Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe

Petra Cetkovská, Iva Dediol, Marija Šola, Martina Kojanová, Katarina Trčko, Antoanela Čarija, Romana Čeović, Daniela Ledić-Drvar, Marija Kaštelan, Andina Hrabar, Myriam Cordey Missoup, Khalid Mamun, Petra Cetkovská, Iva Dediol, Marija Šola, Martina Kojanová, Katarina Trčko, Antoanela Čarija, Romana Čeović, Daniela Ledić-Drvar, Marija Kaštelan, Andina Hrabar, Myriam Cordey Missoup, Khalid Mamun

Abstract

Introduction: The broad and sustained efficacy of apremilast for psoriasis has been demonstrated in randomized and real-world observational studies. Data from Central and Eastern Europe (CEE) are lacking. Moreover, apremilast use in this region is limited by country-specific reimbursement criteria. This is the first study to report data on the real-world use of apremilast in the region.

Methods: APPRECIATE (NCT02740218) was an observational, retrospective, cross-sectional study assessing psoriasis patients 6 (± 1) months after apremilast treatment initiation. The study aimed to describe the characteristics of patients with psoriasis receiving apremilast, estimate treatment outcomes, including Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI), and assess dermatologists' and patients' perspectives on treatment using questionnaires including the Patient Benefit Index (PBI). Adverse event reports were taken from the medical records.

Results: Fifty patients (Croatia: 25; Czech Republic: 20; Slovenia: 5) were enrolled. In patients continuing apremilast at 6 (± 1) months, mean (± SD) PASI score was reduced from 16.2 ± 8.7 points at treatment initiation to 3.1 ± 5.2 at 6 (± 1) months; BSA from 11.9% ± 10.3% to 0.8% ± 0.9%; DLQI from 13.7 ± 7.4 points to 1.6 ± 3.2. PASI 75 was reached by 81% of patients. Physicians reported that the overall treatment success fulfilled their expectations in more than two thirds of patients (68%). At least three-quarters of patients reported apremilast had a quite or very high benefit on the needs they identified as being most important. Apremilast was well tolerated; no serious or fatal adverse events were identified.

Conclusion: Apremilast was effective in reducing skin involvement and improving quality of life in CEE patients having severe disease. Treatment satisfaction among physicians and patients was very high. These data add to the growing body of evidence showing consistent effectiveness of apremilast across the continuum of psoriasis disease severity and manifestations.

Trial registration: ClinicalTrials.gov identifier, NCT02740218.

Keywords: Apremilast; Health-related quality of life; Psoriasis drug therapy; Psoriasis severity scores; Real-world data.

© 2023. The Author(s).

Figures

Fig. 1
Fig. 1
Psoriasis disease severity and HRQoL scores at treatment initiation and at month 6 (± 1) and absolute change in patients with ongoing apremilast therapy. HRQoL health-related quality of life, SD standard deviation. Mean (SD) values are calculated based on the number of patients with assessments at baseline and month 6 (± 1) visit (n). The instruments used were Psoriasis Area and Severity Index (PASI) [30], Dermatology Life Quality Index (DLQI) [31], Physician Global Assessment (PGA) [30], and body surface area (BSA) [30]
Fig. 2
Fig. 2
Partial achievement of, achievement of, or exceeding physicians’ expectations. Percentages show the proportions of patients partially achieving, achieving, or exceeding dermatologists’ expectations in any of the indicated areas. Physicians’ expectations were assessed using a study-specific questionnaire
Fig. 3
Fig. 3
Treatment effect of apremilast on symptoms assessed by patients and physicians. Percentages represent individuals responding “agree” or “strongly agree” and are based on non-missing responses (n). Specific areas of psoriasis were the scalp, hands, soles of feet, nails, or genitals. Physicians’ and patients’ estimates of apremilast treatment effect were assessed using a study-specific questionnaire

References

    1. Boehncke WH, Schön MP. Psoriasis. Lancet. 2015;386(9997):983–994. doi: 10.1016/s0140-6736(14)61909-7.
    1. International Federation of Psoriasis Associations (IFPA), International League of Dermatological Societies (ILDS), International Psoriasis Council (IPC). Global Psoriasis Atlas. 2021. .
    1. Balp MM, Khalil S, Tian H, Gabriel S, Vietri J, Zuberbier T. Burden of chronic urticaria relative to psoriasis in five European countries. J Eur Acad Dermatol Venereol. 2018;32(2):282–290. doi: 10.1111/jdv.14584.
    1. Amatya B, Wennersten G, Nordlind K. Patients' perspective of pruritus in chronic plaque psoriasis: a questionnaire-based study. J Eur Acad Dermatol Venereol. 2008;22(7):822–826. doi: 10.1111/j.1468-3083.2008.02591.x.
    1. 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. doi: 10.1186/1477-7525-7-62.
    1. Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr, Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3 Pt 1):401–407. doi: 10.1016/s0190-9622(99)70112-x.
    1. Lebwohl MG, Bachelez H, Barker J, Girolomoni G, Kavanaugh A, Langley RG, 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):871–81.e1-30. doi: 10.1016/j.jaad.2013.12.018.
    1. Feldman SR, Goffe B, Rice G, Mitchell M, Kaur M, Robertson D, et al. The challenge of managing psoriasis: unmet medical needs and stakeholder perspectives. Am Health Drug Benefits. 2016;9(9):504–513.
    1. Langley RG, Krueger GG, Griffiths CE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(Suppl 2):ii18–23. doi: 10.1136/ard.2004.033217.
    1. Armstrong A, Jarvis S, Boehncke WH, Rajagopalan M, Fernandez-Penas P, Romiti R, et al. Patient perceptions of clear/almost clear skin in moderate-to-severe plaque psoriasis: results of the Clear About Psoriasis worldwide survey. J Eur Acad Dermatol Venereol. 2018;32(12):2200–2207. doi: 10.1111/jdv.15065.
    1. Reich K, Gisondi P, Stein Gold L, van de Kerkhof P, Langley RGP, Carle, Puig L, et al., editors. Differences in patient and dermatologist perspectives on psoriasis treatment: results from the UPLIFT survey. In: 30th European Academy of Dermatology and Venereology (EADV) congress; 2021 (virtual).
    1. Kavanaugh A, Helliwell P, Ritchlin CT. Psoriatic arthritis and burden of disease: patient perspectives from the population-based multinational assessment of psoriasis and psoriatic arthritis (MAPP) survey. Rheumatol Ther. 2016;3(1):91–102. doi: 10.1007/s40744-016-0029-z.
    1. Zozaya N, Villoro R, Abdalla F, Alfonso Zamora S, BaleaFilgueiras J, Carrascosa Carrillo JM, et al. Unmet needs in the management of moderate-to-severe psoriasis in Spain: a multidimensional evaluation. Acta Dermato-Venereol. 2022;102:adv00678. doi: 10.2340/actadv.v102.583.
    1. Nast A, Smith C, Spuls PI, Avila Valle G, Bata-Csorgo Z, Boonen H, et al. EuroGuiDerm guideline on the systemic treatment of psoriasis vulgaris—Part 2: specific clinical and comorbid situations. J Eur Acad Dermatol Venereol. 2021;35(2):281–317. doi: 10.1111/jdv.16926.
    1. Nast A, Smith C, Spuls PI, Avila Valle G, Bata-Csörgö Z, Boonen H, et al. EuroGuiDerm guideline on the systemic treatment of psoriasis vulgaris—Part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venereol. 2020;34(11):2461–2498. doi: 10.1111/jdv.16915.
    1. Mrowietz U, Augustin M. Using the upgrade criteria of the European Psoriasis Consensus is best practice care according to the people-centred healthcare concept of the World Health Organization. Br J Dermatol. 2022;187:1007–8. 10.1111/bjd.21827.
    1. Strober B, Ryan C, van de Kerkhof P, van der Walt J, Kimball AB, Barker J, et al. Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council. J Am Acad Dermatol. 2020;82(1):117–122. doi: 10.1016/j.jaad.2019.08.026.
    1. European Medicines Agency. Otezla summary of medicinal product characteristics London: European Medicines Agency; 2021. . Accessed 04 Oct 2021.
    1. Papp K, Reich K, Leonardi CL, Kircik L, Chimenti S, Langley RG, 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. doi: 10.1016/j.jaad.2015.03.049.
    1. Paul C, Cather J, Gooderham M, Poulin Y, Mrowietz U, Ferrandiz C, 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. doi: 10.1111/bjd.14164.
    1. Reich K, Gooderham M, Green L, Bewley A, Zhang Z, Khanskaya I, 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. doi: 10.1111/jdv.14015.
    1. Stein Gold L, Bagel J, Lebwohl M, Jackson JM, Chen R, Goncalves J, et al. Efficacy and safety of apremilast in systemic- and biologic-naive patients with moderate plaque psoriasis: 52-week results of UNVEIL. J Drugs Dermatol. 2018;17(2):221–228.
    1. Augustin M, Kleyn CE, Conrad C, Sator PG, Stahle M, Eyerich K, et al. Characteristics and outcomes of patients treated with Apremilast in the real world: results from the APPRECIATE study. J Eur Acad Dermatol Venereol. 2021;35(1):123–134. doi: 10.1111/jdv.16431.
    1. Klein TM, Blome C, Kleyn CE, Conrad C, Sator PG, Stahle M, et al. Real-world experience of patient-relevant benefits and treatment satisfaction with Apremilast in patients with psoriasis: an analysis of the APPRECIATE study. Dermatol Ther (Heidelb) 2022;12(1):81–95. doi: 10.1007/s13555-021-00628-3.
    1. Herranz P, Trasobares L, Mateu A, Martínez E, Ruiz-Villaverde R, Baniandrés O, et al. Characterization and outcomes in patients treated with Apremilast in routine clinical practice in Spain: results from the APPRECIATE study. Actas Dermo-Sifiliografic. 2021 doi: 10.1016/j.ad.2021.05.010.
    1. Ghislain PD, Lambert J, Hoai XL, Hillary T, Roquet-Gravy PP, de la Brassinne M, et al. Real-life effectiveness of Apremilast for the treatment of psoriasis in Belgium: results from the observational OTELO study. Adv Ther. 2022;39(2):1068–1080. doi: 10.1007/s12325-021-01981-7.
    1. de Vlam K, Toukap AN, Kaiser MJ, Vanhoof J, Remans P, Van den Berghe M, et al. Real-world efficacy and safety of Apremilast in Belgian patients with psoriatic arthritis: results from the prospective observational APOLO study. Adv Ther. 2022;39(2):1055–1067. doi: 10.1007/s12325-021-02016-x.
    1. Ioannides D, Antonakopoulos N, Georgiou S, Chasapi V, Katsantonis I, Drosos A, et al. Effectiveness and safety of apremilast in biologic-naïve patients with moderate psoriasis treated in routine clinical practice in Greece: the APRAISAL study. J Eur Acad Dermatol Venereol. 2021;35(9):1838–1848. doi: 10.1111/jdv.17392.
    1. Jonak C, Göttfried I, Perl-Convalexius S, Gruber B, Schütz-Bergmayr M, Vujic I, et al. Characteristics and outcomes of patients with psoriasis treated with apremilast in the real-world in Austria—results the APPRECIATE study. Ther Adv Chronic Dis. 2023;14:20406223231152785. doi: 10.1177/20406223231152785.
    1. Chalmers RJ. Assessing psoriasis severity and outcomes for clinical trials and routine clinical practice. Dermatol Clin. 2015;33(1):57–71. doi: 10.1016/j.det.2014.09.005.
    1. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210–216. doi: 10.1111/j.1365-2230.1994.tb01167.x.
    1. Feuerhahn J, Blome C, Radtke M, Augustin M. Validation of the patient benefit index for the assessment of patient-relevant benefit in the treatment of psoriasis. Arch Dermatol Res. 2012;304(6):433–441. doi: 10.1007/s00403-012-1256-y.
    1. Atkinson MJ, Kumar R, Cappelleri JC, Hass SL. Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Health. 2005;8(Suppl 1):S9–S24. doi: 10.1111/j.1524-4733.2005.00066.x.
    1. Amin M, Lee EB, Bhutani T, Wu JJ. Review of European registries for psoriasis. J Dermatol Treat. 2019;30(3):227–236. doi: 10.1080/09546634.2018.1506084.
    1. Merola JF, Qureshi A, Husni ME. Underdiagnosed and undertreated psoriasis: nuances of treating psoriasis affecting the scalp, face, intertriginous areas, genitals, hands, feet, and nails. Dermatol Ther. 2018;31(3):e12589. doi: 10.1111/dth.12589.
    1. Aldredge LM, Higham RC. Manifestations and management of difficult-to-treat psoriasis. J Dermatol Nurses' Assoc. 2018;10(4):189. doi: 10.1097/JDN.0000000000000418.
    1. Merola JF, Li T, Li WQ, Cho E, Qureshi AA. Prevalence of psoriasis phenotypes among men and women in the USA. Clin Exp Dermatol. 2016;41(5):486–489. doi: 10.1111/ced.12805.
    1. Reich K, Korge B, Magnolo N, Manasterski M, Schwichtenberg U, Staubach-Renz P, et al. Quality-of-life outcomes, effectiveness and tolerability of apremilast in patients with plaque psoriasis and routine German dermatology care: results from LAPIS-PSO. Dermatol Ther (Heidelb) 2022;12(1):203–221. doi: 10.1007/s13555-021-00658-x.
    1. Koskivirta I, Ruotsalainen J, Kurki S, Lakkakorpi P, Salminen-Mankonen H, Pirilä L, et al. Real-world registry-based study on apremilast use in psoriasis and psoriatic arthritis in Finland. Scand J Rheumatol. 2023 doi: 10.1080/03009742.2022.2151109.
    1. Verbenko DA, Karamova AE, Artamonova OG, Deryabin DG, Rakitko A, Chernitsov A, et al. Apremilast pharmacogenomics in Russian patients with moderate-to-severe and severe psoriasis. J Pers Med. 2021;11(1):20. doi: 10.3390/jpm11010020.
    1. Kubanov AA, Artamonova OG, Karamova AE, Vasileva EL, Deryabin DG. Cytokine levels of skin lesions in moderate and severe psoriasis as predictors for the type 4 fosphodiesterase inhibitor (apremilast) therapy effectivness. Ann RAMS. 2020;75(5):500–507. doi: 10.15690/vramn1361.

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