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 phasec | 5% | 30% | 25%d (16%, 35%) |
| Daily average number of oral ulcers during the 12-week placebo-controlled treatment phasee,f | 2.6 | 1.5 | -1.1 (-1.6, -0.7) |
Otezla® (apremilast) — Placebo.
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.
Patients for whom data are not available to determine response status are considered nonresponders.
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.
Mean daily averages are least squares means from analysis of covariance, after adjusting for sex, region, and baseline number of oral ulcers.
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.
Statistically significant treatment difference: -24.1c (95% CI, -32.4 to -15.7).
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.
VAS: 0=no pain, 100=worst possible pain.
Otezla® (apremilast) – Placebo.
BID, twice daily; CI, confidence interval; ITT, intent-to-treat; VAS, visual analog scale.
Post hoc analysis.
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.
Statistically significant treatment difference: 31%b,c (95% CI, 18% to 43%).
Patients for whom data are not available to determine response status are considered nonresponders.
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.
Otezla® (apremilast) – Placebo.
BID, twice daily; CI, confidence interval; ITT, intent-to-treat.
Maintenance of oral ulcer complete response
Statistically significant treatment difference: 25%b,c (95% CI, 16% to 35%).
Patients for whom data are not available to determine response status are considered nonresponders.
Otezla® (apremilast) – Placebo.
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.
Statistically significant treatment difference: -1.1c (95% CI, -1.6 to -0.7).
*Daily average number of oral ulcers.Mean daily averages are least-squares means from analysis of covariance, after adjusting for sex, region, and baseline number of oral ulcers.
Based on oral ulcer counts measured at baseline and at weeks 1, 2, 4, 6, 8, 10, and 12.
Otezla® (apremilast) – Placebo.
BID, twice daily; CI, confidence interval.
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.
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