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

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

Methods: Data 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.

Results: Forty-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.

Conclusions: Validated 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.
chronic spontaneous urticaria, ciclosporin, observational, omalizumab, retrospective
1710-1492
1-11
Savic, Sinisa
e105b0e4-5c39-43e6-8e8c-d80a07ad7faa
Marsland, Alexander
119756a5-39c7-4070-acda-fdead0b5beb1
McKay, David
ba1941a3-1784-4221-9cd6-cb9492e63981
Ardern-Jones, Michael R.
7ac43c24-94ab-4d19-ba69-afaa546bec90
Leslie, Tabi
cd8b5b60-b883-4ac2-b6a3-58c536ceb0a6
Somenzi, Olivier
5ba3a845-b429-4329-af64-5696dcc649ae
Baldock, Laura
9fefb823-2456-44af-9814-c6361f461bbf
Grattan, Clive
c41dbde9-63de-43f2-808e-d1cd5946a9e0
Savic, Sinisa
e105b0e4-5c39-43e6-8e8c-d80a07ad7faa
Marsland, Alexander
119756a5-39c7-4070-acda-fdead0b5beb1
McKay, David
ba1941a3-1784-4221-9cd6-cb9492e63981
Ardern-Jones, Michael R.
7ac43c24-94ab-4d19-ba69-afaa546bec90
Leslie, Tabi
cd8b5b60-b883-4ac2-b6a3-58c536ceb0a6
Somenzi, Olivier
5ba3a845-b429-4329-af64-5696dcc649ae
Baldock, Laura
9fefb823-2456-44af-9814-c6361f461bbf
Grattan, Clive
c41dbde9-63de-43f2-808e-d1cd5946a9e0

Savic, Sinisa, Marsland, Alexander, McKay, David, Ardern-Jones, Michael R., Leslie, Tabi, Somenzi, Olivier, Baldock, Laura and Grattan, Clive (2015) Retrospective case note review of chronic spontaneous urticaria outcomes and adverse effects in patients treated with omalizumab or ciclosporin in UK secondary care. Allergy Asthma & Clinical Immunology, 11 (21), 1-11. (doi:10.1186/s13223-015-0088-7). (PMID:26195984)

Record type: Article

Abstract

Background: Omalizumab 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.

Methods: Data 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.

Results: Forty-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.

Conclusions: Validated 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.

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More information

Accepted/In Press date: 23 June 2015
Published date: 21 July 2015
Keywords: chronic spontaneous urticaria, ciclosporin, observational, omalizumab, retrospective
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 390063
URI: https://eprints.soton.ac.uk/id/eprint/390063
ISSN: 1710-1492
PURE UUID: 9cce37e2-c03f-435d-8ad9-7b6094163398

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Date deposited: 17 Mar 2016 16:17
Last modified: 17 Jul 2017 19:31

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