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Clinical Trial
. 2018 Feb;84(2):339-348.
doi: 10.1111/bcp.13453. Epub 2017 Dec 1.

A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients

Christian Domingo  1   2 , Xavier Pomares  1   2   3 , Albert Navarro  4 , María José Amengual  5 , Concepción Montón  1   6 , Ana Sogo  1 , Rosa M Mirapeix  7
Affiliations
Clinical Trial

A step-down protocol for omalizumab treatment in oral corticosteroid-dependent allergic asthma patients

Christian Domingo et al. Br J Clin Pharmacol. 2018 Feb.

Abstract

Aims: There are no specific criteria for a step-down or withdrawal dose of omalizumab (OMA). Our purpose was to evaluate the viability of a protocol for OMAlizumab DOse REduction (the OMADORE study) in severe allergic asthma (SAA).

Methods: The study population included 35 SAA patients treated during a minimum period of 1 year with oral corticosteroids (OC) equivalent to a mean daily dose of 4 mg of methyl-prednisolone. To qualify for the protocol, the patients had to have received treatment with OMA for at least one and a half years, OC dose had to have reached the lowest tolerated dose and spirometry had to be greater than or equal to that at entry. The interventions were (a) OMA dose was reduced by half; (b) if patients were clinically stable after 6 months, the dose was halved again; (c) if repeated OC boosters were needed and/or spirometry worsened by more than 10%, OMA dose was raised to the previous figure until stabilization.

Results: Mean age was 52.5 (17) years, median monthly OC dose was 120 (IQR: 225) mg. Pulmonary function: FVC: 79.7 (20.2)%; FEV1 : 64.8 (21.7)%; FEV1 / FVC: 61.7(13.8)%. OMA could be withdrawn in 34.3% of the patients; 22.9% tolerated a reduction, and in 42.9% the dose could not be modified. Follow-up time after reduction or withdrawal ranged from 12 to 30 months. There were no severe exacerbations requiring emergency assistance or admission.

Conclusions: The OMADORE study found that in more than 50% of SAA patients on OC, OMA dose can be safely reduced or withdrawn based on a progressive dose reduction protocol.

Keywords: omalizumab; omalizumab withdrawal; severe allergic asthma; treatment step-down.

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Figures

Figure 1
Figure 1
OMA dose reduction protocol. *In the case of loss of asthma control (need for OC boosters and/or PFT worsening ≥10%) return to the previous STEP
Figure 2
Figure 2
Flowchart. Number of patients considered tolerant: 12/35 = 34.3%; partially tolerant: 5 + 3/35 = 22.9%; intolerant: 12 + 3/35 = 42.9%
Figure 3
Figure 3
Time‐sequence withdrawal of OMA according to the protocol. The x‐axis shows the number of patients treated with OMA at that stage. Note that the first withdrawal occurred at month 18, and thus appears on the x‐axis in the following month
Figure 4
Figure 4
Corticosteroid consumption according to protocol and group. (A) Mean OC consumption for every group. (B) Different ranges of cumulative OC dose of every group
Figure 5
Figure 5
Forced spirometry evolution. (A) and (B) FVC values in litres and percentages. (C) and (D) FEV1 values in litres and percentages
Figure 6
Figure 6
Th2 response markers at entry, month 6 and end. (A) and (B) Eosinophil values. (C) FeNO values. (D) IgE concentrations. Eos: eosinophils (overall count and in percentage); FeNO: fraction exhaled of nitric oxide (ppb); IgE: immunoglobulin E. The end measurement represents the date OMA was withdrawn and is therefore not uniform for the whole cohort
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