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Oral Ulcers in Behçet's Disease

Efficacy

Results from the RELIEF clinical trial with Otezla® (apremilast)1,2

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  • Clinical Response of Oral Ulcers
  • Oral Ulcers: Pain Results
  • Oral Ulcers: Complete Response
  • Oral Ulcers: Maintenance of Response
  • Oral Ulcers: Daily Average

Improvements in Measures of Oral Ulcers at Week 121-3

RELIEF: Clinical response of oral ulcers at week 12 (ITT population)1,3

 
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 12c22%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)
a

Otezla® (apremilast) — Placebo.

b

Mean changes from baseline are least-squares 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.

c

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

d

Adjusted 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.

e

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

f

Based 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.

Otezla significantly reduced oral ulcer pain at week 121,3

RELIEF: Mean change from baseline in the pain of oral ulcers as measured by VAS at week 12
(ITT population)1,a,b

Statistically significant treatment difference: -24.1c (95% CI, -32.4 to -15.7).

a

Mean changes from baseline are least-squares means from mixed-effects model for repeated measures, adjusting for sex, region, and baseline pain of oral ulcers as measured by the VAS.

b

VAS: 0=no pain, 100=worst possible pain.

c

Otezla® (apremilast) – Placebo.


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

Mean oral ulcer pain by time point through week 121,3

RELIEF: Mean (± SE) oral ulcer pain on a VAS by time point through week 12 (ITT population)1,2,a

Post hoc analysis.

a

Oral ulcer pain was assessed on a 100-mm VAS with 0 = no pain and 100 = worst possible pain. Mean baseline VAS pain scores were 61.2 and 60.8 in the Otezla® (apremilast) 30 mg twice daily treatment group and placebo treatment group, respectively.


SE, standard error.

More than 50% of patients were oral ulcer–free at week 121,3

RELIEF: Oral ulcer complete response (oral ulcer–free) rates at week 12
(ITT population)1,a

Statistically significant treatment difference: 31%b,c (95% CI, 18% to 43%).

a

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

b

Adjusted 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.

c

Otezla® (apremilast) – Placebo.


BID, twice daily; CI, confidence interval; ITT, intent-to-treat.

Maintenance of oral ulcer complete response

Significantly more patients achieved complete response by week 6 and remained oral ulcer–free for at least 6 additional weeks during the
12-week phase1,3

RELIEF: Proportion of patients achieving complete response of oral ulcers by week 6 and remaining oral ulcer-free for at least 6 additional weeks during the 12-week placebo-controlled treatment phase (ITT population)1,3,a

Statistically significant treatment difference: 25%b,c (95% CI, 16% to 35%).

a

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

b

Otezla® (apremilast) – Placebo.

c

Adjusted 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.


BID, twice daily; CI, confidence interval; ITT, intent-to-treat.

Significantly fewer oral ulcers with Otezla over 12 weeks1*

RELIEF: Daily average number of oral ulcers during the 12-week placebo-controlled treatment phase1,a,b

Statistically significant treatment difference: -1.1c (95% CI, -1.6 to -0.7).

*Daily average number of oral ulcers.
a

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

b

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

c

Otezla® (apremilast) – Placebo.


BID, twice daily; CI, confidence interval.

 

Mean number of oral ulcers by time point through week 121-3

RELIEF: Mean (± SE) number of oral ulcers by time point through week 12 (ITT population)1-3

Post hoc analysis.

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

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