Characterization and Outcomes in Patients Treated With Apremilast in Routine Clinical Practice in Spain: Results From the APPRECIATE Study

Herranz, Pedro; Trasobares, Lidia; Mateu, A.; Martínez, E.; Ruíz‐Villaverde, Ricardo; Baniandrés, Ofelia; Díaz, J. Mataix; Jiménez-Gómez, N.; Serra, M.Á.; Genao, D.P. Ruiz; Rivera, Noelia; Tercedor-Sánchez, J.; Garcia, C.; Cordey, Myriam; Herrera‐Acosta, Enrique

doi:10.1016/j.adengl.2021.07.015

Cited by 3 publications

(18 citation statements)

References 15 publications

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“…Patient demographic data (sex, age, and comorbidities) were similar to those described in other real‐life apremilast series 4–6 . They also found a high percentage of patients who had received prior systemic treatment.…”

Section: Discussionsupporting

confidence: 75%

“…F I G U R E 1 (A) Kaplan-Meier curve of apremilast survival in patients who received previous biological treatment (mean survival 9.9 months, SD 6.5) and those who did not (mean survival 9.4 months, SD 7.3), log-rank p = 0.92, hazard ratio (HR) 0.97 (IC 95% 0.5-1.9 Patient demographic data (sex, age, and comorbidities) were similar to those described in other real-life apremilast series. [4][5][6] They also found a high percentage of patients who had received prior systemic treatment. However, the proportion of patients who had received prior biological therapy was higher in our series (39%) than those reported in other apremilast real-life series (0%-19.4%), [4][5][6][7][8][9][10] probably due to the inclusion criteria of our study.…”

Section: T a B L E 1 Patient Baseline Demographics And Clinical Chara...mentioning

confidence: 97%

“…[4][5][6] They also found a high percentage of patients who had received prior systemic treatment. However, the proportion of patients who had received prior biological therapy was higher in our series (39%) than those reported in other apremilast real-life series (0%-19.4%), [4][5][6][7][8][9][10] probably due to the inclusion criteria of our study.…”

Section: T a B L E 1 Patient Baseline Demographics And Clinical Chara...mentioning

confidence: 97%

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Apremilast and biologics: Characteristics of patients treated with apremilast before, during, or after a biological treatment

Pinto-Pulido

Lario

González‐Cañete

et al. 2022

Dermatologic Therapy

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Apremilast is an oral small molecule approved for the treatment of psoriasis, psoriatic arthritis and oral ulcers associated with Behçet's disease. This research was conducted to describe the characteristics of patients who received treatment with apremilast for a skin disorder, either before, during, or after a biological treatment, with the aim of analyze the reasons that lead to start this drug in real clinical practice or suspend it for another. A total of 41 patients were enrolled: nine (22.0%) had received biological treatment prior to apremilast, seven (17.0%) both before and after apremilast and 25 (61.0%) after apremilast. One patient received concomitant treatment with adalimumab and apremilast. Most patients (85.4%) received apremilast as treatment for psoriasis. Reasons for starting apremilast were lack of efficacy with previous treatments (85.4%) and adverse effects or contraindication to previous treatments (14.6%), without statistically significant differences between patients who had received a previous biologic and those who had not. Drug survival was not influenced by previous biological treatment, but we found an increased risk of drug discontinuation in patients with chronic kidney disease (log-rank p = 0.028). The main reason of apremilast withdrawal was lack of adequate disease control (60.0%), most of whom required treatment with biologics. Therefore, despite the extensive development of new therapies for psoriasis and other dermatological conditions, apremilast is a widely used drug even in patients who are candidates for biologic treatment.Its initiation is more frequent due to poor disease control than because of other therapies contraindications.

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Section: Discussionsupporting

confidence: 75%

Section: T a B L E 1 Patient Baseline Demographics And Clinical Chara...mentioning

confidence: 97%

Section: T a B L E 1 Patient Baseline Demographics And Clinical Chara...mentioning

confidence: 97%

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Apremilast and biologics: Characteristics of patients treated with apremilast before, during, or after a biological treatment

Pinto-Pulido

Lario

González‐Cañete

et al. 2022

Dermatologic Therapy

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“…Although data from the APPRECIATE family of studies have been previously reported [ 23 , 25 , 29 ], it remains important to collect data from different European regions. In CEE, apremilast use is limited by country-specific reimbursement criteria, which are reflected in our cohort.…”

Section: Discussionmentioning

confidence: 99%

“…The multinational Apremilast Clinical Treatment Experience in Psoriasis (APPRECIATE) study was conducted to assess the effectiveness of apremilast in the real-world setting, and data from Northwestern Europe (Austria, Germany, Ireland, Sweden, Switzerland, and the UK) [ 23 , 24 ], Austria [ 29 ], and Spain [ 25 ] have been published. This is the first report on the real-world use of apremilast in the CEE region.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2023

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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. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02468-3.

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Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

Giofrè,

Fabbrocini,

Potenza

et al. 2023

Adv Ther

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Introduction While several European studies have reported real-world apremilast use, patient-perceived benefits, and treatment satisfaction, local reimbursement criteria for apremilast vary and data from Italy are limited. Methods The cross-sectional DARWIN study enrolled consecutive patients who had initiated apremilast for plaque psoriasis 6 (± 1) months prior to enrolment at a single visit across 24 Italian dermatological sites. Disease severity was assessed using body surface area (BSA) and Physician Global Assessment (PGA). Patient-reported outcomes assessed 6 (± 1) months after apremilast initiation were Dermatology Life Quality Index (DLQI), Patient Benefit Index (PBI), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Results Of 184 patients enrolled between July 2019 and January 2021, 180 were included in the analysis. At apremilast initiation, median (25th–75th percentile) time since psoriasis diagnosis was 8.6 (3.2–22.2) years; median BSA, 10.0% (5.0–16.0); mean (standard seviation, SD) DLQI total score, 13.5 (8.0). Over half (54.9%) of patients with available data reported psoriasis had a very or extremely large effect on their quality of life (QoL); half reported itching (50.6%) and/or special areas involvement (50.0%). Most (73.9%) had comorbidities and were biologic-naïve (81.5%). The most common reasons for initiating apremilast were lack of efficacy of previous treatment (56.7%) and contraindications to other treatments (44.4%). At 6 (± 1) months, most patients were continuing apremilast and/or reported a Global PBI score ≥ 1 (minimum clinical benefit) (86.1% and 90.0%, respectively); approximately half achieved BSA ≤ 3% and/or DLQI total score ≤ 5 (47.1% and 48.5%); 18.8% achieved PGA = 0; mean (SD) TSQM-9 global treatment satisfaction score was 59.0 (24.8). Apremilast was well tolerated; no new safety signals were identified. Conclusions Patients treated with apremilast for 6 months in Italian clinical practice reported improved QoL, clinically relevant improvements in symptoms, high treatment satisfaction, and high treatment persistence. Our data indicate apremilast is a valuable treatment option for moderate plaque psoriasis. Study Registration ClinicalTrials.gov identifier, NCT04031027. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02516-y.

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Characterization and Outcomes in Patients Treated With Apremilast in Routine Clinical Practice in Spain: Results From the APPRECIATE Study

Cited by 3 publications

References 15 publications

Apremilast and biologics: Characteristics of patients treated with apremilast before, during, or after a biological treatment

Apremilast and biologics: Characteristics of patients treated with apremilast before, during, or after a biological treatment

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

Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

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