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Efficacy

The proven efficacy of Otezla® (apremilast).
  • ACR20
    Response
  • Joint Tenderness
    And Swelling
  • Dactylitis and
    Enthesitis
  • Physical
    Function

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

  • Otezla® (apremilast) also significantly improved ACR20 response vs placebo at week 16 in Studies 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

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.

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

Warnings and Precautions

  • Depression: Treatment with Otezla is associated with an increase in adverse reactions of depression. During clinical trials, 1.0% (10/998) of patients treated with Otezla reported depression or depressed mood compared to 0.8% (4/495) treated with placebo; 0.3% (4/1441) of patients treated with Otezla discontinued treatment due to depression or depressed mood compared with none in placebo treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo treated patients (0/495). Suicidal ideation and behavior were observed in 0.2% (3/1441) of patients on Otezla, compared to none on placebo (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • 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 and swelling reduction through week 104 in Study 12,3

Median percent reduction (prespecified analysis; data as observed)2,a

TENDER JOINTS

SWOLLEN JOINTS

N = 168, ITT

Otezla 30 mg twice daily ± DMARDs

DMARDs, disease-modifying antirheumatic drugs; ITT, intent-to-treat.

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.

  • Treatment with Otezla® (apremilast) 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
  • 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 (eg, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Reduction of preexisting dactylitis and enthesitis2,3

Reduction in Dactylitis Severity Score to a count of zero in Studies 1-32,a,b

Reduction in MASES to a score of zero in Studies 1-32,b,c

Otezla 30 mg twice daily ± DMARDs

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

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

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

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

N = 497, ITT

Otezla 30 mg twice daily ± DMARDs

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

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


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 Studies 2 and 31,2

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
  • 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; 2015. 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.

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Indications & Important Safety Information

Please click here for Full Prescribing Information.

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