Oral Ulcers in Behçet's Disease

RELIEF Study Design

Otezla® (apremilast) was evaluated in 207 adult patients with BD with active oral ulcers1,2

RELIEF study design1,3

BID, twice daily. RELIEF, Researching Oral Apremilast Safety and Efficacy in Behçet's Disease.

Baseline demographics and disease characteristics were balanced between study arms, with a mean duration of BD diagnosis 6.8 years; mean oral ulcer count of 4.2 (Otezla) and 3.9 (placebo).1,3

Clinical study1-3

Study design:

  • RELIEF: Multicenter, randomized, double-blind, placebo-controlled phase 3 study
  • 207 adult patients with BD with active oral ulcers
  • Randomized 1:1 to either Otezla 30 mg twice daily (n = 104) or placebo (n = 103) for 12 weeks
  • Doses were titrated for the first 5 days
  • After week 12, all patients received Otezla 30 mg twice daily for the 52-week active treatment phase

Measures of oral ulcers:

  • Change from baseline in the pain of oral ulcers as measured by VAS at week 12
  • Proportion of patients achieving oral ulcer complete response (oral ulcer–free) at week 12
  • Proportion of patients achieving oral ulcer complete response (oral ulcer–free) by week 6 and who remained oral ulcer–free for at least 6 additional weeks during the 12-week placebo-controlled treatment phase
  • Daily average number of oral ulcers during the 12-week placebo-controlled treatment phase

Selected inclusion criteria:

  • Met the International Study Group (ISG) criteria for BD
  • ≥2 oral ulcers at screening and at least 2 oral ulcers at randomization, and without currently active major organ involvement
  • Oral ulcers that occurred ≥3 times in the previous 12 months prior to randomization
  • Candidates for systemic therapy
  • Prior treatment with at least 1 non-biologic BD therapy, such as immunosuppressants, colchicine, oral or topical corticosteroids, or nonsteroidal anti-inflammatory drugs. Previous exposure to biologic therapies was permitted for manifestations other than oral ulcers
  • Patients with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy were allowed

Selected exclusion criteria:

  • BD-related active major organ involvement
  • Topical corticosteroids, colchicine, immunosuppressants, and biologics were not allowed during the placebo-controlled period

Baseline disease characteristics and patient demographics1,3

Disease characteristics:

  • Mean duration: 6.84 years
  • All patients had a history of recurrent oral ulcers that were currently active
    • Baseline oral ulcer counts (Otezla: 4.2; placebo: 3.9)
  • Patients also had a history of:
    • Skin lesions (98.6%)
    • Genital ulcers (90.3%)
    • Musculoskeletal manifestations (72.5%)
    • Ocular manifestations (17.4%)
    • Central nervous system (9.7%)
    • Gastrointestinal manifestations (9.2%)
    • Vascular involvement (1.4%)

Mean age:

  • 40 years (19-72 years)

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Hatemi G, Mahr A, Ishigatsubo Y, et al. Trial of Apremilast for oral ulcers in Behçet’s Syndrome. N Engl J Med. 2019; 381:1918-1928.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

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