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Ann Rheum Dis. 2018 May;77(5):690-698. doi: 10.1136/annrheumdis-2017-211568. Epub 2018 Jan 17.

Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE).

Author information

1
Department of Medicine, University of Queensland, Brisbane, Queensland, Australia.
2
Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.
3
Department of Internal Medicine, Division of Rheumatology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
4
Celgene Corporation, Summit, New Jersey, USA.
5
Hospital Clínico Universitario, Santiago, Spain.
6
West Tennessee Research Institute, Jackson, Tennessee, USA.

Abstract

OBJECTIVE:

Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA.

METHODS:

Patients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52.

RESULTS:

Among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast's safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0-24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo).

CONCLUSIONS:

In biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports.

TRIAL REGISTRATION NUMBER:

NCT01925768; Results.

KEYWORDS:

Das28; disease activity; psoriatic arthritis; spondyloarthritis; treatment

PMID:
29343507
PMCID:
PMC5909747
DOI:
10.1136/annrheumdis-2017-211568
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: PN has received grant/research support and honoraria from Celgene Corporation. KO has received grant/research support from Celgene Corporation. JW has received non-financial support from Amgen Inc, Pfizer and UCB and has received personal fees from Celgene Corporation and Novartis. ND, DN and LT are employees of Celgene Corporation. JJG-R has received grant/research support from Roche and Schering-Plough and has served as a consultant to Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough and UCB. JAA has received grant/research support from AbbVie Inc, Ardea Biosciences, Inc, AstraZeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galápagos, Genentech Inc, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly and Company, Merck & Co, Mesoblast, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, Takeda Pharmaceuticals, UCB and Vertex Pharmaceuticals.

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