Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1)

Papp, Kim; Reich, Kristian; Leonardi, Craig L.; Kircik, Leon; Chimenti, Sergio; Langley, Richard; Hu, C.; Stevens, R.; Day, Robert M.; Gordon, Kenneth B.; Korman, Neil J.; Griffiths, C.E.M.

doi:10.1016/j.jaad.2015.03.049

Cited by 530 publications

(648 citation statements)

References 12 publications

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“…Improved QOL may help motivate patients to maintain treatment over time, which may lead to better disease control. The safety profile of apremilast during the apremilast‐extension phase was consistent with the ESTEEM and PALACE trials 2, 3, 4, 5, 6, 7…”

Section: Discussionsupporting

confidence: 74%

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

Reich

Gooderham

Bewley

et al. 2018

Acad Dermatol Venereol

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BackgroundApremilast, an oral phosphodiesterase‐4 inhibitor, has demonstrated efficacy in patients with moderate to severe psoriasis.ObjectiveTo 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.MethodsTwo 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).ResultsThe 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‐observation‐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 −48.1% to −51.1%; DLQI score ≤5 was achieved by 66.0%–72.5% of patients; and pruritus VAS mean change from baseline was −24.4 to −32.3. AEs in ≥5% of patients (diarrhoea, nausea, nasopharyngitis, upper respiratory tract infection and headache) did not increase with prolonged apremilast exposure.ConclusionsApremilast 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.

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Section: Discussionsupporting

confidence: 74%

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

Reich

Gooderham

Bewley

et al. 2018

Acad Dermatol Venereol

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“…After 16 weeks of treatment, 33.1% of patients treated with apremilast and 5.3% of those receiving placebo achieved PASI 75 [65].…”

Section: Apremilastmentioning

confidence: 99%

Biological therapies in psoriasis - revisited

Sârbu

Georgescu

Tampa

et al. 2018

Romanian Journal of Internal Medicine

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Psoriasis is a chronic, immune mediated disorder affecting approximately 2% of the population. Even in our days, patients with psoriasis are confronted with stigmatization and social rejection. As a result, their quality of life is significantly impaired. Biological therapies have revolutionized the treatment of moderate to severe psoriasis. The aim of this paper is to look over the most important biological therapies available for the management of plaque-type psoriasis.

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“…This response was sustained in 47 of these patients. 2 There were four main trials of apremilast in psoriatic arthritis. They had similar designs with 24 weeks of placebo-controlled treatment followed by at least 28 weeks of active treatment for all patients and then an open-label safety phase.…”

Section: New Drugsmentioning

confidence: 99%

“…[1][2][3] In general, patients were heavily pre-treated (2−4 previous therapies) and their median ages were 66−68 years. Patients taking warfarin were excluded.…”

Section: New Drugsmentioning

confidence: 99%

New drugs: Apremilast

2015

Aust Prescr

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Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1)

Abstract: Apremilast was effective in moderate to severe plaque psoriasis.

Cited by 530 publications

References 12 publications

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

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

Biological therapies in psoriasis - revisited

New drugs: Apremilast

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