Patients with well-controlled chronic urticaria may halt omalizumab treatment

Key takeaways:

• 66% of patients remained treatment free for a year after halting treatment.
• 88.1% achieved equal or better effectiveness after treatment resumed.

Some patients who use omalizumab to treat their chronic urticaria may discontinue its use to reveal disease remission and avoid drug exposure, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.

However, patients who are older or who have fast initial response may need retreatment sooner than other patients, Michelle A.J. Meertens, MD, PhD candidate, Urticaria Centre of Excellence and Reference, department of dermatology/allergology, University Medical Center Utrecht, Utrecht University, and colleagues wrote.

The study involved 492 patients (mean age, 41 years; 71% female) with chronic urticaria treated with 300 mg of omalizumab (Xolair; Genentech, Novartis) every 4 weeks at University Medical Center Utrecht (UMCU) or Erasmus Medical Center (EMC) Rotterdam.

After three administrations at EMC Rotterdam and six administrations at UMCU, treatment intervals were gradually increased within 1 week for patients with well-controlled disease, defined as Urticaria Activity Scores (UAS) of 6 or lower or Urticaria Control Test (UCT) scores of 12 or higher.

Patients who were symptom free and had an 8-week treatment interval or insufficient response or side effects discontinued their treatment. If symptoms relapsed, patients could restart treatment with the steady-state interval — defined as the longest well-controlled treatment interval based on UCT or UAS scores achieved on at least two consecutive administrations — of the first treatment period, and this interval then was gradually prolonged.

Overall, 204 patients (41.5%) had continuous treatment. Also, 288 (58.5%) discontinued omalizumab after the first treatment period, with 116 of them (40.3%) restarting it with a median treatment-free period of 4.4 months (range, 1.8-54.5 months).

Treatment-free survival rates included 66% at 1 year, 58% at 2 years, 54% at 4 years and 52% at 7 years. Older age and fast initial treatment response, defined as UAS7 scores of 6 or lower or UCT scores of 12 or higher within 1 month of treatment, predicted shorter treatment-free periods.

There were no significant differences in good, partial or poor response rates between the two treatment episodes among the patients who restarted treatment, the researchers wrote.

Also, 88.1% of patients who restarted treatment achieved equal of better effectiveness during the second treatment episode. The patients with good or complete responses during the first treatment period included 90.1% who achieved good or complete responses during the second period. Eight patients (7.9%) had a worse response during the second period.

Mean steady-state treatment intervals included 7 weeks for the first treatment period and 8.1 weeks for the second period (P = .002), with 88.2% experiencing an equal or longer steady-state interval during the second period compared with the first.

Based on these findings, the researchers concluded that few patients need to restart treatment with omalizumab after a year without it.

Immunosenescence mechanisms may explain the role of higher age as an independent predictor for treatment, the researchers wrote, but this needs further investigation.

The researchers further noted that patients who have a fast response to treatment will quickly prolong their intervals before discontinuing treatment early, potentially leaving less time for “true” remission and prompting greater chances for relapse.

Among the patients who discontinued treatment due to well-controlled disease, median treatment durations included 12 months for patients who restarted treatment and 14 months for those who did not, indicating that patients with fast response may benefit from delaying any discontinuation in treatment.

The researchers additionally called omalizumab equally or more effective during a second treatment period, compared with a first period, in most patients who had equal or longer dosing intervals.

Overall, the researchers wrote, these findings are valuable for counseling patients in whether they should discontinue omalizumab in clinical practice.