Omalizumab Improves Outcomes in Allergic Asthma Even With Off-Label Dosing

Allergic Asthma Inhaler Outdoors
Allergic Asthma Inhaler Outdoors
Can patients with allergic asthma benefit from omalizumab even if they fall outside the criteria put forth in the approved recommended dosing table?

Patients with allergic asthma who initiate omalizumab (OMA) experience similar reductions in exacerbations and hospitalizations regardless of whether or not they fall within the criteria of the approved recommended dosing schedule, according to study results presented at the American College of Chest Physicians (CHEST) 2022 Annual Meeting, held from October 16 to 19, 2022, in Nashville, Tennessee.

Many patients treated with omalizumab, an anti-IgE antibody approved for patients with moderate-severe allergic asthma, fall outside the approved recommended dosing schedule, which is determined by a patient’s body weight and pretreatment serum IgE levels. Researchers therefore examined exacerbation and hospitalization rates of US patients using omalizumab for allergic asthma who fell outside of the approved dosing schedule.

The investigators conducted a post hoc analysis of the PROSPERO study, a prospective, real-world, 48-week multicenter study of 801 patients aged 12 years and older with allergic asthma who started OMA a physician determined that they needed it. Investigators categorized participants into 3 subgroups:

  • Group 1: those who fell into the guidelines of the recommended dosing table (n=506);
  • Group 2: those for whom, according to the approved dosing table, insufficient clinical data was available to make dose recommendations (n=72); or
  • Group 3: those who did not meet criteria for groups 1 or 2 and had immunoglobulin E [IgE] less than 30 IU/mL or greater than 700 IU/mL, and/or weighed less than 30 kg or more than 150 kg (n=209).

Patient demographics were comparable among the 3 groups, except for total IgE (mean [SD], 182.8 [139.0] IU/mL in group 1; 481.5 [113.4] IU/mL in group 2; and 1579.8 [5022.3] IU/mL in group 3).

For each group, rates of exacerbations and hospitalizations were determined for the 12 months preceding OMA initiation and for the 12 months after OMA initiation. The 3 groups had a similar mean number of exacerbations in the 12 months preceding OMA initiation. In the 12 months after initiation, the mean number of exacerbations was reduced to a similar extent for patients in groups 1, 2, and 3 (exacerbation rate 12 months before initiation, 12 months after: 3.01, 0.73, P <.0001 in group 1; 3.07, 0.80, P <.0001 in group 2; and 3.06, 0.91, P <.0001 in group 3).

The mean number of hospitalizations was similar among all 3 groups in the 12 months before OMA initiation. Likewise, in the 12 months after OMA initiation, the mean number of hospitalizations was decreased in patients in all 3 groups (hospitalization rate 12 months before initiation, 12 months after initiation: 0.50, 0.07, P <.0001 in group 1; 0.53, 0.01, P =.0066 in group 2; and 0.56, 0.05, P =.0008).

The investigators concluded that “Asthma outcomes following OMA treatment may be similar in a wide range of patients with allergic asthma.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Hanania NA, Littlejohn M, Seetasith A, et al. Reductions in exacerbations and hospitalizations are similar across different omalizumab dosing regimens. Abstract presented at: CHEST 2022 Annual Meeting; October 16-19, 2022; Nashville, TN.

This article originally appeared on Pulmonology Advisor