There are currently no recommendations on withdrawal of omalizumab (OMA) in patients with severe allergic asthma. The current SPC states that discontinuation of treatment generally results in a return to elevated free IgE levels and associated symptoms.
The authors note that their open-label study is the first to report a step-down protocol in patients treated with omalizumab for severe asthma. The intervention consisted of the following: a) reduce OMA dose by half; b) if stable for six months then reduce by half again; c) administer oral corticosteroid boosters if needed; d) increase OMA dose if >1 booster needed and/or pulmonary function tests worsened.
Of the 35 analysed, 12 (34.3%) tolerated decreasing doses and then withdrawal. Among the remaining 23, 12 did not fulfil criteria for drug dose reduction, 3 did not tolerate the first reduction, 5 tolerated a dose reduction but not a withdrawal, and 3 required retreatment following withdrawal. Overall the protocol achieved a mean reduction of OMA consumption of 44.2%. No severe exacerbations related to the protocol were observed, nor any relevant side effects.