PMID- 24028677 OWN - NLM STAT- MEDLINE DCOM- 20140829 LR - 20151119 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 30 IP - 1 DP - 2014 Jan TI - Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma. PG - 59-66 LID - 10.1185/03007995.2013.844115 [doi] AB - BACKGROUND: Omalizumab, a humanised anti-immunoglobulin E monoclonal antibody for treatment of uncontrolled moderate-to-severe or severe persistent allergic asthma, was developed as a lyophilised powder for reconstitution. A liquid formulation in pre-filled syringes has now been developed. The purpose of this study was to assess the immunogenicity and safety of this liquid formulation. METHODS: In this multinational, open-label, single-arm study, patients (>/=12 years) with moderate-to-severe allergic asthma were treated for 24 weeks with the liquid formulation of omalizumab (75 or 150 mg in a pre-filled syringe) at 2 or 4 week intervals. Immunogenicity was assessed by measurement of human anti-therapeutic antibody (ATA) levels. Safety was assessed by monitoring adverse events (AEs), haematology, blood chemistry, urine analysis and vital signs. RESULTS: A total of 155 patients were enrolled in the study. No patient had a confirmed positive ATA test result. Most frequent individual AEs were asthma (17.4%), sinusitis (17.4%) and upper respiratory tract infection (11.6%). Fourteen patients (9.0%) had serious AEs and there was one death (not treatment related). There were no cases of anaphylaxis according to Sampson criteria. Most patients remained within normal ranges for haematology and biochemistry laboratory variables. CONCLUSIONS: Omalizumab in pre-filled syringes was not associated with immunogenicity. This novel formulation, which does not require reconstitution, had a safety profile consistent with the lyophilised formulation. A limitation of this study is that efficacy of omalizumab in the treatment of asthma was not specifically addressed herein. Clinicaltrials.gov identifier: NCT00500539. FAU - Somerville, Laura AU - Somerville L AD - Houston Allergy & Asthma Associates , Baytown, TX , USA. FAU - Bardelas, Jose AU - Bardelas J FAU - Viegas, Andrea AU - Viegas A FAU - D'Andrea, Peter AU - D'Andrea P FAU - Blogg, Martin AU - Blogg M FAU - Peachey, Guy AU - Peachey G LA - eng SI - ClinicalTrials.gov/NCT00500539 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20131001 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Anti-Allergic Agents) RN - 0 (Anti-Asthmatic Agents) RN - 0 (Antibodies, Anti-Idiotypic) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (anti-IgE antibodies) RN - 2P471X1Z11 (Omalizumab) RN - 37341-29-0 (Immunoglobulin E) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Anti-Allergic Agents/administration & dosage/adverse effects/immunology/*therapeutic use MH - Anti-Asthmatic Agents/administration & dosage/adverse effects/immunology/*therapeutic use MH - Antibodies, Anti-Idiotypic/administration & dosage/adverse effects/immunology/*therapeutic use MH - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects/immunology/*therapeutic use MH - Asthma/*drug therapy MH - Drug Delivery Systems/instrumentation MH - Female MH - Humans MH - Immunoglobulin E/immunology MH - Injections, Subcutaneous/adverse effects MH - Male MH - Middle Aged MH - Omalizumab MH - Respiratory Tract Infections MH - Sinusitis MH - Syringes MH - Treatment Outcome MH - Young Adult EDAT- 2013/09/14 06:00 MHDA- 2014/08/30 06:00 CRDT- 2013/09/14 06:00 PHST- 2013/09/14 06:00 [entrez] PHST- 2013/09/14 06:00 [pubmed] PHST- 2014/08/30 06:00 [medline] AID - 10.1185/03007995.2013.844115 [doi] PST - ppublish SO - Curr Med Res Opin. 2014 Jan;30(1):59-66. doi: 10.1185/03007995.2013.844115. Epub 2013 Oct 1.