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Efficacy

Results from Otezla® (apremilast) clinical trials
  • ACR20 
    Response
  • Joint Swelling
  • Joint Tenderness
  • Dactylitis
  • Enthesitis
  • Physical
    Function
  • ACTIVE: Biologic Naïve

Otezla significantly improved ACR20 response, with or without DMARDs1-3

BID, twice daily; DMARDs, disease-modifying antirheumatic drugs.
  • Otezla also significantly improved ACR20 response vs placebo at week 16 in PALACE 2 and 3; nonresponder imputation intent-to-treat analysis1-3
  • ACR responses observed in the groups treated with Otezla were consistent in patients who had received either prior small-molecule or prior biologic DMARD use2

Otezla and ACR20 response through week 1042,3

DMARDs, disease-modifying antirheumatic drugs.

Includes all patients exposed to Otezla from baseline who completed treatment through week 104.

a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 104 weeks.

b

n/N, number of responders/number of subjects who had sufficient data for a definitive determination of response status at the time point, which includes subjects who discontinued early between the preceding time point and the specific time point.

  • Patients discontinued treatment during the study due to adverse events, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, non-compliance, and other)
  • Placebo-controlled efficacy data were collected and analyzed through week 24. Placebo nonresponders at week 16 were re-randomized to either 20 mg twice daily or 30 mg twice daily Otezla. At week 24, all remaining patients receiving placebo were re-randomized to either 20 mg twice daily or 30 mg twice daily. Patients treated with Otezla remained on their initial treatment1

Selected 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 have been reported 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

Otezla: joint swelling reduction through week 104 in PALACE 12,3

DMARDs, disease-modifying antirheumatic drugs.

Includes all patients exposed to Otezla from baseline who completed treatment through week 104.

a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 104 weeks.

b

Patients discontinued treatment during the study due to adverse events, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, non-compliance, and other).

c

The n at each time point represents patients with a baseline value and a post-baseline value at the time point and includes subjects who discontinued early between the preceding time point and the specific time point.

  • Treatment with Otezla also significantly improved all other measured ACR components vs placebo at week 16 — pain and global disease activity assessed by patients, global disease activity assessed by physicians, Health Assessment Questionnaire-Disability Index (HAQ-DI), and CRP (C-reactive protein)1,2

Selected Safety Information

Warnings and Precautions (cont’d)

  • Depression: 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 (0/495). 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

Otezla: joint tenderness reduction through week 104 in PALACE 12,3

DMARDs, disease-modifying antirheumatic drugs.

Includes all patients exposed to Otezla from baseline who completed treatment through week 104.

a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 104 weeks.

b

Patients discontinued treatment during the study due to adverse events, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, non-compliance, and other).

c

The n at each time point represents patients with a baseline value and a post-baseline value at the time point and includes subjects who discontinued early between the preceding time point and the specific time point.

  • Treatment with Otezla also significantly improved all other measured ACR components vs placebo at week 16 — pain and global disease activity assessed by patients, global disease activity assessed by physicians, Health Assessment Questionnaire-Disability Index (HAQ-DI), and CRP (C-reactive protein)1,2

Selected Safety Information

Warnings and Precautions (cont’d)

  • Weight Decrease: Body weight loss of 5-10% was reported in 10% of patients taking Otezla and in 3.3% of patients taking placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla

Resolution of preexisting dactylitis2

DMARDs, disease-modifying antirheumatic drugs; DSS, Dactylitis Severity Score.

Includes all patients exposed to Otezla from baseline who completed treatment through week 104.

a

A Dactylitis Severity Score of 0 indicates that all digits in the hands and feet are free of dactylitis.

b

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 104 weeks.

c

Patients discontinued treatment during the study due to adverse events, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, non-compliance, and other).

d

n/N, number of responders/number of subjects who had sufficient data for a definitive determination of response status at the time point, which includes subjects who discontinued early between the preceding time point and the specific time point.

Selected Safety Information

Warnings and Precautions (cont’d)

  • 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

Resolution of preexisting enthesitis2

DMARDs, disease-modifying antirheumatic drugs;
MASES, Maastricht Ankylosing Spondylitis Enthesitis Score.

Includes all patients exposed to Otezla from baseline who completed treatment through week 104.

a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 104 weeks.

b

A MASES score of 0 indicates the absence of pain in the 13 tested entheses.4,5

c

Patients discontinued treatment during the study due to adverse events, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, non-compliance, and other).

d

n/N, number of responders/number of subjects who had sufficient data for a definitive determination of response status at the time point, which includes subjects who discontinued early between the preceding time point and the specific time point.

Selected Safety Information

Adverse Reactions

  • 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)

Physical function response with Otezla2

DMARDs, disease-modifying antirheumatic drugs;
HAQ-DI, Health Assessment Questionnaire Disability Index.

Includes all patients exposed to Otezla from baseline who completed treatment through week 104.

a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 104 weeks.

b

Patients discontinued treatment during the study due to adverse events, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, non-compliance, and other).

c

The n at each time point represents patients with a baseline value and a post-baseline value at the time point and includes subjects who discontinued early between the preceding time point and the specific time point.

Physical function was significantly improved at week 16 with Otezla 30 mg (-0.244, n = 159) vs placebo (-0.086, n = 165); P = 0.0017. Similar results were observed in PALACE 2 and 31,2
(LOCF; full analysis set)

LOCF, last observation carried forward.

Selected Safety Information

Use in Specific Populations

  • Pregnancy and Nursing Mothers: Otezla is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when Otezla is administered to a nursing woman

Efficacy in biologic-naïve patients

ACTIVE: the primary endpoint of ACR20 response at week 16 was significantly greater with Otezla 30 mg BID (38.2%, n = 110) vs placebo (20.2%, n = 109); P = 0.0040
(nonresponder imputation; full analysis set)

a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 52 weeks.

b

Includes all patients exposed to Otezla from baseline who completed treatment through week 52.

c

At week 16, patients receiving placebo were eligible to be switched to Otezla; at week 24, all remaining patients receiving placebo were switched to Otezla. Only patients who received ≥1 dose of Otezla were included.

d

n/N, number of responders/number of subjects who had sufficient data for a definitive determination of response status at the time point, which includes subjects who discontinued early between the preceding time point and the specific time point.

  • Statistical significance was not reached for the first secondary endpoint. Hierarchical testing was therefore stopped, making the remaining secondary endpoints statistically nonsignificant2
  • See study design below for more information
a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 52 weeks.

b

Includes all patients exposed to Otezla from baseline who completed treatment through week 52.

c

At week 16, patients receiving placebo were eligible to be switched to Otezla; at week 24, all remaining patients receiving placebo were switched to Otezla. Only patients who received ≥1 dose of Otezla were included.

d

The n at each time point represents patients with a baseline value and a post-baseline value at the time point and includes subjects who discontinued early between the preceding time point and the specific time point.

a

Data are presented "as observed" with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 52 weeks.

b

Includes all patients exposed to Otezla from baseline who completed treatment through week 52.

c

At week 16, patients receiving placebo were eligible to be switched to Otezla; at week 24, all remaining patients receiving placebo were switched to Otezla. Only patients who received ≥1 dose of Otezla were included.

d

The n at each time point represents patients with a baseline value and a post-baseline value at the time point and includes subjects who discontinued early between the preceding time point and the specific time point.

  • A global phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating apremilast monotherapy in patients with active psoriatic arthritis for up to 104 weeks
  • Patients were randomized 1:1 to either Otezla 30 mg (n = 110) twice daily, or placebo (n = 109) through week 24. At week 24, all patients crossed over to the Otezla arm (with dose titration) through week 52; open-label treatment phase from weeks 52 to 104
  • Selected inclusion criteria: age ≥18 years; diagnosis of psoriatic arthritis for at least 3 months at baseline; at least 3 swollen and tender joints; no prior exposure to a biologic; may have had treatment with 1 prior conventional disease-modifying antirheumatic drug (DMARD) [no requirement for DMARD washout, except for a 4-week washout for cyclosporine and 12-week washout for leflunomide]
  • Primary endpoint: proportion of patients on Otezla who achieved ACR20 at week 16
  • Statistical significance was not reached for the first secondary endpoint. Hierarchical testing was therefore stopped, making the remaining secondary endpoints statistically nonsignificant2
  • The most common adverse reactions (reported in ≥5% of subjects) during the apremilast exposure period (N = 206) included diarrhea (16.5%); nausea (8.7%); nasopharyngitis (8.3%); headache (6.3%); hypertension (6.3%); upper respiratory tract infection (8.3%); bronchitis (5.3%)2
  • Adverse reactions leading to discontinuation during the apremilast exposure period (N = 206) included: diarrhea (2.9%); depression (1.5%); nausea (1.0%); vomiting (1.0%)2

Selected Safety Information

Use in Specific Populations

  • 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

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Data on file, Celgene Corporation. 3. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. J Rheumatol. 2015;42(3):479-488. 4. Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A, et al. Ann Rheum Dis. 2003;62(2):127-132. 5. Marchesoni A, Cantini F. Reumatismo. 2012;64(2):79-87.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

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Reference: 1. Data on file, Celgene Corporation.
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