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Oral Ulcers in Behçet's Disease
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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,f2.6 | 1.5 | -1.1 (-1.6, -0.7) |
aOtezla® (apremilast) — Placebo. bMean 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. 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.
CI, confidence interval; ITT, intent-to-treat; LS, least squares.
Statistically significant treatment difference: -24.1c (95% CI, -32.4 to -15.7).
aVAS: 0=no pain, 100=worst possible pain. bMean 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 VAS. cOtezla – Placebo.
BID, twice daily; LS, least squares.
(ITT population; post-hoc analysis; data as observed)3a
aResults from the post-hoc analysis are exploratory and conclusions cannot be made. bData are presented “as observed” with no imputation for missing values. cPatients entered a 4-week post-treatment observational follow-up phase following discontinuation of Otezla at or before week 64.
SE, standard error.
Statistically significant treatment differencec,d: (95% CI) = 31% (18%,43%)
aComplete response is defined as oral ulcer-free. bPatients for whom data are not available to determine response status are considered nonresponders. cAdjusted 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. dOtezla – Placebo.
aResults from the post-hoc analysis are exploratory and conclusions cannot be made. bData are presented “as observed” with no imputation for missing values. cPatients entered a 4-week post-treatment observational follow-up phase following discontinuation of Otezla® (apremilast) at or before week 64.
SE, standard error.
Maintenance of oral ulcer complete response
Statistically significant treatment differenced,e: (95% CI) = 25% (16%, 35%)
aDuring the 12-week placebo-controlled treatment phase. bPatients for whom data are not available to determine response status are considered nonresponders. cComplete response is defined as the proportion of patients who are oral ulcer-free. 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. eOtezla – Placebo.
BID, twice daily; CI, confidence interval; ITT, intent-to-treat.
Statistically significant treatment differencec: (95% CI) = -1.1 (-1.6, -0.7)
aMean daily averages are least-squares means from analysis of covariance, after adjusting for sex, region, and baseline number of oral ulcers. bBased on oral ulcer counts measured at baseline and at weeks 1, 2, 4, 6, 8, 10, and 12. cOtezla® (apremilast) – Placebo.
BID, twice daily; CI, confidence interval.
ITT population; post-hoc analysis; data as observed3,a,b
aResults from the post-hoc analysis are exploratory and conclusions cannot be made. bData are presented “as observed” with no imputation for missing values. cPatients entered a 4-week post-treatment observational follow-up phase following discontinuation of Otezla at or before week 64.
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.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. 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. 3. Data on file, Amgen Inc.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. 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. 3. Data on file, Amgen Inc.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. 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.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. 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. 3. Data on file, Amgen Inc.
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.