Exacerbation rates and forced expiration volume (FEV1) improvements with omalizumab treatment were similar irrespective of comorbidity burden, according to a study published in Annals of Allergy, Asthma & Immunology.

Prior studies, according to the team that conducted the study, suggest a shared underlying inflammatory pathophysiological mechanism among asthma and comorbid conditions like gastroesophageal reflux disease, allergic rhinitis, nasal polyps, urticaria, atopic dermatitis, and food allergy. Multimorbid asthma, the presence of one or more comorbid conditions, is further associated with an IgE-polysensitized phenotype, which is accompanied by high allergen-specific IgE, high total IgE, and type 2 inflammation.


Response to Omalizumab With or Without Comorbidities Was Unknown

“Omalizumab, an anti-IgE antibody, has been found to have efficacy in reducing asthma exacerbations and improving asthma control in patients with moderate-to-severe allergic asthma in large randomized controlled trials and real-world observational studies,” the study authors write. “However, the response to omalizumab in patients with or without asthma-related or allergic comorbidities has not been previously evaluated.”

The study team conducted post hoc exploratory analyses using data from key placebo-controlled (008/009, INNOVATE, EXTRA) and real-world (PROSPERO) omalizumab studies to investigate the impact of comorbidity burden and type on asthma treatment outcomes with omalizumab in patients with allergic asthma. They examined response to omalizumab in patients with moderate-to-severe allergic asthma by asthma-related and allergic comorbidities. Patients aged 12 and older from placebo-controlled 008/009 (n = 1,071), EXTRA (n = 848), and INNOVATE (n = 419), and single-armed PROSPERO (n = 801) omalizumab studies were included. Poisson regression/analysis of covariance models was used to estimate adjusted exacerbation rates and FEV1 change from baseline after omalizumab initiation for subgroups by number of comorbidities (0, 1 [008/009]; 0, 1, ≥2 [EXTRA and INNOVATE]; 0, 1, 2, ≥3 [PROSPERO]).

In the EXTRA and INNOVATE studies, the researchers observed no consistent pattern for placebo-corrected relative rate reduction in normalized asthma exacerbations among omalizumab-treated comorbidity subgroups. In PROSPERO, they found that on-study exacerbation rates in the comorbidity subgroups were similar (0, 0.68; 1, 0.70; 2, 0.77; ≥3, 0.80). FEV1 improvements were observed throughout the study for omalizumab versus placebo for all comorbidity subgroups. “There were no consistent differences in FEV1 improvements among comorbidity subgroups in 008/009, EXTRA, or INNOVATE,” the study’s authors write. “Similarly, no among-group differences were observed for FEV1 change from baseline at month 12 in PROSPERO (0, 0.05 L; 1, 0.08 L; 2, 0.00 L; ≥3, 0.04 L).”