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The FDA approves new data for Otezla® (apremilast) Learn more about this treatment option for your patients
EXPLORE

Oral Ulcers in Behçet's Disease

Efficacy

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

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Improvements in Measures of Oral Ulcers at Week 121

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 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)
 

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.

Otezla significantly reduced oral ulcer pain at week 121,2

RELIEF: Change from baseline in the pain of oral ulcers as measured by VAS scores at week 12
(ITT population)1,2,a,b

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.


MEAN CHANGE IN ORAL ULCER PAIN THROUGH WEEK 643

RELIEF: Mean change (± SE) in oral ulcer pain VAS by timepoint through week 64

(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.

PLACEBO-
CONTROLLED PHASE3
Patients initiated on placebo were switched to Otezla 30 mg BID at week 12
ACTIVE
TREATMENT3
All patients in both arms received Otezla 30 mg BID at week 12 through week 64
POST-TREATMENT
OBSERVATIONAL FOLLOW-UP3
Patients entered a 4-week post-treatment observational follow-up period following discontinuation of Otezla at or before week 64

More than 50% of patients were oral ulcer-free at week 121,2

RELIEF: Oral ulcer complete response (oral ulcer-free) rates at week 12
(ITT population)1,2,a,b

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.


Oral ulcer complete response rate through week 643

RELIEF: Oral ulcer complete response rate by timepoint through week 64
(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® (apremilast) at or before week 64.

 


SE, standard error.

PLACEBO-
CONTROLLED PHASE3
Patients initiated on placebo were switched to Otezla 30 mg BID at week 12
ACTIVE
TREATMENT3
All patients in both arms received Otezla 30 mg BID at week 12 through week 64
POST-TREATMENT
OBSERVATIONAL FOLLOW-UP3
Patients entered a 4-week post-treatment observational follow-up period following discontinuation of Otezla at or before week 64

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 phase1,2

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)1,2,a-c

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.

Significantly fewer oral ulcers with Otezla over 12 weeks1,2

RELIEF: Daily average number of oral ulcers during the 12-week placebo-controlled treatment phase (ITT population)1,2,a,b

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.

 

Mean number of oral ulcers by time point through week 643

RELIEF: Mean (± SE) number of oral ulcers by time point through week 64

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.

PLACEBO-
CONTROLLED PHASE3
Patients initiated on placebo were switched to Otezla 30 mg BID at week 12
ACTIVE
TREATMENT3
All patients in both arms received Otezla 30 mg BID at week 12 through week 64
POST-TREATMENT
OBSERVATIONAL FOLLOW-UP3
Patients entered a 4-week post-treatment observational follow-up period 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.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

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.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
  • Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

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.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1%(1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
  • Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.