Background Oral and/or genital aphthous ulcers are the most common symptoms of Behçet´s disease (BD), and are often refractory to conventional treatment. The inhibitor of phosphodiesterase-4 apremilast (APR) has demonstrated efficacy in the treatment of this manifestations. The objective of the present study was to assess the efficacy of APR in the management of refractory oral and/or genital ulcers in patients with BD. Methods National multicenter open-label observational study on BD patients with recurrent oral and/or genital ulcers. In all cases orogenital ulcers were refractory to conventional therapy. APR was given and maintained at standard dose of 30 mg twice daily. The main outcome was the achievement of oral and/or genital ulcers remission. Efficacy of APR for other clinical manifestations was also evaluated. Results We included 51 patients (35 women/16 men; mean age 44.7 ± 13.2 years). Before APR, all patients had received several systemic conventional and/or biologic drugs. APR was initiated because of refractory oral (n = 19) or genital (n = 2) aphthous ulcers or both (n = 30). Other manifestations found at APR onset were arthralgia/arthritis (n = 16), folliculitis/pseudofolliculitis (n = 14), erythema nodosum (n = 3), furunculosis (n = 2), paradoxical psoriasis induced by TNFα-inhibitors (n = 2), ileitis (n = 2), deep venous thrombosis (n = 2), leg ulcers (n = 1), erythematosus and scaly skin lesions (n = 1), fever (n = 1), unilateral anterior uveitis (n = 1) and neurobehçet (n = 1). After a mean follow-up of 8.5 ± 6.9 months, most patients had experienced improvement of orogenital ulcers and prednisone dose had been successfully reduced or discontinued. APR also yielded improvement of some non-aphthous manifestations such as the cutaneous follicular and intestinal manifestations. However, the effect on musculoskeletal manifestations was variable. Conclusion APR yielded a rapid and maintained improvement of refractory mucocutaneous ulcers of BD, even in patients refractory to several systemic drugs including biologic therapy.
Background The role of the nursing consultation in rheumatology is becoming more prevalent, especially in patient monitoring, reducing the burden of care of rheumatologists in many cases where in-person consultation with the rheumatologist is not required. Objectives To analyze the usefulness of telephone consultation to nursing staff to resolve doubts and/or health incidents to rheumatic patients and to assess the involvement of physicians on it. Methods We collected clinical data for the period between June 2012 and January 2013 of all telephone consultation received in the nursing department: clinical and laboratory data, number of calls, characteristics of the proposed consultation and its resolution, and involvement of the rheumatologist in consultations. Results We registered 122 telephone consultations, in which 77% of cases the nursing staff resolved the consultation (72% of them require the nurse consultant support by the rheumatologist) and in 88.5% of all consultations have required an additional call from the nursing. From the 23% of the queries unresolved by nurses (n=28), 19 cases required telephone consultation with the patient’s rheumatologist, and 7 cases were derived to an in-person appointment with the doctor (5 cases the rheumatologist, 1 to Emergency door and 1 to Primary Care). Patients who performed telephone consultations are mostly diagnosed as rheumatoid arthritis (40.2%), ankylosing spondylitis (13.1%) and systemic lupus erythematous (9.8%). 49.2% of the patients were treated with methotrexate, and 35.3% received biologic therapy. Consultations by patients are for different reasons, but the 22.9% of consultations were supply problems in medication, 19.7% were disease outbreaks and 9.8% to check analytical results. Conclusions Telephone consultation to nurse staff contributes greatly to answer questions from patients about disease outbreaks, as well as problems in treatment and/or analytical results, without the presence of the rheumatologist. It also prevents unnecessary movement of patients, reducing the number of telephone consultations and medical attendance, and helping manage health hospital resources effectively. Disclosure of Interest None Declared
BackgroundBehçet’s disease (BD) is characterised by recurrent oral and/or genital ulcers accompanied by ocular, cutaneous, articular, gastrointestinal, and/or neurologic manifestations. Oral and/or genital aphthous ulcers are often refractory to conventional treatment. Apremilast is an orally-active small molecule which inhibits phosphodiesterase-4 (PDE-4) that modulates some inflammatory pathways.ObjectivesOur aim was to assess the efficacy of apremilast in BD patients with oral and/or genital ulcers refractory to conventional treatment.MethodsRetrospective national multicenter open-label study on 19 BD patients treated with apremilast at standard dose of 30 mg twice daily. The main outcome was achievement of oral ulcers remission.ResultsWe included 19 patients (14 women and 5 men) with a mean age of 43.6±14.8 years. Before apremilast, all patients had also received several systemic conventional drugs: oral corticosteroids (n=18), colchicine (n=19), NSAIDs (n=10), methotrexate (n=10), azathioprine (n=10), cyclosporine (n=6), infliximab (n=3), adalimumab (n=5), dapsone (n=3), etanercept (n=1), mycophenolate mofetil (n=1), tocilizumab (n=1). The main clinical symptoms for starting apremilast were oral aphthous ulcers (n=19) and genital ulcers (n=14). Other manifestations present at apremilast onset were arthralgia/arthritis (n=6), folliculitis/pseudofolliculitis (n=6), asthenia (n=5), furunculosis (n=1), erythema nodosum (n=1), erythematosus and scaly skin lesions (n=1), psoriasis (n=1), deep venous thrombosis (n=2) and ileitis (n=1). Table 1 shows the evolution of the patients. After a median follow-up of 6 [interquartile range, 5–10] months, most of the patients experienced clinical improvement. In this period of time, 11 patients developed any side-effect: dyspepsia (n=5), nauseas (n=4), diarrhoea (n=4), abdominal pain (n=4), headache (n=3), loss of appetite (n=3), weight loss (n=1) and halitosis (n=1). Three patients had to reduce the dose to 30 mg/day. Apremilast was discontinued in 4 patients: because of not obtaining the expected improvement (n=2), due to desire of pregnancy (n=1) and due to development of neurological involvement (n=1).Abstract FRI0489 – Table 1ConclusionsApremilast leads to a rapid and maintained improvement in many patients with refractory mucocutaneous ulcers of BD. Even in patients refractory to several systemic drugs including biologic therapy. However, the development of adverse digestive effects is frequent.Disclosure of InterestNone declared
Background:Oral and/or genital aphthous ulcers are the most common symptoms of Behçet’s disease (BD), and are often refractory to conventional treatment. The inhibitor of phosphodiesterase-4 Apremilast (APR) has demonstrated efficacy in the treatment of this manifestations.Objectives:To assess the efficacy and safety of APR in BD patients with oral and/or genital ulcers refractory to conventional treatment.Methods:National multicenter open-label study on 49 BD patients treated with APR at maintained standard dose of 30 mg twice daily, with the initial 5-day titration schedule in 38 cases. The main outcome was achievement of oral and/or genital ulcers remission.Results:We included 49 patients (35 women/14 men), mean age of 44.5±13.4 years. Before APR, all patients had received several systemic conventional and/or biological drugs: oral corticosteroids (n=45), colchicine (n=48), NSAIDs (n=21), methotrexate (n=27), azathioprine (n=23), cyclosporine (n=9), dapsone (n=6), adalimumab (n=12), infliximab (n=8), tocilizumab (n=3), etanercept (n=3), sulfasalazine (n=2), cyclophosphamide (n=2) and/or others (pentoxifylline, thalidomide, mycophenolate mofetil, hydroxychloroquine, golimumab, 1 each). The main clinical symptoms for starting APR were oral (n=18) and genital (n=2) aphthous ulcers or both (n=29). After a mean follow-up of 8.3±6.8 months, most of the patients experienced main clinical improvement and prednisone dose was reduced or discontinued (TABLE). In this period of time, 31 patients developed any side-effect, most of them transitory: nausea (n=12), diarrhea (n=11), dyspepsia (n=9), abdominal pain (n=7), headache (n=5), loss of appetite (n=4), weight loss (n=3), halitosis (n=1), dry mouth (n=1), palpitations (n=1) and/or depression (n=1). Six patients had to reduce the dose to 30 mg/day. APR was discontinued in 11 patients due to: not obtaining the expected improvement (n=5), intense gastrointestinal adverse effects (n=3), desire of pregnancy (n=1), persistent erythema nodosum (n=1) and development of neurological involvement (n=1).Conclusion:Our data show a rapid and maintained improvement with APR in patients with mucocutaneous ulcers of BD refractory to several systemic drugs, including biologic therapy.References:[1] Davatchi F, et al. The International Criteria for Behçet’s Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatology Venereol. 2014;28(3):338–47.[2] Gulen Hatemi, et al. Apremilast for Behçet’s Syndrome — A Phase 2, Placebo-Controlled Study. N Engl J Med 2015; 372:1510-1518.Disclosure of Interests:Belén Atienza-Mateo: None declared, José Luis Martín-Varillas: None declared, J. Loricera: None declared, Vanesa Calvo-Río: None declared, Jenaro Graña: None declared, Gerard Espinosa: None declared, Clara Moriano: None declared, Trinidad Pérez-Sandoval: None declared, Manuel Martín-Martínez: None declared, Elvira Diez Alvarez: None declared, María Dolores García-Armario: None declared, Esperanza Martínez: None declared, Ivan C...
Background:Apremilast (APR) has demonstrated efficacy in orogenital ulcers of Behçet´s disease (BD). Response of other clinical manifestations remains unknown.Objectives:To assess the efficacy and safety of APR in monotherapy or combined with disease-modifying anti-rheumatic drugs (DMARDs) in non-aphthous ulcers of BD.Methods:National multicenter open-label study on 34 BD patients treated with APR at maintained standard dose of 30 mg twice daily.Results:From a cohort of 51 patients with APR by refractory orogenital ulcers of BD, we selected 34 (24 women/10 men, mean age 43.8±14.3 years), cases with another clinical manifestation/s.Excluding CTs, colchicine or NSAIDs, APR was given in monotherapy (n=21) or combined with conventional and/or biologic DMARDs in 13 cases (5 methotrexate, 3 azathioprine, 3 hydroxychloroquine, 1 sulfasalazine, 1 dapsone, 2 tocilizumab, 1 IFX). Other active manifestations present at APR onset were: arthralgia/arthritis (16, true arthritis in 5), folliculitis/pseudofolliculitis (14), erythema nodosum (3), furunculosis (2), paradoxical psoriasis by TNFi (2), intestinal ileitis (2), deep venous thrombosis (2), leg ulcers (1), erythematosus and scaly skin lesions (1), fever (1), unilateral anterior uveitis (1) and neurobehçet (1).After a median follow-up of 6 [3-12] months, folliculitis and ileitis improved, neurobehçet remained stable and musculoskeletal manifestations evolved in a variable way.(TABLE)TABLE.Conclusion:In addition of orogenital ulcers, APR in monotherapy or combined, seems to be useful in skin manifestations of BDDisclosure of Interests:Alba Herrero Morant: None declared, Belen Atienza Mateo: None declared, J. Loricera: None declared, Vanesa Calvo del Rio Grant/research support from: MSD and Roche, Speakers bureau: Abbott, Lilly, Celgene, Grünenthal, UCB Pharma, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Gerard Espinosa: None declared, Jenaro Graña: None declared, Clara Moriano: None declared, Trinidad Pérez Sandoval: None declared, Manuel Martín Martínez: None declared, Elvira Diez: None declared, María Dolores García-Armario: None declared, Esperanza Martínez: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, Patricia Moya Alvarado: None declared, Francisca Sivera: None declared, Jaime Calvo Grant/research support from: Lilly, UCB, Consultant of: Abbvie, Jansen, Celgene, Isabel de la Morena: None declared, Francisco Ortiz Sanjuán: None declared, José Andrés Román Ivorra: None declared, Ana Pérez Gómez: None declared, Alejandro Olive: None declared, Carolina Díez: None declared, Juan José Alegre: None declared, D Ybáñez-García Speakers bureau: Lilly, Roche, Sanofi, Ángels Martínez-Ferrer: None declared, Javier Narvaez: None declared, Ignasi Figueras: None declared, Ana Isabel Turrión: None declared, Susana Romero-Yuste: None declared, Pilar Trénor: None declared, Soledad Ojeda Speakers bureau: AMGEN, LILLY, GEBRO, Miguel Á. González-Gay Grant/research support from: AbbVie, MSD and Roche, Speakers bureau: AbbVie, MSD and Roche, Ricardo Blanco Grant/research support from: Abbvie, MSD and Roche, Consultant of: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly and MSD
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