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The OTEZLA® international website

This site is intended for healthcare professionals outside the U.S.

STUDY DESIGNS

OTEZLA has been studied in over 4,000 patients with psoriasis and psoriatic arthritis worldwide1
Study*
Total number of patients (N)
DMARD-naïve
Biologic-naïve
OTEZLA monotherapy
DMARD combination therapy allowed
Moderate psoriasis (systemic naïve)
Clinical trials in PsA
PALACE 1504
PALACE 2484
PALACE 3505
PALACE 4527
ACTIVE219
Clinical trials in PsO
ESTEEM 1844
ESTEEM 2411
LIBERATE250
UNVEIL221

*This table does not include the full list of clinical trials in which OTEZLA has been evaluated.

In PALACE 1-3, 76.4% of patients were biologic-naïve, as mandated by study protocol.

In psoriatic arthritis trials, combination therapy included concomitant use of one or more of the following: methotrexate, sulfasalazine, or leflunomide, low-dose oral corticosteroid and/or NSAID.

ACTIVE, Accessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients with Psoriatic Arthritis; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; LAPIS-PsA, Study of Apremilast Use in Patients with Psoriatic Arthritis in Practice Conditions; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy. LIBERATE, Evaluation from a Placebo-controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis. UNVEIL, Evaluating Apremilast in a Phase 4 Trial of Efficacy and Safety in Patients with Moderate Plaque Psoriasis.

PALACE 1-3 Study Design4

aDoses of apremilast were titrated during the first week of administration.

bPlacebo patients whose TJC and SJC had not improved by at least 20% at week 16 were re-randomized to apremilast 20 mg or 30 mg BID.

cAt week 24, all remaining placebo patients were re-randomized to apremilast 20 mg or 30 mg BID

Protocol: Randomized, double-blind, placebo-controlled studies evaluating apremilast 30 mg BID alone or in combination with DMARDS*

Patient Population: Adult patients with active PsA previously treated with 1 conventional DMARD or biologic – PALACE 3 included adult patients with a BSA of 3%

Extension phase: Pre-specified 5-year open extension safety phase

*One or more of the following: methotrexate, sulfasalazine, or leflunomide, low dose oral corticosteroid and/or NSAID.

ACR, American College of Rheumatology; BID, twice daily; BSA, body surface area; DMARD, disease-modifying antirheumatic drug; NSAID, nonsteroidal anti-inflammatory drug; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; SJC, swollen joint count; TJC, tender joint count.

PALACE 4 Study Design2

aAll doses were titrated over the first week of treatment.

bPlacebo patients with <20% reduction from baseline in swollen or tender joint counts at week 16 were required to be re-randomized to apremilast 20 mg BID or 30 mg BID. Apremilast-treated patients remained on their original dose

cAt Week 24, all remaining placebo patients were re-randomized to apremilast 20 mg BID or 30 mg BID.

Protocol: Randomized, double-blind, placebo-controlled study evaluating apremilast as monotherapy*

Patient population: Adult patients with active PsA having no prior treatment with a conventional DMARD or biologic (DMARD- and biologic naïve)

Extension phase: Prespecified 5-year open extension safety phase

*Patients received apremilast as monotherapy but were allowed to continue on stable doses of oral corticosteroids and/or NSAIDs or narcotic analgesic.

ACR, American College of Rheumatology; BID, twice daily; DMARD, disease-modifying antirheumatic drug; NSAID, nonsteroidal anti-inflammatory drug.

ACTIVE Study Design5

aAll doses were titrated over the first week of treatment.

bPatients whose swollen and tender joint count had not improved by >10% at week 16 were eligible to be switched to apremilast 30 mg BID (with dose titration) if they were initially randomized to placebo, based on investigator discretion; apremilast-treated patients remained on their assigned treatment.

cAt week 24, all remaining patients were switched to apremilast 30 mg BID (with dose titration) through week 52.

Protocol: Randomized, double-blind, placebo-controlled study evaluating apremilast as monotherapy

Patient population: Adult patients with active PsA having no prior treatment with a biologic therapy and prior treatment with a maximum of 1 DMARD

Extension phase: Mean duration of PsA was 1.4 years in the placebo controlled group and 2.3 years in the apremilast group6

ACR, American College of Rheumatology; ACTIVE, Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients with Psoriatic Arthritis; BID, twice daily; DMARD, disease-modifying antirheumatic drug; SJC, swollen joint count; TJC, tender joint count.

LAPIS-PsA Study Design7

Protocol: 52-week multicenter, prospective, non-interventional study assessing real-world use and outcomes of apremilast 30 mg BID in patients under routine care in Germany

Patient population: Adult patients with an existing diagnosis of active moderate to severe psoriatic arthritis. Indication and inclusion were according to the apremilast Summary of Product Characteristics

Interim analysis: An interim analysis was performed among the first cohort of patients having at least 4 months of follow-up data. Data obtained at baseline and Visit 2 (~4 months) were included in the analysis

BL, baseline; BID, twice daily; LAPIS-PsA, Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions; PGA, Physician Global Assessment.

References:

  1. Data on file, Celgene Corporation.
  2. Wells AF, Edwards CJ, Kivitz AJ, et al. Apremilast Monotherapy as the First Systemic Treatment in DMARD-Naïve Patients With Psoriatic Arthritis: 3-Year Treatment Results. Presented at: the Annual European Congress of Rheumatology EULAR 2016; 8–11 June 2016; London, UK.
  3. Nash P, Ohson K, Walsh J, et al. Early onset of efficacy with apremilast monotherapy in biologic-naïve patients with active psoriatic arthritis: a phase 3b randomized, controlled trial. Poster presented at: the 2016 ACR/ARHP Annual Meeting; November 12-16, 2016; Washington, DC.
  4. Kavanaugh A, Gladman DD, Edwards CJ, et al. Apremilast, an Oral Phosphodiesterase Inhibitor, Is Associated With Long-term (104-Week) in Fatigue in Patients With Psoriatic Arthritis: Pooled Results From 3 Phase 3, Randomized, Controlled Trials. Presented at: the 2015 ACR/ARHP Annual Meeting; November 7-11, 2015; San Francisco, CA.
  5. Nash P, Ohson K, Walsh J, et al. Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomized controlled trial (ACTIVE). Ann Rheumatol. 2018 Jan 17 doi:10.1136/annrheumdis-2017-211568 [Epub ahead of print].
  6. Nash P, Ohson K, Walsh J, et al. Early onset of efficacy with apremilast monotherapy in biologic-naïve patients with active psoriatic arthritis: a phase 3b randomized, controlled trial. Poster presented at: the Annual European Congress of Rheumatology EULAR 2017: 14-17 June 2017: Madrid, Spain.
  7. Wollenhaupt J, Vollmer M, Berger S, et al. Real-world insights on apremilast treatment in psoriatic arthritis patients: interim analysis of the multicenter LAPIS-PsA study. Presented at: the 45th Congress of the German Society of Rheumatology (DGRh); 6-9 September 2017; Stuttgart, Germany.
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