 2 allergens with no difference between the treatment groups (OR [95% CI] = 1.00 [0.29, 3.49]). Overall, there were no differences in AEs between the 300 and 1200 mg groups (19% vs. 17%, p = .69), respectively. CONCLUSIONS: Our data suggest that plasma marker changes are induced early, even at a total protein dose of 300 mg inclusive of multiple allergens when mOIT is combined with fixed-dose omalizumab. Identification of optimal mOIT dosing with adjunct omalizumab is needed for the long-term success of OIT. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03181009). CI - (c) 2022 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. FAU - Sindher, Sayantani B AU - Sindher SB AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. AD - Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, California, USA. FAU - Kumar, Divya AU - Kumar D AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. AD - Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, California, USA. FAU - Cao, Shu AU - Cao S AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. AD - Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, California, USA. FAU - Purington, Natasha AU - Purington N AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. AD - Quantitative Sciences Unit, Stanford University, Stanford, California, USA. FAU - Long, Andrew AU - Long A AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. AD - Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, California, USA. FAU - Sampath, Vanitha AU - Sampath V AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. AD - Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, California, USA. FAU - Zedeck, Stacey S AU - Zedeck SS AD - University of California, Los Angeles, California, USA. AD - Department of Pediatrics, Division of Immunology, Allergy, and Rheumatology, Los Angeles, California, USA. FAU - Woch, Margaret A AU - Woch MA AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. FAU - Garcia-Lloret, Maria AU - Garcia-Lloret M AD - University of California, Los Angeles, California, USA. AD - Department of Pediatrics, Division of Immunology, Allergy, and Rheumatology, Los Angeles, California, USA. FAU - Chinthrajah, Rebecca Sharon AU - Chinthrajah RS AUID- ORCID: 0000-0003-2467-4256 AD - Sean N. Parker Center for Allergy and Asthma Research at Stanford University, Stanford, California, USA. AD - Division of Pulmonary and Critical Care Medicine, Stanford University, Stanford, California, USA. LA - eng SI - ClinicalTrials.gov/NCT03181009 GR - U19 AI104209/AI/NIAID NIH HHS/United States GR - R01 AI140134/AI/NIAID NIH HHS/United States GR - UM1 AI130839/AI/NIAID NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20220124 PL - Denmark TA - Allergy JT - Allergy JID - 7804028 RN - 0 (Allergens) RN - 0 (Immunologic Factors) RN - 2P471X1Z11 (Omalizumab) RN - 37341-29-0 (Immunoglobulin E) SB - IM MH - Administration, Oral MH - Allergens MH - *Desensitization, Immunologic/adverse effects MH - Humans MH - Immunoglobulin E MH - Immunologic Factors MH - *Omalizumab/adverse effects OTO - NOTNLM OT - IgE OT - IgG4 OT - maintenance dose OT - omalizumab OT - oral immunotherapy EDAT- 2022/01/12 06:00 MHDA- 2022/06/07 06:00 CRDT- 2022/01/11 07:02 PHST- 2021/12/17 00:00 [revised] PHST- 2021/10/13 00:00 [received] PHST- 2021/12/22 00:00 [accepted] PHST- 2022/01/12 06:00 [pubmed] PHST- 2022/06/07 06:00 [medline] PHST- 2022/01/11 07:02 [entrez] AID - 10.1111/all.15217 [doi] PST - ppublish SO - Allergy. 2022 Jun;77(6):1873-1884. doi: 10.1111/all.15217. Epub 2022 Jan 24.