PMID- 31280296
OWN - NLM
STAT- MEDLINE
DCOM- 20200420
LR  - 20200420
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 59
IP  - 1
DP  - 2020 Jan 1
TI  - Efficacy and safety of apremilast for Behcet's syndrome: a real-life 
      single-centre Italian experience.
PG  - 171-175
LID - 10.1093/rheumatology/kez267 [doi]
AB  - OBJECTIVES: To evaluate the efficacy and safety of apremilast in treating oral 
      ulcers (OUs), the cardinal and high-disabling feature of Behcet's disease (BD). 
      METHODS: Twelve consecutive patients affected by BD with recurrent/relapsing OUs 
      resistant and/or intolerant to conventional therapy were enrolled and 
      prospectively followed. The primary endpoint was the number of OUs at week 12. 
      Secondary endpoints were modification from baseline to week 12 in Behcet's 
      Syndrome Activity Score (BSAS), Behcet's Disease Current Activity Form (BDCAF) 
      score, Behcet's Disease Quality of Life (BDQOL) scale and pain of OUs, as 
      measured by a visual analogue scale (VAS). All adverse events (AEs) were recorded 
      during follow-up. Non-parametric tests (Wilcoxon rank test) were used and a 
      P-value <0.05 was considered statistically significant. RESULTS: After 12 weeks 
      of apremilast, there was a significant reduction in the number of OUs [0.58 (s.d. 
      0.67) vs 3.33 (s.d. 1.45) at baseline, P = 0.02] that was paralleled by 
      improvement in disease activity: BSAS was 16.8 (s.d. 9.1) [from 45.9 (s.d. 19.6) 
      at baseline] (P = 0.02), BDCAF score was 0.72 (s.d. 0.65) [vs 2.45 (s.d. 1.0) at 
      baseline] (P = 0.04) and the VAS score for pain decreased to 23.3 (s.d. 13.7) [vs 
      67.9 (s.d. 17.2) at baseline] (P = 0.02). Consistently, an improvement of BDQOL 
      was assessed (P = 0.02). Clinical improvement led to complete steroid 
      discontinuation in six patients and a tapering of the prednisone dose in two 
      patients (P = 0.016). Colchicine was discontinued in six of nine patients (P = 
      0.031). AEs related to apremilast occurred in four patients (mainly due to 
      gastrointestinal AEs), leading to drug discontinuation in all of them. 
      CONCLUSION: Our preliminary real-world data support the use of apremilast as an 
      effective therapeutic strategy against BD-related recurrent OUs resistant or 
      intolerant to first-line therapy.
CI  - (c) The Author(s) 2019. Published by Oxford University Press on behalf of the 
      British Society for Rheumatology. All rights reserved. For permissions, please 
      email: journals.permissions@oup.com.
FAU - De Luca, Giacomo
AU  - De Luca G
AD  - Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele 
      Hospital, Milan, Italy.
AD  - Vita-Salute San Raffaele University, Milan, Italy.
FAU - Cariddi, Adriana
AU  - Cariddi A
AD  - Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele 
      Hospital, Milan, Italy.
AD  - Vita-Salute San Raffaele University, Milan, Italy.
FAU - Campochiaro, Corrado
AU  - Campochiaro C
AD  - Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele 
      Hospital, Milan, Italy.
AD  - Vita-Salute San Raffaele University, Milan, Italy.
FAU - Vanni, Daniele
AU  - Vanni D
AD  - Vita-Salute San Raffaele University, Milan, Italy.
FAU - Boffini, Nicola
AU  - Boffini N
AD  - Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele 
      Hospital, Milan, Italy.
FAU - Tomelleri, Alessandro
AU  - Tomelleri A
AD  - Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele 
      Hospital, Milan, Italy.
AD  - Vita-Salute San Raffaele University, Milan, Italy.
FAU - Cavalli, Giulio
AU  - Cavalli G
AD  - Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele 
      Hospital, Milan, Italy.
AD  - Vita-Salute San Raffaele University, Milan, Italy.
FAU - Dagna, Lorenzo
AU  - Dagna L
AD  - Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele 
      Hospital, Milan, Italy.
AD  - Vita-Salute San Raffaele University, Milan, Italy.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - UP7QBP99PN (apremilast)
SB  - IM
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage
MH  - Behcet Syndrome/complications/*drug therapy/epidemiology
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Italy/epidemiology
MH  - Male
MH  - Mouth Mucosa/*pathology
MH  - Oral Ulcer/drug therapy/epidemiology/etiology
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Recurrence
MH  - Thalidomide/administration & dosage/*analogs & derivatives
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Behcet's disease
OT  - apremilast
OT  - oral ulcers
EDAT- 2019/07/08 06:00
MHDA- 2020/04/21 06:00
CRDT- 2019/07/08 06:00
PHST- 2019/04/03 00:00 [received]
PHST- 2019/06/03 00:00 [revised]
PHST- 2019/07/08 06:00 [pubmed]
PHST- 2020/04/21 06:00 [medline]
PHST- 2019/07/08 06:00 [entrez]
AID - 5529163 [pii]
AID - 10.1093/rheumatology/kez267 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2020 Jan 1;59(1):171-175. doi: 
      10.1093/rheumatology/kez267.