Safety and efﬁcacy of apremilast through 104 weeks in
patients with moderate to severe psoriasis who continued
on apremilast or switched from etanercept treatment:
ﬁndings from the LIBERATE study
* M. Gooderham,
, V. Piguet
Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany
SKiN Centre for Dermatology, Queen’s University and Probity Medical Research, Peterborough, Ontario, Canada
Whipps Cross University Hospital, London, UK
The Royal London Hospital, London, UK
George Washington University School of Medicine, Washington, DC, USA
Southern California Dermatology, Santa Ana, CA, USA
Celgene Corporation, Summit, NJ, USA
Cardiff University and University Hospital of Wales, Wales, UK
Division of Dermatology, Women’s College Hospital, Toronto, Ontario, Canada
Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada
*Correspondence: K. Reich. E-mail: email@example.com
Background Apremilast, an oral phosphodiesterase-4 inhibitor, has demonstrated efﬁcacy in patients with moderate
to severe psoriasis.
Objective To evaluate long-term efﬁcacy and safety of apremilast in biologic-naive patients with moderate to severe
plaque psoriasis and safety of switching from etanercept to apremilast in the phase 3b LIBERATE trial.
Methods Two hundred ﬁfty patients were randomized to placebo, apremilast 30 mg BID or etanercept 50 mg QW
through Week 16; thereafter, all patients continued or switched to apremilast through Week 104 (extension phase). Skin,
scalp and nail involvement at Weeks 16, 52 and 104 were assessed using the Psoriasis Area and Severity Index (PASI;
0–72), Scalp Physician Global Assessment (ScPGA; 0–5) and Nail Psoriasis Severity Index (NAPSI; 0–8); patient-reported
outcomes (PROs) were assessed using the Dermatology Life Quality Index (DLQI; 0–32) and pruritus visual analog scale
(VAS; 0–100 mm).
Results The apremilast-extension phase (Weeks 16–104) included 226 patients in the placebo/apremilast (n = 73),
apremilast/apremilast (n = 74) and etanercept/apremilast (n = 79) groups, and at Week 104, 50.7%, 45.9% and
51.9% of these patients, respectively, maintained ≥75% reduction from baseline in PASI score (based on last-obser-
vation-carried-forward analysis). Across treatment groups, ScPGA 0 (clear) or 1 (minimal) was achieved by 50.0%–
59.2% of patients; NAPSI mean change from baseline was À48.1% to À51.1%; DLQI score ≤5 was achieved by
66.0%–72.5% of patients; and pruritus VAS mean change from baseline was À24.4 to À32.3. AEs in ≥5% of patients
(diarrhoea, nausea, nasopharyngitis, upper respiratory tract infection and headache) did not increase with prolonged
Conclusions Apremilast demonstrated signiﬁcant and sustained improvements in skin, scalp, nails and PROs (pruritus
and quality of life) over 104 weeks in patients with moderate to severe plaque psoriasis. Safety was consistent with the
known safety proﬁle of apremilast.
Received: 8 September 2017; Accepted: 22 November 2017
Conﬂicts of interest
K. Reich has received honoraria as a consultant and/or advisory board member and/or acted as a paid speaker
and/or participated in clinical trials sponsored by AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene
Corporation, Centocor, Covagen, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma,
Medac, Merck Sharp & Dohme Corp., Novartis, Ocean Pharma, Pﬁzer, Regeneron, Takeda, UCB Pharma and
© 2017 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd
on behalf of European Academy of Dermatology and Venereology.
2018, 32, 397–402
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