The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index.
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)
Open accessAbstract
BACKGROUND: Apremilast, an oral phosphodiesterase 4 inhibitor, regulates immune responses associated with psoriasis. OBJECTIVES: ESTEEM 2 evaluated the efficacy and safety of apremilast 30 mg twice daily for moderate-to-severe plaque psoriasis. METHODS: This phase III, double-blind, placebo-controlled trial randomized adults to apremilast or placebo (2 : 1). At week 16, placebo patients switched to apremilast. At week 32, apremilast patients achieving ≥ 50% reduction in Psoriasis Area and Severity Index (PASI 50) were rerandomized (1 : 1) to continue apremilast or receive placebo. Upon loss of 50% of PASI improvement obtained at week 32, patients rerandomized to placebo resumed apremilast. RESULTS: The modified intention-to-treat population (full analysis set) included 137 placebo and 274 apremilast patients. At week 16, significantly more apremilast patients achieved PASI 75 (28·8%), PASI 50 (55·5%) and static Physician's Global Assessment score of 0 or 1 (20·4%) vs. placebo (5·8%, 19·7%, 4·4%, respectively; P < 0·001). Most patients rerandomized to apremilast at week 32 had a PASI 50 response at week 52 (80%). Patients treated with apremilast showed significant improvements in quality of life (as assessed by the Dermatology Life Quality Index) and pruritus at week 16 compared with placebo (P < 0·001). The exposure-adjusted incidence of adverse events did not increase with continued apremilast treatment for up to 52 weeks. The most common adverse events were nausea, diarrhoea, nasopharyngitis and upper respiratory tract infection. CONCLUSIONS: Apremilast was effective in the treatment of moderate-to-severe plaque psoriasis over 52 weeks.
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Cites
Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence
Parisi, R., Symmons, D. P. M., Griffiths, C. E. M., & Ashcroft, D. M. (2013) · Journal of Investigative Dermatology · doi:10.1038/jid.2012.339 · Cited by 2,592
Definition of treatment goals for moderate to severe psoriasis: a European consensus
Mrowietz, U., Kragballe, K., Reich, K., Spuls, P., Griffiths, C. E. M., Nast, A., Franke, J., Antoniou, C., Arenberger, P., Balieva, F., et al. (2011) · Archives of Dermatological Research · doi:10.1007/s00403-010-1080-1 · Cited by 898
Self-citationArican, O., Aral, M., Sasmaz, S., & Ciragil, P. (2005) · Mediators of Inflammation · doi:10.1155/mi.2005.273 · Cited by 805
Pathirana, D., Ormerod, A., Saiag, P., Smith, C., Spuls, P., Nast, A., Barker, J., Bos, J., Burmester, G., Chimenti, S., et al. (2009) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/j.1468-3083.2009.03389.x · Cited by 703
Self-citationPapp, K., Reich, K., Leonardi, C. L., Kircik, L., Chimenti, S., Langley, R. G. B., Hu, C., Stevens, R. M., Day, R. M., Gordon, K. B., et al. (2015) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2015.03.049 · Cited by 678
Self-citationLebwohl, M. G., Bachelez, H., Barker, J., Girolomoni, G., Kavanaugh, A., Langley, R. G., Paul, C. F., Puig, L., Reich, K., & van de Kerkhof, P. C. M. (2014) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2013.12.018 · Cited by 515
Self-citationApremilast mechanism of action and application to psoriasis and psoriatic arthritis
Schafer, P. (2012) · Biochemical Pharmacology · doi:10.1016/j.bcp.2012.01.001 · Cited by 439
Schafer, P., Parton, A., Gandhi, A., Capone, L., Adams, M., Wu, L., Bartlett, J., Loveland, M., Gilhar, A., Cheung, Y., et al. (2010) · British Journal of Pharmacology · doi:10.1111/j.1476-5381.2009.00559.x · Cited by 406
Armstrong, A. W., Robertson, A. D., Wu, J., Schupp, C., & Lebwohl, M. G. (2013) · JAMA Dermatology · doi:10.1001/jamadermatol.2013.5264 · Cited by 386
The concept of psoriasis as a systemic inflammation: implications for disease management
Reich, K. (2012) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/j.1468-3083.2011.04410.x · Cited by 360
Cited by
Nast, A., Smith, C., Spuls, P. I., Avila Valle, G., Bata‐Csörgö, Z., Boonen, H., De Jong, E., Garcia‐Doval, I., Gisondi, P., Kaur‐Knudsen, D., et al. (2020) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.16915 · Cited by 420
Self-citationComparison of Biologics and Oral Treatments for Plaque Psoriasis: A Meta-analysis
Armstrong, A. W., Puig, L., Joshi, A., Skup, M., Williams, D., Li, J., Betts, K. A., & Augustin, M. (2020) · JAMA Dermatology · doi:10.1001/jamadermatol.2019.4029 · Cited by 294
Edwards, C. J., Blanco, F. J., Crowley, J., Birbara, C. A., Jaworski, J., Aelion, J., Stevens, R. M., Vessey, A., Zhan, X., & Bird, P. (2016) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2015-207963 · Cited by 287
Self-citationA Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis
Simpson, E. L., Imafuku, S., Poulin, Y., Ungar, B., Zhou, L., Malik, K., Wen, H.-C., Xu, H., Estrada, Y. D., Peng, X., et al. (2019) · Journal of Investigative Dermatology · doi:10.1016/j.jid.2018.10.043 · Cited by 120
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Metadata
- Authors
- Paul, C., Cather, J., Gooderham, M., Poulin, Y., Mrowietz, U., Ferrandiz, C., Crowley, J., Hu, C., Stevens, R. M., Shah, K., Day, R. M., Girolomoni, G., & Gottlieb, A. B.
- Venue
- British Journal of Dermatology
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-11-07
- Volume
- 173
- Issue
- 6
- Pages
- 1387-1399
- ISSN
- 0007-0963 (ISSN-L)
- 1365-2133
- OpenAlex
- W2131727392
- Cited by
- 484
- References
- 18
- FWCI
- 20.34
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Paul, C., Cather, J., Gooderham, M., Poulin, Y., Mrowietz, U., Ferrandiz, C., Crowley, J., Hu, C., Stevens, R. M., Shah, K., Day, R. M., Girolomoni, G., & Gottlieb, A. B. (2015). 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). British Journal of Dermatology. https://doi.org/10.1111/bjd.14164
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