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Clinical response and long-term follow-up of 20 patients with refractory solar urticaria under treatment with omalizumab

2019; Elsevier BV; Volume: 88; Issue: 5 Linguagem: Inglês

10.1016/j.jaad.2019.05.070

1097-6787

D. Morgado‐Carrasco, Macarena Giácaman‐von der Weth, X. Fustà‐Novell, Sebastián Podlipnik, A. Pérez‐Ferriols, Paula Aguilera,

Mast cells and histamine

To the Editor: Treatment of solar urticaria (SU) is challenging.1Snast I. Kremer N. Lapidoth M. et al.Omalizumab for the treatment of solar urticaria: case series and systematic review of the literature.J Allergy Clin Immunol Pract. 2018; 6: 1198-1204.e3Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar One small clinical trial2Aubin F. Avenel-Audran M. Jeanmougin M. et al.Omalizumab in patients with severe and refractory solar urticaria: a phase II multicentric study.J Am Acad Dermatol. 2016; 74: 574-575Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar and a couple of case series1Snast I. Kremer N. Lapidoth M. et al.Omalizumab for the treatment of solar urticaria: case series and systematic review of the literature.J Allergy Clin Immunol Pract. 2018; 6: 1198-1204.e3Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar, 3Morgado-Carrasco D. Fustà-Novell X. Podlipnik S. Combalia A. Aguilera P. Clinical and photobiological response in eight patients with solar urticaria under treatment with omalizumab, and review of the literature.Photodermatol Photoimmunol Photomed. 2018; 34: 194-199Crossref Scopus (12) Google Scholar report variable outcomes with the anti-IgE omalizumab, and there is a lack of long-term follow-up. We sought to evaluate the clinical response and long-term follow-up in patients with SU under omalizumab treatment. We carried out a retrospective study of patients with SU under omalizumab therapy during January 2010-December 2018 in 2 tertiary hospitals in Spain. Omalizumab treatment was approved by the therapeutic committee, and written informed consent was obtained from all patients. Clinical response was evaluated by using the Urticaria Activity Score (UAS7) and Urticaria Control Test (UCT). Complete clinical response (CCR) was defined as having a UAS7 equal to zero. UCT score (controlled disease >12) and adverse effects were also analyzed. All patients underwent baseline phototesting according to the Spanish Photobiology Group protocols.4Pérez Ferriols A. Aguilera J. Aguilera P. et al.Determination of minimal erythema dose and anomalous reactions to UVA radiation by skin phototype.Actas Dermosifiliogr. 2014; 105: 780-788Google Scholar In all, 21 patients were found, but 1 patient was excluded because of the concomitance of severe chronic spontaneous urticaria. Twenty patients (7 men and 13 women) of a median age of 41 (range 19-74) years were included, and 7 of these patients have been previously described.3Morgado-Carrasco D. Fustà-Novell X. Podlipnik S. Combalia A. Aguilera P. Clinical and photobiological response in eight patients with solar urticaria under treatment with omalizumab, and review of the literature.Photodermatol Photoimmunol Photomed. 2018; 34: 194-199Crossref Scopus (12) Google Scholar The most frequently implicated light spectra were visible light and ultraviolet A (Table I). The starting dose of omalizumab was 300 mg/4 weeks for 19 patients. Median time under omalizumab therapy was 24.5 (range 4-86) months.Table IClinical and epidemiologic characteristics of patients with refractory solar urticaria under omalizumab therapyCharacteristicValueSex Male7 (35) Female13 (65)Age, y, median (range)41 (19-74)Duration of solar urticaria, y, median (range)4 (0.8-16)Atopic-associated disorders Yes2 (10) No18 (90)Baseline serum IgE levels, UI/L, median (range)253.5 (30-2874)Baseline serum IgE Within reference range3 (21.4) Elevated11 (78.6)Previous treatments High-dose antihistamines20 (100) Phototherapy6 (30) Immunoglobulin1 (5) Antimalarials1 (5) Beta carotenes1 (5)Implicated light spectrum Ultraviolet A13 (65) Ultraviolet B7 (35) Visible light13 (65) Normal2 (10)Values are n (%) unless otherwise specified. Open table in a new tab Values are n (%) unless otherwise specified. CCR was achieved and maintained in 90% (18/20) of cases. Median time to CCR was 2.5 (range 1-18) months; in 33.3% (6/18) of cases, CCR required ≥4 months. All patients with CCR presented a UCT >12. Doses of omalizumab to achieve CCR were 300 mg/4 weeks in 16 patients and 450 mg/4 weeks in 2 patients. Doses could be reduced in 6 patients with maintained CCR (Table II). Incremental dosages (450 mg/4 weeks and 600 mg/4 weeks) were administered in 2 individuals because of a loss of clinical response; both patients maintained CCR with the new dosage. Three individuals discontinued omalizumab therapy: 1 (with CCR) was lost to follow-up and 2 discontinued because of a lack of clinical response. One of these 2 received omalizumab 150 mg/4 weeks with no clinical improvement and suspended it after 4 months, and the other was started on omalizumab 300 mg/4 weeks, increased to 450 mg/4 weeks with only a mild response, and stopped omalizumab after 13 months. Phototesting under omalizumab treatment was performed in 11 patients; results were normal in 5 patients and remained altered in 6 (2 with no clinical response; Table II). No moderate or severe adverse effects were reported.Table IIClinical and photobiologic response to omalizumab treatment in patients with solar urticariaCategoryValueStarting dosage, mg/4 wk 150∗Patient given this dosage had no response to treatment. Omalizumab was stopped after 4 months.1 (5) 30019 (95)Dosage when achieving CCR, mg/4 wk 30016 (88.9) 4502 (11.1)Current dosage†The dosage was successfully decreased from 300 mg/4 weeks to 150 mg/4 weeks in 4 patients (after 3, 22, 24, and 42 months of sustained CCR), to 300 mg/6 weeks in 1 patient (after 2 months of sustained CCR), and to 300 mg/8 weeks in another patient. Dosages were increased from 300 mg/4 weeks to 450 mg/4 weeks in 3 patients after 2-12 months (2, 8, and 12 months) without achieving CCR. One patient suspended omalizumab after 13 months because of a lack of clinical response. 150 mg/4 wk4 (20) 300 mg/4 wk8 (40) 300 mg/6 wk1 (5) 300 mg/8 wk1 (5) 450 mg/4 wk2 (10) 600 mg/4 wk1 (5) Suspended treatment‡Two patients suspended omalizumab because of a lack of clinical response. Another moved to a different city after achieving CCR and was lost to follow-up (after 10 months under therapy).3 (15)Time on omalizumab, mon, median (range)24.5 (4-86)Time on omalizumab, mon 2410 (50)Clinical response Complete18 (90) None2 (10)Phototesting results during omalizumab treatment No reaction5 (25) Increased MUD0 (0) Persisting baseline alterations6 (30) Not performed9 (45)Values are n (%) unless otherwise specified.CCR, Complete clinical response; MUD, minimum urticarial dose.∗ Patient given this dosage had no response to treatment. Omalizumab was stopped after 4 months.† The dosage was successfully decreased from 300 mg/4 weeks to 150 mg/4 weeks in 4 patients (after 3, 22, 24, and 42 months of sustained CCR), to 300 mg/6 weeks in 1 patient (after 2 months of sustained CCR), and to 300 mg/8 weeks in another patient. Dosages were increased from 300 mg/4 weeks to 450 mg/4 weeks in 3 patients after 2-12 months (2, 8, and 12 months) without achieving CCR. One patient suspended omalizumab after 13 months because of a lack of clinical response.‡ Two patients suspended omalizumab because of a lack of clinical response. Another moved to a different city after achieving CCR and was lost to follow-up (after 10 months under therapy). Open table in a new tab Values are n (%) unless otherwise specified. CCR, Complete clinical response; MUD, minimum urticarial dose. Omalizumab can be a good alternative treatment for diverse variants of chronic inducible urticaria.5Maurer M. Metz M. Brehler R. et al.Omalizumab treatment in patients with chronic inducible urticaria: a systematic review of published evidence.J Allergy Clin Immunol. 2018; 141: 638-649Abstract Full Text Full Text PDF PubMed Scopus (159) Google Scholar A phase 2 trial in 10 patients with SU showed only a moderate response at week 12, with 30% having a UAS7 of zero.2Aubin F. Avenel-Audran M. Jeanmougin M. et al.Omalizumab in patients with severe and refractory solar urticaria: a phase II multicentric study.J Am Acad Dermatol. 2016; 74: 574-575Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar However, some reviews of the literature have reported complete and partial response with omalizumab in ∼70% of cases.1Snast I. Kremer N. Lapidoth M. et al.Omalizumab for the treatment of solar urticaria: case series and systematic review of the literature.J Allergy Clin Immunol Pract. 2018; 6: 1198-1204.e3Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar, 3Morgado-Carrasco D. Fustà-Novell X. Podlipnik S. Combalia A. Aguilera P. Clinical and photobiological response in eight patients with solar urticaria under treatment with omalizumab, and review of the literature.Photodermatol Photoimmunol Photomed. 2018; 34: 194-199Crossref Scopus (12) Google Scholar, 5Maurer M. Metz M. Brehler R. et al.Omalizumab treatment in patients with chronic inducible urticaria: a systematic review of published evidence.J Allergy Clin Immunol. 2018; 141: 638-649Abstract Full Text Full Text PDF PubMed Scopus (159) Google Scholar Almost all of the patients in our series achieved CCR. One-third did so after 4 months, suggesting that more prolonged therapy is needed. Also 4 patients required higher doses of omalizumab than the 300 mg/4 weeks used in the phase 2 trial to achieve or maintain CCR. Limitations of our study include the retrospective study design and limited number of patients, although this report is the largest case series to date. Omalizumab can be a good and well tolerated long-term therapy for SU. Some patients might need higher doses or more prolonged treatment to achieve CCR.