Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL

February 2018 | Volume 17 | Issue 2 | Original Article | 221 | Copyright © February 2018


Linda Stein Gold MD,a Jerry Bagel MD,b Mark Lebwohl MD,c J. Mark Jackson MD,d Rongdean Chen PhD,e Joana Goncalves MD,e Eugenia Levi PharmD,e Kristina Callis Duffin MD MSf

aHenry Ford Health System, West Bloomfield, MI bPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ cIcahn School of Medicine at Mount Sinai, New York, NY dUniversity of Louisville, Forefront Dermatology, Louisville, KY eCelgene Corporation, Summit, NJ fUniversity of Utah, Salt Lake City, UT

treatment have not yet been described exclusively in patients with moderate disease. However, results from other longer-term studies in patients with moderate to severe psoriasis are consistent with findings from the current 52-week study.23,24

CONCLUSION

In UNVEIL, improvements in signs and symptoms of moderate plaque psoriasis (BSA 5% to 10%) achieved with 16 weeks of apremilast treatment10 were sustained or displayed continued improvement with treatment that extended up to 52 weeks in systemic- and biologic-naive patients. Apremilast had a significantly positive and sustained impact on QOL and treatment satisfaction, with few patients discontinuing longer-term treatment because of AEs. The open-label apremilast treatment phase further demonstrated that apremilast is a systemic treatment with a favorable risk-benefit profile that may be appropriate for patients with moderate plaque psoriasis.

DISCLOSURES

Linda Stein Gold: Celgene Corporation, LEO Pharma, Novartis, Pfizer, and Stiefel/GlaxoSmithKline–investigator and/or consultant.Jerry Bagel: AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, and Valeant–advisory board member, speaker, consultant, and/or research support; Sun Pharma–consultant.Mark Lebwohl: Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, MedImmune/AstraZeneca, Novartis, Pfizer, and ViDac–research support through Icahn School of Medicine at Mount Sinai.J. Mark Jackson: AbbVie, Amgen, Celgene Corporation, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, Promius, and TopMD–research, honoraria, consulting, and/or other support.Rongdean Chen: Celgene Corporation–employment at the time of study conduct.Joana Goncalves: Celgene Corporation–employment.Eugenia Levi: Celgene Corporation–employment.Kristina Callis Duffin: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Centocor/Janssen, Eli Lilly, Novartis, Pfizer, Regeneron, Stiefel, and XenoPort–consultant, steering committee member, advisory board member, has received grants, and/or has received honoraria.

ACKNOWLEDGMENTS

The authors acknowledge financial support for this study from Celgene Corporation. The authors received editorial support in the preparation of this manuscript from Karen Dougherty, PhD, and Amy Shaberman, PhD, of Peloton Advantage, LLC, Parsippany, NJ, USA, funded by Celgene Corporation, Summit, NJ, USA. The authors, however, directed and are fully responsible for all content and editorial decisions for this manuscript. All authors had full access to all of the data, and data are available upon request.

REFERENCES

  1. Siliq [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America; 2017.
  2. Enstilar [package insert]. Madison, NJ: LEO Pharma Inc; 2016.
  3. Otezla [package insert]. Summit, NJ: Celgene Corporation; June 2017.
  4. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
  5. Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013;149(10):1180-1185.
  6. Lebwohl MG, Bachelez H, Barker J, et al. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol. 2014;70(5):871-881.
  7. Nast A, Mrowietz U, Kragballe K, et al. Barriers to the prescription of systemic therapies for moderate-to-severe psoriasis--a multinational cross-sectional study. Arch Dermatol Res. 2013;305(10):899-907.
  8. Papp K, Reich K, Leonardi CL, et al. 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]). J Am Acad Dermatol. 2015;73(1):37-49.
  9. Paul C, Cather J, Gooderham M, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis over 52 weeks: a phase III, randomized, controlled trial (ESTEEM 2). Br J Dermatol. 2015;173(6):1387-1399.
  10. Strober B, Bagel J, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate plaque psoriasis with lower BSA: week 16 results from the UNVEIL study. J Drugs Dermatol. 2017;16(8):801-808.
  11. Callis Duffin K, Papp KA, Bagel J, Levi E, Chen R, Gottlieb AB. Evaluation of the physician global assessment and body surface area composite tool for assessing psoriasis response to apremilast therapy: results from ESTEEM 1 and ESTEEM 2. J Drugs Dermatol. 2017;16(2):147-153.
  12. Walsh JA, McFadden M, Woodcock J, et al. Product of the Physician Global Assessment and body surface area: a simple static measure of psoriasis severity in a longitudinal cohort. J Am Acad Dermatol. 2013;69(6):931-937.
  13. Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004;2:12.
  14. Ortonne J, Chimenti S, Luger T, Puig L, Reid F, Trueb RM. Scalp psoriasis: European consensus on grading and treatment algorithm. J Eur Acad Dermatol Venereol. 2009;23(12):1435-1444.
  15. Kragballe K. Management of difficult to treat locations of psoriasis. Scalp, face, flexures, palm/soles and nails. Curr Probl Dermatol. 2009;38:160-171.
  16. Crowley J, Gooderham M, Wasel N, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with nail, scalp, and palmoplantar psoriasis: 52-week results from the ESTEEM 2 trial [poster 894]. Presented at: the 73rd Annual Meeting of the American Academy of Dermatology; March 20-24, 2015; San Francisco, CA.
  17. Mrowietz U, Chouela EN, Mallbris L, et al. Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study. J Eur Acad Dermatol Venereol. 2015;29(6):1114-1120.
  18. Zachariae R, Zachariae CO, Lei U, Pedersen AF. Affective and sensory dimensions of pruritus severity: associations with psychological symptoms and quality of life in psoriasis patients. Acta Derm Venereol. 2008;88(2):121-127.
  19. Globe D, Bayliss MS, Harrison DJ. The impact of itch symptoms in psoriasis: results from physician interviews and patient focus groups. Health Qual Life Outcomes. 2009;7:62.
  20. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Longterm (52-week) results of a phase III randomized, controlled trial of apremilast in patients with psoriatic arthritis. J Rheumatol. 2015;42(3):479-488.
  21. Edwards CJ, Blanco FJ, Crowley J, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis. 2016;75(6):1065-1073.
  22. Reich K, Gooderham M, Green L, et al. The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
  23. Papp KA, Reich K, Sobell JM, et al. Two-year safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: results from a phase 3, randomized, controlled trial (ESTEEM 1) [abstract 1055]. J Am Acad Dermatol. 2015;72(5 Suppl 1):AB256.
  24. Reich K, Goodfield M, Green L, et al. Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment in the LIBERATE study [abstract]. Presented at: Annual Meeting of the American Academy of Dermatology; March 3-7, 2017; Orlando, FL.

AUTHOR CORRESPONDENCE

Linda Stein Gold MD LSTEIN1@hfhs.org