A retrospective analysis omalizumab treatment patterns in patients with chronic spontaneous urticaria: a real‐world study in Belgium

Abstract

Background Chronic spontaneous urticaria (CSU) is characterized by the repeated occurrence of persistent hives and/or angioedema for ≥6 weeks, without specific external stimuli. H 1-antihistamines have long been the standard of care of CSU, but many patients remain uncontrolled even at 49 the approved dose. Add-on therapy with omalizumab has proven effective in clinical trials, but little is known about omalizumab treatment in Belgium. Objective To collect real-world clinical data on omalizumab treatment in adults with CSU in Belgium. Methods This was an observational, retrospective chart review of adults with CSU, who initiated omalizumab treatment between August 2014 and December 2016 (maximum 28 months follow-up). Results In total, 235 patients were included (median time from symptom onset to diagnosis, 5.4 months; median time from diagnosis to commencing omalizumab, 6.7 months). Treatments used before/after commencing omalizumab did not always adhere to guidelines; many patients (26.4%/11.1%) received first-generation H 1-antihistamines, while 20.4% used omalizumab monotherapy after initiating treatment. The mean interval between omalizumab administrations was 4.8 (SD 1.7) weeks; 67.8% of patients had ≥1 interval prolongation and/or shortening. Mean baseline 7-day Urticaria Activity Score (UAS7) was 32.0 (SD 6.05); this improved to 12.6 (SD 11.2) after 1 month of omalizumab. About 67.2% of patients reached UAS7 ≤ 6 (well controlled) during the study. A total of 87 patients stopped omalizumab and never restarted before the end of the observation period; the most prevalent reason was remission of symptoms (49.4% of patients), followed by lack of effect (12.6%), lost to follow-up (6.9%) and adverse events (3.4%). Headache was the most common adverse event (n = 8/82). No anaphylaxis was reported. Conclusions This study revealed that patients initiated on omalizumab in Belgium had severe CSU at baseline, and showed substantial improvements after 1 month of treatment. Greater adherence to the prescription of guideline-recommended medications is needed for the treatment of CSU.

High‐dose non‐sedating antihistamines are used insufficiently in chronic urticaria patients treated with omalizumab

“…27 A later study using retrospective chart review demonstrated, that 20.4% of patients received omalizumab monotherapy without any nsAH1. 28 Low adherence to prescribed treatment has been widely reported in patients with chronic diseases. 29 In questionnaires among…”

“…So, reasons for insufficient nsAH1 dosing might be dual. Both that, the doctors are not adherent to the guideline-recommended treatments 27,28 and patients are not adherent to the prescribed medication. 29,30 Thus, it is important to be aware of sub-standard adherence in CU patients.…”

Analysis of the long‐term economic burden of omalizumab on patients with chronic spontaneous urticaria

“…Likewise, a previous study showed that 17% of patients with CSU were treated with cyclosporin before OMA while only 7% were still on cyclosporin in combination after initiating OMA. 21 Nevertheless, at the 6th month and later after starting OMA, the decrease in drug cost in the pretreatment step 4-5 group was not as much as that observed in the pretreatment step 1-3 group, because five (29%) of the 17 patients still continued OMA without dose reduction or interval extension. Thus, OMA is required to be continued in severe cases treated with step 4 or 5 treatment prior to OMA, but the reduction of immunosuppressants following relief of urticarial symptom by OMA can be achieved and thereby reduce patients' economic burden.…”

“…Therefore, the reduction of the drug costs at the 3rd month after the introduction of OMA partially depends on the dose reduction of expensive immunosuppressive medicines. Likewise, a previous study showed that 17% of patients with CSU were treated with cyclosporin before OMA while only 7% were still on cyclosporin in combination after initiating OMA 21 . Nevertheless, at the 6th month and later after starting OMA, the decrease in drug cost in the pretreatment step 4–5 group was not as much as that observed in the pretreatment step 1–3 group, because five (29%) of the 17 patients still continued OMA without dose reduction or interval extension.…”

Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress

“…Although omalizumab is approved and recommended by the guidelines as an add-on therapy to AHs as third-line treatment, up to 20% of the patients discontinue AHs and use omalizumab as monotherapy [1,64]. Despite some evidence indicating that omalizumab monotherapy is as effective as combined use with AHs, future studies are needed on the use of omalizumab as monotherapy [62].…”