Efficacy and safety of apremilast for 3 months in Behçet’s disease: A prospective observational study

Abstract

Objective

To determine the real-world short-term efficacy and safety of apremilast for Behçet’s disease (BD).

Methods

The study included patients who received apremilast for refractory oral ulcers in addition to meeting International Study Group criteria for BD or the revised International Criteria for Behçet’s Disease. To assess the efficacy of apremilast, Behçet’s disease current activity form (BDCAF) and patients’ self-perception of their disease activity were monitored for three months. The disease phenotypes, laboratory data, concomitant medication use, and adverse events were also investigated.

Results

Fourteen BD patients were included in the study. Concomitant drug use were as follows: colchicine 92.9%, prednisolone 21.4%, immunosuppressants 28.6%, and tumor-necrosis inhibitor 14.3%. Oral ulcers and BDCAF scores at 3 months showed significant improvement compared to baseline. Adverse events during the study were diarrhea (n = 3, 21.4%), nausea (n = 3, 21.4%), music hallucination (n = 1, 7.1%), and branch retinal vein occlusion (n = 1, 7.1%). Apremilast was discontinued in 1 patient (7.1%) due to nausea.

Conclusion

Significant improvement in oral ulcer and BDCAF with apremilast was confirmed in real-world BD patients after 3 months. The combination of colchicine and apremilast appears to be well tolerated in BD in the short-term.

Keywords:

• Behçet’s Disease
• apremilast
• oral ulcers
• BDCAF

Author contributions

YK conceived of the study, obtained data performed the statistical analysis, participated in its design and coordination, and wrote the manuscript, LH conceived of the study, obtained data, participated in data analysis, and wrote the manuscript, M Takeno conceived of the study, participated in its design and coordination, and wrote the manuscript, KTM obtained data and participated in analysis and interpretation of data, RY obtained data and participated in analysis and interpretation of data, M Takeuchi obtained data and participated in analysis and interpretation of data, NM obtained data and participated in analysis and interpretation of data, HN participated in analysis and interpretation of data. All authors read and approved the final manuscript.

Conflict of interest

YK and MT received a consultation fee from Amgen. The other authors declare no conflict of interest regarding this work.

Additional information

Funding

YK, M Takeno, M Takeuchi, NM, HN are supported by grants from Japan Society for the Promotion of Science Grant-in-Aid for Scientific Research [Grant No. 19H03700]. M Takeno, YK, MT, M Takeuchi, and NM are supported by grants from the Behçet’s Disease Research Committee, Research on Specific Disease of the Health Science Research, the Ministry of Health, Labor, and Welfare, and Japan Agency for Medical Research and Development.