THU0307 RESPONSE OF BEHÇET'S REFRACTORY ORAL AND/OR GENITAL ULCERS TO APREMILAST IN COMBINATION VS MONOTHERAPY. NATIONAL MULTICENTER STUDY OF 51 CASES OF CLINICAL PRACTICE. (2nd June 2020)
- Record Type:
- Journal Article
- Title:
- THU0307 RESPONSE OF BEHÇET'S REFRACTORY ORAL AND/OR GENITAL ULCERS TO APREMILAST IN COMBINATION VS MONOTHERAPY. NATIONAL MULTICENTER STUDY OF 51 CASES OF CLINICAL PRACTICE. (2nd June 2020)
- Main Title:
- THU0307 RESPONSE OF BEHÇET'S REFRACTORY ORAL AND/OR GENITAL ULCERS TO APREMILAST IN COMBINATION VS MONOTHERAPY. NATIONAL MULTICENTER STUDY OF 51 CASES OF CLINICAL PRACTICE
- Authors:
- Herrero Morant, A.
Atienza Mateo, B.
Loricera, J.
Calvo del Rio, V.
Martín-Varillas, J. L.
Graña, J.
Espinosa, G.
Moriano, C.
Pérez Sandoval, T.
Martín Martínez, M.
Diez, E.
García-Armario, M. D.
Martínez, E.
Castellví, I.
Moya Alvarado, P.
Sivera, F.
Calvo, J.
De la Morena, I.
Ortiz Sanjuán, F.
Román Ivorra, J. A.
Pérez Gómez, A.
Heredia, S.
Olive, A.
Prior, Á.
Díez, C.
Alegre-Sancho, J. J.
Ybáñez-García, D.
Martínez-Ferrer, Á.
Narváez, J.
Figueras, I.
Turrión, A. I.
Romero-Yuste, S.
Trénor, P.
Ojeda, S.
González-Gay, M. Á.
Blanco, R.
… (more) - Abstract:
- Abstract : Background: Apremilast (APR) has demonstrated efficacy in the treatment of oral and/or genital aphthous ulcers in Behçet´s disease (BD). Combination of APR to other disease-modifying anti-rheumatic drugs (DMARDs) has not been assessed. Objectives: To compare the efficacy and safety of APR in monotherapy or combined with DMARDs in refractory BD. Methods: National multicenter open-label study on 51 BD patients with oral and/or genital ulcers refractory to conventional treatment. 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 drugs. The main clinical symptoms for starting APR were oral (n=19) and genital (2) aphthous ulcers or both (30). Excluding corticosteroids, colchicine or NSAIDs, APR was given at standard dose of 30 mg twice daily in monotherapy (n=31), or combined with conventional DMARDs in 16 cases (6 azathioprine, 5 methotrexate, 4 hydroxychloroquine, 4 sulfasalazine, 1 dapsone) or with biologic DMARDs in 4 (2 tocilizumab, 1 adalimumab, 1 infliximab). There were not found statistically significant differences in demographic features, previous therapy, clinical manifestations or reported adverse effects. After a median follow-up of 6 [3-12] months, most of the patients experienced improvement of the orogenital ulcers in both groups (89.8% in the first 2 weeks), without statistically significant differences. (TABLE ) Conclusion: APR leads to a rapid andAbstract : Background: Apremilast (APR) has demonstrated efficacy in the treatment of oral and/or genital aphthous ulcers in Behçet´s disease (BD). Combination of APR to other disease-modifying anti-rheumatic drugs (DMARDs) has not been assessed. Objectives: To compare the efficacy and safety of APR in monotherapy or combined with DMARDs in refractory BD. Methods: National multicenter open-label study on 51 BD patients with oral and/or genital ulcers refractory to conventional treatment. 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 drugs. The main clinical symptoms for starting APR were oral (n=19) and genital (2) aphthous ulcers or both (30). Excluding corticosteroids, colchicine or NSAIDs, APR was given at standard dose of 30 mg twice daily in monotherapy (n=31), or combined with conventional DMARDs in 16 cases (6 azathioprine, 5 methotrexate, 4 hydroxychloroquine, 4 sulfasalazine, 1 dapsone) or with biologic DMARDs in 4 (2 tocilizumab, 1 adalimumab, 1 infliximab). There were not found statistically significant differences in demographic features, previous therapy, clinical manifestations or reported adverse effects. After a median follow-up of 6 [3-12] months, most of the patients experienced improvement of the orogenital ulcers in both groups (89.8% in the first 2 weeks), without statistically significant differences. (TABLE ) Conclusion: APR leads to a rapid and maintained improvement in most patients with refractory BD orogenital ulcers. APR seems as effective and safe in monotherapy as combined. Disclosure 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, Jenaro Graña: None declared, Gerard Espinosa: 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, Sergi Heredia: None declared, Alejandro Olive: None declared, Águeda Prior: None declared, Carolina Díez: None declared, Juanjo J Alegre-Sancho Consultant of: UCB, Roche, Sanofi, Boehringer, Celltrion, Paid instructor for: GSK, Speakers bureau: MSD, GSK, Lilly, Sanofi, Roche, UCB, Actelion, Pfizer, Abbvie, Novartis, D Ybáñez-García Speakers bureau: Lilly, Roche, Sanofi, Ángels Martínez-Ferrer: None declared, J. Narváez: 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 … (more)
- Is Part Of:
- Annals of the rheumatic diseases. Volume 79(2020)Supplement 1
- Journal:
- Annals of the rheumatic diseases
- Issue:
- Volume 79(2020)Supplement 1
- Issue Display:
- Volume 79, Issue 1 (2020)
- Year:
- 2020
- Volume:
- 79
- Issue:
- 1
- Issue Sort Value:
- 2020-0079-0001-0000
- Page Start:
- 382
- Page End:
- 382
- Publication Date:
- 2020-06-02
- Subjects:
- Rheumatism -- Periodicals
616.723005 - Journal URLs:
- http://ard.bmjjournals.com/ ↗
http://www.pubmedcentral.nih.gov/tocrender.fcgi?journal=149&action=archive ↗
http://www.bmj.com/archive ↗
http://gateway.ovid.com/server3/ovidweb.cgi?T=JS&MODE=ovid&D=ovft&PAGE=titles&SEARCH=annals+of+the+rheumatic+diseases.tj&NEWS=N ↗ - DOI:
- 10.1136/annrheumdis-2020-eular.6246 ↗
- Languages:
- English
- ISSNs:
- 0003-4967
- Deposit Type:
- Legaldeposit
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