Retrospective case note review of chronic spontaneous urticaria outcomes and adverse effects in patients treated with omalizumab or ciclosporin in UK secondary care

Abstract

BackgroundOmalizumab is approved in the UK as add-on treatment for chronic spontaneous urticaria (CSU) in patients with inadequate response to H1-antihistamines. Ciclosporin is an established but unlicensed 3rd line option for CSU. Two parallel retrospective observational studies were conducted to describe outcomes of treatment and adverse events with omalizumab or ciclosporin for CSU treatment.MethodsData from UK specialist centres prescribing omalizumab (five centres) or ciclosporin (three centres) in CSU patients were collected from hospital records by clinical staff and pooled for analysis.ResultsForty-six patients prescribed omalizumab and 72 patients prescribed ciclosporin were included. Twenty-two (48%) omalizumab-treated patients had paired Urticaria Activity Scores (UAS7), showing a 25.4 point improvement during treatment (P < 0.0001). Paired Dermatology Life Quality Index (DLQI) was available in 28 (61%) omalizumab-treated and 17 (24%) ciclosporin-treated patients. At least a 75% improvement in DLQI score was observed in 79% of omalizumab-treated and 41% of ciclosporin-treated patients, and 65% of omalizumab-treated patients had complete resolution of their quality-of-life impairment (DLQI 0–1) versus 21% of ciclosporin-treated patients. Clinician comments reported symptom clearance in 15/36 (42%) omalizumab-treated and 10/60 (17%) ciclosporin-treated patients. Proportions of patients with adverse events were similar but those for omalizumab resembled CSU symptoms, making causality assignment difficult, whereas those for ciclosporin were consistent with its known adverse effect profile.ConclusionsValidated patient-reported measures of disease severity and quality of life should be used routinely in CSU management. Based on clinician comments and DLQI scores, symptoms and quality of life showed a greater improvement in the omalizumab-treated cohort than in the ciclosporin-treated cohort.

Omalizumab in the treatment of chronic spontaneous urticaria – literature review and own experience

“…[20] przeprowadzili retrospektywną analizę porównawczą pacjentów z pokrzywką przewlekłą nieodpowiadających na terapię lekami przeciwhistaminowymi leczonych omalizumabem i cyklosporyną. U pacjentów otrzymujących omalizumab stwierdzono istotnie większą poprawę jakości życia mierzoną jako redukacja wskaźnika wpływu dolegliwości skórnych na jakość życia (ang.…”

Urticaria and Angioedema Treatment

“…The most common adverse events associated with the use of CsA include hypertension, fatigue, gastrointestinal problems, and headache [15]. It is also thought that long-term use of CsA may be responsible for the development of non-melanoma skin cancer [16].…”

“…Cyclosporin has been reported to be efective in some studies of CSU, including three double-blind [12][13][14][15][16][17][18], and one study reported that 40% of patients achieved complete remission in 9 months [18].…”

Abordagem Diagnóstica e Terapêutica da Urticária Crónica Espontânea: Recomendações em Portugal

“…[2][3][4]16,171 Ainda assim, a razão risco/benefício tem mostrado ser bastante superior à utilização de corticóides a longo prazo. 1,138 Dado o expectável aumento de efeitos adversos com o tempo de utilização, alguns autores recomendam este tratamento apenas por três meses, 16 mas outros utilizam a ciclosporina em tratamentos mais longos, [139][140][141][142] havendo mesmo recomendações para tratamentos prolongados quando necessário. 143 As várias opções de recomendação descritas na literatura são: a) adição de ciclosporina a um anti-H1 de segunda geração, como opção de terceira linha, apenas em doentes com urticária grave e refratária a qualquer dose de anti-histamínicos 1 ; b) apenas utilizar ciclosporina A após falha de resposta ao omalizumab 16,17 ; ou c) considerar ciclosporina em baixa dose em doentes com urticária grave e refractária a anti-histamínicos.…”

“…52,155,156 Não existem comparações diretas entre o omalizumab e a ciclosporina, possivelmente dada a reconhecida dife-rença entre os perfis de segurança destes dois fármacos. No entanto, das três comparações indiretas encontradas, dois estudos concluem que o omalizumab é superior à ciclosporina em eficácia, 141,154 enquanto um conclui que a eficácia é semelhante, mas o perfil de segurança da ciclosporina é inferior.…”