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448 SHORT COMMUNICATION Combining Omalizumab with Another Biotherapy Anne-Claire FOUGEROUSSE 1 , Pierre-André BECHEREL 2 , Valérie PALLURE 3 , Thierry BOYÉ 4 , Ziad REGUIAI 5 , Germaine GABISON 6 , Hughes BARTHELEMY 7 , Antoine BADAOUI 8 , Emmanuel MAHÉ 8 and Cristina BULAI LIVIDEANU 9 ; for the GEM ResoPso Departments of Dermatology: 1 Military Teaching Hospital Bégin, 69 avenue de Paris, FR-94160 Saint Mandé, 2 Private Hospital of Antony, Antony, 3 Hospital Center of Perpignan, Perpignan, 4 Military Teaching Hospital Sainte-Anne, Toulon, 5 Courlancy Polyclinic, Reims, 7 Hospital Center of Auxerre, Auxerre and 8 Victor Dupouy Hospital Center, Argenteuil, 6 Dermatology practice, Saint-Maurice, and 9 Paul Sabatier University, CReference Center of Mastocytosis (CEREMAST); Department of Dermatology, Toulouse Teaching Hospital, Toulouse, France. E-mail: [email protected] Accepted Feb 5, 2019 ; E-published Feb 6, 2019 Our improved understanding of the chronic inflammatory diseases has enabled the development of biologics, tar- geting multiple pathways, such as tumor necrosis factor (TNF), interleukin (IL)-23, IL-17, IL-1, or the receptor activator of NFᴋB ligand (RANKL), with new indica- tions and biologics constantly emerging. Depending on the pathogenesis of the disease being treated, combina- tion of biologics can target the same or two different pathways, resulting in different safety profiles. Omalizumab, a recombinant humanized monoclonal anti-IgE antibody, has been approved for the management of chronic asthma and chronic spontaneous urticaria (CSU), refractory to H1-antihistamines (1). While its sequential combination with other biologics has already been reported (2), the combined use with another bio­ therapy has only been reported once (3). This retrospective study, involving the GEM Resopso centers, conducted between May 2017 and March 2018, sought to investigate the safety and efficacy of combined biotherapy comprising of omalizumab, dermatologically indicated, and another biologic medication prescribed for dermatological, rheumatological or gastrointestinal indications. The inclusion criteria were: disease diagnosis according to the current guidelines (4); age >18 years; combined omalizumab and another biologic therapy for ≥ 3 months. Patients’ age, sex, underlying disease diagnosis, biotherapy type and duration, CSU disease evolution, CSU disease progression since omalizumab initiation, and adverse events were collected. The study included 6 women and 4 men, with a mean age of 37.6 years (range 21–60) . The biotherapy indica- tion was dermatological (psoriasis) in 7 patients, gastro- enterological in 2 patients (Crohn’s disease and ulcerative colitis), and rheumatological (ankylosing spondylitis) in one patient (Table I). Omalizumab was combined with biologics, such as anti-TNF agents in 9 patients and se- cukinumab in one, with a mean of 40.8 months (range 6–108) of treatment duration. In 9 patients, the indication for omalizumab was CSU, after failure to respond to the antihistamine dose increase; the remaining omalizumab- receiving patients suffered from indolent systemic mas- tocytosis with idiopathic anaphylactic shocks over 132 months. In all 10 patients, omalizumab was initiated after the first biologics, with combined biotherapy duration of a mean of 7 months (range 3–12). The initial biotherapy was pursued in all patients, except for one female pa- tient, who was switched to ustekinumab, following an inadequate psoriasis control by adalimumab. Clinical response to omalizumab proved significant in all but one patient. In 8 CSU patients, complete clinical response, i.e. Urticaria Activity Score (UAS) 7 equal to zero, was achieved with omalizumab and a partial response in one, defined by a 30% decrease in UAS 7. This patient, how­ ever, discontinued antihistamines during observation. With omalizumab, the patient suffering from systemic indolent mastocytosis stopped experiencing idiopathic anaphylactic shocks. The combined biotherapy was well tolerated, with omalizumab producing no adverse Table I. Patient and disease characteristics Patient #1 #2 #3 #4 #5 #6 #7 #8 #9 #10 Age, years/ Sex 28/F 35/F 25/F 21/F 29/M 60/F 25/M 51/M 49/M 53/F Mean 37.6 Biotherapy indication Biotherapy type Psoriasis Psoriasis Psoriasis Crohn’s disease Ankylosing spondylarthritis Psoriasis Ulcerative colitis Psoriasis Psoriasis and psoriasis arthritis Psoriasis Gastrointestinal: 2 Dermatology: 7 Rheumatology: 1 Secukinumab Adalimumab Adalimumab Infliximab Etanercept Infliximab Adalimumab Etanercept Etanercept Etanercept ETN: 4 IFX: 2 ADA: 3 SECU: 1 Biotherapy duration, months CSU duration, months Omalizumab treatment duration, months 6 9 64 18 48 72 10 36 37 108 40.8 12 24 84 12 60 24 10 144 NA 2 41.3 3 8 9 4 9 3 7 10 12 12 7 CSU: chronic spontaneous urticaria; ETN: etanercept; IFX: infliximab; ADA: adalimumab; SECU: secukinumab; NA: not available. doi: 10.2340/00015555-3140 Acta Derm Venereol 2019; 99: 448–449 This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2019 Acta Dermato-Venereologica.