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Otezla® (apremilast) is also indicated for
moderate to severe plaque psoriasis and
psoriatic arthritis

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Otezla is the first and only systemic therapy approved for
oral ulcers associated with
Behçet’s Disease1

Behçet's Disease (BD), also referred to as Behçet's Syndrome, is a rare, chronic, multisystem inflammatory disorder. The most common manifestation is oral ulcers.2,3 For patients with oral ulcers associated with Behçet's Disease, Otezla® (apremilast) may be an option.

RELIEF™ study design

Clinical trial program1,4

  • RELIEF: Multicenter, double-blind, randomized, placebo-controlled, parallel-group, phase 3 study
  • 207 adult patients with BD with active oral ulcers
  • Previously treated with at least one nonbiologic BD medication and were candidates for systemic therapy
  • Patients with BD-related major organ involvement were excluded from the study
  • Click here to see full study design for more information

IMPROVEMENTS IN MEASURES OF ORAL ULCERS AT WEEK 12

RELIEF: Clinical response of oral ulcers at week 12 (ITT population)1

 
Placebo(N = 103)
Otezla 30 mg BID (N = 104)
Treatment Differencea(95% CI)
Change from baseline in the pain
of oral ulcers as measured by VAS
scores at week 12b
-18.7-42.7-24.1 (-32.4, -15.7)
Proportion of patients achieving
oral ulcer complete response rate
(oral ulcer–free) at week 12c
22%53%31%d (18%, 43%)
Proportion of patients achieving oral ulcer complete response by week 6 and who remained oral ulcer–free for at least 6 additional weeks during the 12-week placebo-controlled treatment phasec5%30%25%d (16%, 35%)
Daily average number of oral ulcers during the 12-week placebo-controlled treatment phasee,f 2.61.5-1.1 (-1.6, -0.7)

aOtezla – Placebo.

bMean changes from baseline are least square means from mixed-effects model for repeated measures, adjusting for sex, region, and baseline pain of oral ulcers as measured by the VAS; 0 = no pain, 100 = worst possible pain.

cPatients for whom data are not available to determine response status are considered nonresponders.

dAdjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the Cochran-Mantel-Haenszel weights.

eMean daily averages are least squares means from analysis of covariance, after adjusting for sex, region, and baseline number of oral ulcers.

fBased on oral ulcer counts measured at baseline and at weeks 1, 2, 4, 6, 8, 10, and 12.

BID, twice daily; CI, confidence interval; ITT, intent-to-treat; VAS, visual analog scale.

The RELIEF™ clinical trial program

RELIEF study design1,4

Asset 1Double-blind, Placebo-controlled Treatment12 Weeks2ActiveTreatment52 WeeksPost-treatmentObservational Follow-up4 WeeksOtezla 30 mg BIDn = 104 Otezla 30 mg BID Placebon = 103 Otezla 30 mg BIDSCREENWeek 12Clinical response of oral ulcersWeek0Week12Week68Week64RANDOMIZE1:1

Baseline demographics and disease characteristics were balanced between study arms, with a mean duration of BD diagnosis of 6.8 years; a mean oral ulcer count of 4.2 (Otezla) and 3.9 (placebo).1,4

Clinical trial program1,4

Program:
  • RELIEF: multicenter, randomized, double-blind, placebo-controlled phase 3 study
  • 207 adult patients with BD with active oral ulcers
Study design:
  • Randomized 1:1 to either Otezla® (apremilast) 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 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 ≥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 ≥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 demographics1,4

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)

RELIEF: Adverse reactions through week 121

Adverse reactions reported in ≥5% of patients on Otezla 30 mg twice daily and with at least 1%
greater frequency than patients on placebo up to week 121

 
Placebo(N = 103)
n (%)
Otezla 30 mg BID (N = 104)
n (%)
Diarrheaa21 (20.4)43 (41.3)
Nauseaa11 (10.7)20 (19.2)
Headache11 (10.7)15 (14.4)
Upper respiratory tract infection5 (4.9)12 (11.5)
Abdominal pain upper2 (1.9)9 (8.7)
Vomitinga2 (1.9)9 (8.7)
Back pain6 (5.8)8 (7.7)
Viral upper respiratory tract infection5 (4.9)7 (6.7)
Arthralgia3 (2.9)6 (5.8)

aThere were no serious adverse reactions of diarrhea, nausea, or vomiting.

  • The most commonly reported adverse reactions (≥10%) for Otezla include diarrhea, nausea, headache, and upper respiratory tract infection
  • Discontinuation of treatment due to adverse reactions during the placebo-controlled period of the study was 2.9% for patients taking Otezla and 4.9% for placebo

The Full Prescribing Information for Otezla
has no requirement for routine lab monitoring1

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Leonardo NM, McNeil J. Int J Rheumatol. 2015:2015:945262. 3. Zeidan MJ, Saadoun D, Garrido M, et al. Autoimmun Highlights. 2016:7(1):4. 4. Data on file, Celgene Corporation.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

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