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Omalizumab Response Profile and Management

J Investig Allergol Clin Immunol 2019; Vol. 29(5): 338-348

© 2019 Esmon Publicidad

doi: 10.18176/jiaci.0323

initiation of treatment—our recommendation is to re-evaluate

the patient after 6 months on omalizumab [45]. However, if

the nonresponder shows symptoms of intolerance, therapy

may be changed after 3 months of omalizumab instead of

6 months.

In nonresponders, there are 2 possible therapeutic

strategies: increasing the omalizumab dose while maintaining

the same treatment interval; and reducing the treatment interval

while maintaining the original dose. The strategy selected will

depend on the patient's weekly UAS7 scores over the 4-week

period. Thus, if the UAS7 score remains >16 at all weekly

assessments, then the dose should be increased. However, if

the score is >16 only during 2 weeks after administration, then

the treatment interval should be reduced.

In cases in which the therapeutic strategy is modified, it is

advisable to re-evaluate the patient 3 months after changing the

strategy; if the response does not improve, then we recommend

withdrawing omalizumab and performing another medical

evaluation to reassess the treatment approach.

4.2. Partial Responders

A partial responder to omalizumab is defined a patient

whose UAS7 score partially improves over baseline but who

maintains a UAS7 score of 7-15 (Table 2). In patients who

demonstrate a partial response to the standard omalizumab

dose, we recommend waiting 6 months before altering the

treatment plan, although this will depend on the patient's

symptoms or level of discomfort. If the UAS7 scores remain in

the 7-15–point range after 6 months of standard treatment, we

recommend modifying the regimen. As with nonresponders,

the recommended modification is to either increase the dose

while maintaining the same treatment interval or, conversely,

to shorten the interval from 4 to 2 weeks while maintaining the

original dose. The patient should be re-evaluated after 3months,

and if disease control remains poor, we suggest withdrawing

omalizumab and reassessing the patient. However, it is important

to consider the patient’s opinion with regard to the efficacy of

the drug before deciding to discontinue treatment.

344

Figure 3.

Therapeutic algorithm for the 4 different omalizumab response profiles.

Anti-H

1

(2

nd

generation)

Withdraw omalizumab

and re-evaluation

No response

No response

Worsening?

Worsening?

Review 3 mo

Review 3 mo

Review 3-6 mo** 6 mo

Review 3-6 mo**

3-6 mo

3-6 mo

Review 4 wk

Review 3 and 6 mo*

Review 2-4 wk

2

nd

generation anti-H

1

dose

Omalizumab (300 mg/4 wk)

Withdraw omalizumab

and re-evaluation

Back to dose

300 mg/4wk

Back to dose

300 mg/4wk

Patient re-evaluation

Patient re-evaluation

Dose

= Frequency

Dose

= Frequency

Dose

= Frequency

= Dose

= Frequency

Patient

re-evaluation

Dose

= Frequency

Frequency

= Dose

Frequency

= Dose

Frequency

= Dose

Frequency

= Dose

Nonresponder

UAS7 >16

Partial responder

UAS7= 7-15

Good responder

UAS7= 1-6

Complete responder

UAS7= 0

Short corticosteroid cycles are permitted in exacerbations

*Continue omalizumab up to 6 months, except in nonresponders with intolerable signs and symptoms, and in complete responders, in whom the

therapeutic strategy could be adapted 3 months after initiation of omalizumab.

**In those cases in which a sustained response is achieved for ≥8 weeks, omalizumab can be discontinued to evaluate whether the patient continues

in remission.