THU0413 Apremilast, An Oral Phosphodiesterase 4 Inhibitor: Improvements in Nail and Scalp Psoriasis and Psoriasis Area and Severity Index in Patients with Moderate to Severe Plaque Psoriasis (Esteem 1 and 2)
Authors: K. Papp, J. Crowley, C. Paul, M. Gooderham, K. Reich, C. Hu, R. Day, C. Griffiths
Journal: Annals of the Rheumatic Diseases (2015)

<h3>Background</h3> Many patients with psoriasis and with psoriatic arthritis have nail and scalp psoriasis, which can lead to impaired quality of life. ESTEEM 1 and 2 are phase 3, randomised, controlled trials evaluating the efficacy and safety of apremilast (APR), including improvements in nail and scalp disease, in patients with moderate to severe plaque psoriasis. <h3>Objectives</h3> Evaluate the efficacy and safety of APR in patients with moderate to severe plaque psoriasis, including difficult-to-treat manifestations of nail and scalp psoriasis <h3>Methods</h3> Patients (PASI ≥12, BSA ≥10%, sPGA ≥3) were randomised (2:1) to APR 30 mg BID (APR30) or placebo (PBO). At Week 16, PBO patients were switched to APR30 through Week 32, followed by a randomised treatment withdrawal phase up to 52 weeks. Improvements in nail and scalp psoriasis are reported up to Week 32; mean percent improvement from baseline in PASI is reported up to 52 weeks. <h3>Results</h3> The full analysis set included 844 patients (ESTEEM 1: PBO n=282; APR30 n=562) and 411 patients (ESTEEM 2: PBO n=137; APR30 n=274). In ESTEEM 1 and 2, respectively, PASI-75 achievement at Week 16 (primary end point) was 33.1% and 28.8% with APR30 vs. 5.3% and 5.8% with PBO (both <i>P</i>&lt;0.0001). In ESTEEM 1 and 2, respectively, 66.1% and 64.7% of patients had nail psoriasis (NAPSI ≥1) and 66.7% and 65.5% had moderate to very severe scalp psoriasis (ScPGA ≥3) at baseline. In patients with nail psoriasis at baseline, APR30 improved nail psoriasis at Week 16 (Table), and ≥50% improvement from baseline NAPSI (NAPSI-50) achievement was significantly greater with APR30 vs. PBO. At Week 32, NAPSI improvements continued for patients who received APR30 from baseline. In patients with ScPGA ≥3 at baseline, ScPGA of 0 (clear) or 1 (minimal) achievement at Week 16 was significantly greater with APR30 vs. PBO in ESTEEM 1 and ESTEEM 2; at Week 32, ScPGA 0 or 1 achievement was generally maintained in patients who received APR30 from baseline (Table). In ESTEEM 1 and 2, respectively, mean percent improvements in PASI at Week 2 were -22.3% and -24.3% with APR30 vs. -6.5% and -7.5% with PBO. Mean percent improvement in PASI at Week 16 was sustained through Week 32 for patients treated with APR30 from baseline (Table); at 52 weeks, improvement in PASI was -80.5% (ESTEEM 1) and -74.4% (ESTEEM 2). In patients who received APR30 from baseline and achieved PASI-75 (ESTEEM 1) or PASI-50 (ESTEEM 2) at Week 32, NAPSI-50/ScPGA 0 or 1 responses were achieved by 63.0%/72.9% and 63.2%/54.1%, respectively, at Week 32. AEs occurring in ≥5% of patients were diarrhoea, nausea, URTI, nasopharyngitis, tension headache, and headache. Most AEs were mild or moderate in severity, with no increase in incidence or severity with up to 52 weeks of treatment. <h3>Conclusions</h3> APR30 was effective and generally well tolerated for moderate to severe plaque psoriasis, including nail and scalp psoriasis, in ESTEEM 1 and 2. Mean PASI improvements were generally maintained up to 52 weeks in patients receiving APR30 from baseline. <h3>Disclosure of Interest</h3> K. Papp Grant/research support from: Abbott, Amgen, Celgene, Eli Lilly, and Janssen, Consultant for: Abbott, Amgen, Celgene, Eli Lilly, and Janssen, J. Crowley Consultant for: AbbVie, Amgen, and Celgene, Paid instructor for: AbbVie, Amgen, AstraZeneca, Celgene, Janssen, Merck, Pfizer, and Regeneron, Speakers bureau: AbbVie, C. Paul Consultant for: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, and Pfizer, M. Gooderham Paid instructor for: AbbVie, Allergan, Celgene, Eli Lilly, Galderma, Kythera, Leo Pharma, Merck, Novartis, and Pfizer, Speakers bureau: AbbVie, Amgen, Astellas, Galderma, Janssen, Leo Pharma, Novartis, and Pfizer, K. Reich Grant/research support from: Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, Schering-Plough), Novartis, Ocean Pharma, Pfizer (Wyeth), and UCB, Consultant for: Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, Schering-Plough), Novartis, Ocean Pharma, Pfizer (Wyeth), and UCB, Speakers bureau: Abbott, AbbVie, Amgen, Basilea, Biogen-Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, MSD (Essex Pharma, Schering-Plough), Novartis, Ocean Pharma, Pfizer (Wyeth), and UCB, C. Hu Employee of: Celgene Corp, R. Day Employee of: Celgene Corp, C. Griffiths Grant/research support from: Abbott, Celgene, Eli Lilly, Janssen, LEO, Novartis, and Pfizer, Consultant for: Abbott, Celgene, Eli Lilly, Janssen, LEO, Novartis, and Pfizer, Speakers bureau: Abbott, Celgene, Eli Lilly, Janssen, LEO, Novartis, and Pfizer