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Management of Behcet syndrome
Yazici, Yusuf
PURPOSE OF REVIEW/OBJECTIVE:New treatment options have been studied over the last several years, with a recent approval, a first for Behcet syndrome, in the United States. New management guidelines have also been published, helping with this nowadays more commonly recognized condition's management. The goal of this review is to summarize the most important and potentially clinically relevant recent developments and discuss their impact in the management of patients with Behcet syndrome. RECENT FINDINGS/RESULTS:Apremilast is now approved for the treatment of oral ulcer of Behcet syndrome in the United States. It's possible benefits in controlling nonoral ulcer features of the syndrome are awaited. Long-term use of tumor necrosis factor inhibitors for the treatment of especially eye disease in Behcet syndrome seems to be safe and efficacious. New treatment options such as ustekinumab, secukinumab, tocilizumab and others have early promising data but more studies are needed to better clarify their role in Behcet management. SUMMARY/CONCLUSIONS:The last 2 years have not only seen the approval of the first drug specifically labeled for the treatment of Behcet syndrome in the case of apremilast, many groups have also presented and published their findings on promising new therapeutic agents, which may soon be added to our tools in treating this condition. We also know more about other drugs, such as tumor necrosis factor inhibitors as many patients have been on these for long periods of time, and long-term follow-up data seem to confirm their role in Behcet treatment. Lack of placebo controlled, randomized trials, for the most part, are still outstanding issues.
PMID: 31609785
ISSN: 1531-6963
CID: 4140232
Metaanalyses, Network Metaanalyses, and Systematic Reviews: The Perpetual Motion Machine All Over Again [Editorial]
Yazici, Yusuf
PMID: 31894089
ISSN: 0315-162x
CID: 4251552
Editorial: Introduction, vasculitis 2020 [Editorial]
Yazici, Hasan; Yazici, Yusuf
PMID: 31789993
ISSN: 1531-6963
CID: 4218002
EFFICACY OF APREMILAST FOR THE PAIN OF ORAL ULCERS ASSOCIATED WITH ACTIVE BEHCET'S SYNDROME: 12-WEEK RESULTS FROM THE RANDOMIZED, PHASE III RELIEF STUDY [Meeting Abstract]
Hatemi, G.; Mahr, A.; Takeno, M.; Kim, D.; Melikoglu, M.; Cheng, S.; Mccue, S.; Richter, S.; Brunori, M.; Paris, M.; Chen, M.; Yazici, Y.
ISI:000555905000030
ISSN: 0003-4967
CID: 4562802
Functional status measures and indices in rheumatoid arthritis: comment on the articles by Barber et al and England et al [Letter]
Schmukler, Juan; Block, Joel A.; Pincus, Theodore; Yazici, Yusuf; Gibson, Kathryn A.
ISI:000546113200001
ISSN: 2151-464x
CID: 4526622
EFFECT OF HYDROXYCHLOROQUINE TREATMENT IN MUCOCUTANEOUS MANIFESTATIONS IN PATIENTS WITH BEHCET'S SYNDROME [Meeting Abstract]
Kerstens, F.; Mohamed, S.; Visman, I.; Turkstra, F.; Swearingen, C.; Yazici, Y.
ISI:000555905005171
ISSN: 0003-4967
CID: 4562962
EFFICACY OF APREMILAST FOR THE TREATMENT OF GENITAL ULCERS ASSOCIATED WITH ACTIVE BEHCET'S SYNDROME: A COMBINED ANALYSIS OF TWO RANDOMIZED CONTROLLED TRIALS [Meeting Abstract]
Hatemi, G.; Mahr, A.; Takeno, M.; Kim, D.; Melikoglu, M.; Cheng, S.; Mccue, S.; Richter, S.; Brunori, M.; Paris, M.; Chen, M.; Yazici, Y.
ISI:000555905005116
ISSN: 0003-4967
CID: 4562952
PENTOXYFILLINE GEL FOR ORAL ULCERS IN PATIENTS WITH BEHCET'S SYNDROME [Meeting Abstract]
Hatemi, G.; Yurttas, B.; Kutlubay, Z.; Cote, T.; Derkunt, S. B.; Yazici, Y.; Yazici, H.
ISI:000555905003334
ISSN: 0003-4967
CID: 4562942
Trial of Apremilast for Oral Ulcers in Behçet's Syndrome
Hatemi, Gülen; Mahr, Alfred; Ishigatsubo, Yoshiaki; Song, Yeong-Wook; Takeno, Mitsuhiro; Kim, Doyoung; Melikoğlu, Melike; Cheng, Sue; McCue, Shannon; Paris, Maria; Chen, Mindy; Yazici, Yusuf
BACKGROUND:The small-molecule phosphodiesterase 4 inhibitor apremilast modulates cytokines that are up-regulated in Behçet's syndrome. In a phase 2 trial involving patients with Behçet's syndrome, apremilast reduced the incidence and severity of oral ulcers. Data on the efficacy and safety of apremilast in patients with Behçet's syndrome who had active oral ulcers and had not previously received biologic agents are limited. METHODS:In a phase 3 trial, we randomly assigned, in a 1:1 ratio, patients who had Behçet's syndrome with active oral ulcers but no major organ involvement to receive either apremilast at a dose of 30 mg or placebo, administered orally, twice daily for 12 weeks, followed by a 52-week extension phase. The primary end point was the area under the curve (AUC) for the total number of oral ulcers during the 12-week placebo-controlled period (with lower values indicating fewer ulcers). There were 13 secondary end points, including complete response of oral ulcers, change from baseline in pain associated with oral ulcers, disease activity, and change from baseline in the Behçet's Disease Quality of Life score (range, 0 to 30, with higher scores indicating greater impairment in quality of life). Safety was also assessed. RESULTS:A total of 207 patients underwent randomization (104 patients to the apremilast group and 103 to the placebo group). The AUC for the number of oral ulcers was 129.5 for apremilast, as compared with 222.1 for placebo (least-squares mean difference, -92.6; 95% confidence interval [CI], -130.6 to -54.6; P<0.001). The change from baseline in the Behçet's Disease Quality of Life score was -4.3 points in the apremilast group, as compared with -1.2 points in the placebo group (least-squares mean difference, -3.1 points; 95% CI, -4.9 to -1.3). Adverse events with apremilast included diarrhea, nausea, and headache. CONCLUSIONS:In patients with oral ulcers associated with Behçet's syndrome, apremilast resulted in a greater reduction in the number of oral ulcers than placebo but was associated with adverse events, including diarrhea, nausea, and headache. (Funded by Celgene; ClinicalTrials.gov number, NCT02307513.).
PMID: 31722152
ISSN: 1533-4406
CID: 4185502
Improvements in quality of life in Behcet syndrome patients treated with apremilast: A phase III randomized, double-blind, placebo-controlled study (RELIEF) [Meeting Abstract]
Mahr, A; Takeno, M; Kim, D -Y; Melikoglu, M; Cheng, S; McCue, S; Paris, M; Chen, M; Yazici, Y
Background: Behcet syndrome is a chronic, multisystem inflammatory disorder characterized by painful, recurrent oral ulcers (OU) that can impair quality of life (QoL). Apremilast (APR), an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in the treatment of OU of Behcet's syndrome in a phase III, multicenter, randomized, double-blind, placebo (PBO)-controlled study (RELIEF).
Method(s): A total of 207 patients were randomized (1:1) to APR 30 mg BID or PBO BID for a 12-week PBO-controlled phase, followed by a 52-week active treatment extension. Eligible patients were >=18 years old, had active Behcet syndrome, with >=3 OU at randomization or >=2 OU at screening and randomization, and without active major organ involvement. The primary efficacy endpoint was area under the curve for the number of OU from baseline through 12 weeks (AUCWk0-12). Clinical improvement of OU was evaluated by assessments of OU pain (100 mm VAS) and measures of disease activity and QoL. Disease activity measures included the Behcet Disease Current Activity Index Form (BDCAF) and Behcet Syndrome Activity Score (BSAS). QoL assessments included the Behcet Disease QoL (BDQoL) and the 36-item Short-Form Health Survey version 2 (SF-36v2), consisting of Physical and Mental Component Summary (PCS and MCS) scores and Physical Functioning domain (PF) score. An ANCOVA model was used to analyze the primary endpoint and change from baseline in BDQoL score and SF-36v2 PCS, MCS, and PF scores.
Result(s): The primary efficacy endpoint of AUCWk0-12 for the number of OU was significantly lower in APR vs PBO patients (P <.0001). Significant improvements were observed with APR versus PBO in the mean change from baseline to Week 12 in BDQoL score (P =.0003), which was supported by significant improvements in the mean change from baseline to Week 12 in SF-36v2 PCS (P =.0204), MCS (P <.0001), and PF (P =.0060) scores in APR versus PBO patients. In all of the SF-36v2 subscale scores, a 10% to 25% greater proportion of patients receiving APR versus PBO experienced an improvement of at least 2.5 points (minimal clinically important difference) at Week 12.
Conclusion(s): APR demonstrated significant reductions in OU through Week 12 and clinically meaningful improvements in Behcet syndrome-related and overall health-related QoL, including physical and mental function.
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EMBASE:2004219191
ISSN: 0190-9622
CID: 4495992