ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2854

Effect of Apremilast on Quality of Life and Physical Function in Patients with Behçet’s Syndrome

Gulen Hatemi1, Melike Melikoglu1, Recep Tunc2, Cengiz Korkmaz3, Banu Turgut Ozturk4, Cem Mat5, Peter A. Merkel6, Kenneth Calamia7, Lilia Pineda8, Ziqi Liu8, Randall M. Stevens8, Hasan Yazici1 and Yusuf Yazici9, 1Istanbul University, Cerrahpasa Medical Faculty, Rheumatology, Istanbul, Turkey, 2Necmettin Erbakan University, Meram Medical Faculty,Division of Rheumatology, Konya, Turkey, 3EskiÅŸehir Osmangazi University, EskiÅŸehir, Turkey, 4Selçuk University, Konya, Turkey, 5Istanbul University, Cerrahpasa Medical Faculty, Dermatology, Istanbul, Turkey, 6Vasculitis Center, Division of Rheumatology, University of Pennsylvania, Philadelphia, PA, 7Administration, Mayo Clinic Health System in Waycross, Waycross, GA, 8Celgene Corporation, Warren, NJ, 9Department of Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Vasculitis III

Session Type: Abstract Submissions (ACR)

Background/Purpose:  The oral ulcers in Behçet’s syndrome (BS) can be painful, causing difficulty in eating and speaking, and can impair the quality of life. Apremilast is an oral phosphodiesterase 4 inhibitor that modulates inflammatory pathways. A clinical trial demonstrated a beneficial effect on oral ulcers with this agent. For this study, we aimed to assess whether apremilast is effective in improving quality of life in patients with BS.

Methods: This was a phase 2, multicenter, controlled study of 111 patients with BS, without major organ involvement but with ≥2 oral ulcers, who were randomized to apremilast 30 mg BID or placebo for 12 weeks, followed by a 12-week active-treatment period for all patients. The primary outcome, which was the number of oral ulcers at Week 12, and secondary outcomes at Week 12, including oral ulcer pain, number of genital ulcers, number of patients with a complete or partial response, number of genital ulcers, and disease activity assessed by the BS activity scale (BSAS) and Behçet’s disease current activity form, have already been reported. We now report the results of health related quality of life measurements from the trial as assessed using the Behçet’s disease quality of life (BDQoL) questionnaire and the 36-item Short-Form Health Survey version 2 (SF-36v2). Patients in the trial completed each of these instruments at baseline and at Week 12. 

Results:  The mean ± SD BDQoL score showed a significantly greater improvement from baseline at Week 12 with apremilast vs. placebo (-4.5 ± 7.61 vs. -1.6 ± 5.30; p=0.0397). The mean ± SD SF-36v2 physical component summary scores were significantly higher (improved) at Week 12 with apremilast vs. placebo (4.72 ± 9.45 vs. -1.70 ± 7.78; P=0.0011). The mean scores were significantly improved with apremilast for the SF-36v2 subscales of physical function, bodily pain, and general health perceptions at Week 12.

Conclusion:  Treatment with Apremilast improved quality of life and physical function in patients with BS.

Disclosure:

G. Hatemi,
None;

M. Melikoglu,
None;

R. Tunc,
None;

C. Korkmaz,
None;

B. Turgut Ozturk,
None;

C. Mat,
None;

P. A. Merkel,

Celgene,

2;

K. Calamia,
None;

L. Pineda,

Celgene,

3;

Z. Liu,

Celgene,

3;

R. M. Stevens,

Celgene Corporation,

1,

Celgene Corporation,

3;

H. Yazici,
None;

Y. Yazici,

Celgene,

2.

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