Aidan Long1, Abdelkader Rahmaoui2, Kenneth J Rothman3, Eva Guinan4, Mark Eisner2, Mary S Bradley2, Carlos Iribarren5, Hubert Chen2, Gillis Carrigan2, Karin Rosén2, Stanley J Szefler6. 1. Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, and Harvard Medical School, Cambridge, Mass. Electronic address: aalong@mgh.harvard.edu. 2. Genentech, South San Francisco, Calif. 3. RTI Health Solutions, Research Triangle Park, NC. 4. Dana-Farber Cancer Institute, Boston, Mass. 5. Division of Research, Kaiser Permanente Medical Care Program, Oakland, Calif. 6. Children's Hospital Colorado and University of Colorado Denver School of Medicine, Denver, Colo.
Abstract
BACKGROUND: The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) assessed the long-term safety of omalizumab in a clinical practice setting as part of a phase IV US Food and Drug Administration postmarketing commitment. OBJECTIVE: We sought to evaluate long-term safety in omalizumab-treated and nonomalizumab-treated patients. Primary outcome measures focused on assessment of malignancies. METHODS: EXCELS was a prospective observational cohort study in patients (≥12 years of age) with moderate-to-severe allergic asthma. There were 2 cohorts: omalizumab (taking omalizumab at baseline) and nonomalizumab (no history of omalizumab treatment). Primary outcomes included all confirmed, incident, study-emergent primary malignancies (malignancies), including and excluding nonmelanoma skin cancer (NMSC); all malignancies were externally adjudicated. RESULTS: The omalizumab cohort had a higher proportion of patients with severe asthma compared with the nonomalizumab cohort (50.0% vs 23.0%). Median follow-up was approximately 5 years for both cohorts. Crude malignancy rates were similar in the omalizumab and nonomalizumab cohorts, with a rate ratio of 0.84 (95% CI, 0.62-1.13) for all malignancies and 0.98 (95% CI, 0.71-1.36) for all malignancies excluding NMSC. Kaplan-Meier plots of time to first confirmed study-emergent primary malignancy were similar for the 2 treatment cohorts. Cox proportional hazards modeling, adjusting for confounders and risk factors, resulted in a hazard ratio (omalizumab vs nonomalizumab) of 1.09 (95% CI, 0.87-1.38) for all malignancies and 1.15 (95% CI, 0.83-1.59) for all malignancies excluding NMSC. CONCLUSION: Results from EXCELS suggest that omalizumab therapy is not associated with an increased risk of malignancy.
BACKGROUND: The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) assessed the long-term safety of omalizumab in a clinical practice setting as part of a phase IV US Food and Drug Administration postmarketing commitment. OBJECTIVE: We sought to evaluate long-term safety in omalizumab-treated and nonomalizumab-treated patients. Primary outcome measures focused on assessment of malignancies. METHODS: EXCELS was a prospective observational cohort study in patients (≥12 years of age) with moderate-to-severe allergic asthma. There were 2 cohorts: omalizumab (taking omalizumab at baseline) and nonomalizumab (no history of omalizumab treatment). Primary outcomes included all confirmed, incident, study-emergent primary malignancies (malignancies), including and excluding nonmelanoma skin cancer (NMSC); all malignancies were externally adjudicated. RESULTS: The omalizumab cohort had a higher proportion of patients with severe asthma compared with the nonomalizumab cohort (50.0% vs 23.0%). Median follow-up was approximately 5 years for both cohorts. Crude malignancy rates were similar in the omalizumab and nonomalizumab cohorts, with a rate ratio of 0.84 (95% CI, 0.62-1.13) for all malignancies and 0.98 (95% CI, 0.71-1.36) for all malignancies excluding NMSC. Kaplan-Meier plots of time to first confirmed study-emergent primary malignancy were similar for the 2 treatment cohorts. Cox proportional hazards modeling, adjusting for confounders and risk factors, resulted in a hazard ratio (omalizumab vs nonomalizumab) of 1.09 (95% CI, 0.87-1.38) for all malignancies and 1.15 (95% CI, 0.83-1.59) for all malignancies excluding NMSC. CONCLUSION: Results from EXCELS suggest that omalizumab therapy is not associated with an increased risk of malignancy.
Authors: Marek L Kowalski; Ignacio Ansotegui; Werner Aberer; Mona Al-Ahmad; Mubeccel Akdis; Barbara K Ballmer-Weber; Kirsten Beyer; Miguel Blanca; Simon Brown; Chaweewan Bunnag; Arnaldo Capriles Hulett; Mariana Castells; Hiok Hee Chng; Frederic De Blay; Motohiro Ebisawa; Stanley Fineman; David B K Golden; Tari Haahtela; Michael Kaliner; Connie Katelaris; Bee Wah Lee; Joanna Makowska; Ulrich Muller; Joaquim Mullol; John Oppenheimer; Hae-Sim Park; James Parkerson; Giovanni Passalacqua; Ruby Pawankar; Harald Renz; Franziska Rueff; Mario Sanchez-Borges; Joaquin Sastre; Glenis Scadding; Scott Sicherer; Pongsakorn Tantilipikorn; James Tracy; Vera van Kempen; Barbara Bohle; G Walter Canonica; Luis Caraballo; Maximiliano Gomez; Komei Ito; Erika Jensen-Jarolim; Mark Larche; Giovanni Melioli; Lars K Poulsen; Rudolf Valenta; Torsten Zuberbier Journal: World Allergy Organ J Date: 2016-10-12 Impact factor: 4.084
Authors: Leslie Hendeles; Yasmeen R Khan; Jonathan J Shuster; Sarah E Chesrown; Mutasim Abu-Hasan Journal: Ann Allergy Asthma Immunol Date: 2015-01 Impact factor: 6.347