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

Nash, Peter, Ohson, Kamal, Walsh, Jessica, Delev, Nikolay, Nguyen, Dianne, Teng, Lichen, Gómez-Reino, Juan J, Aelion, Jacob A and ACTIVE investigators (2018) Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). Annals of Rheumatic Diseases, 77 5: 690-698. doi:10.1136/annrheumdis-2017-211568


Author Nash, Peter
Ohson, Kamal
Walsh, Jessica
Delev, Nikolay
Nguyen, Dianne
Teng, Lichen
Gómez-Reino, Juan J
Aelion, Jacob A
ACTIVE investigators
Title Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE)
Journal name Annals of Rheumatic Diseases   Check publisher's open access policy
ISSN 1468-2060
0003-4967
Publication date 2018-01-17
Year available 2018
Sub-type Article (original research)
DOI 10.1136/annrheumdis-2017-211568
Open Access Status PMC
Volume 77
Issue 5
Start page 690
End page 698
Total pages 10
Place of publication London, United Kingdom
Publisher B M J Group
Language eng
Subject 2745 Rheumatology
2723 Immunology and Allergy
2403 Immunology
1300 Biochemistry, Genetics and Molecular Biology
Abstract Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA.

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.

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).

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.

NCT01925768; Results.
Keyword Das28
Disease activity
Psoriatic arthritis
Spondyloarthritis
Treatment
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Medicine Publications
 
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Created: Wed, 24 Jan 2018, 12:13:15 EST