Real-World Experience of Patient-Relevant Benefits and Treatment Satisfaction with Apremilast in Patients with Psoriasis: An Analysis of the APPRECIATE Study

Klein, Toni Maria; Blome, Christine; Kleyn, C. Elise; Conrad, Curdin; Sator, Paul; Ståhle, Mona; Eyerich, Kilian; Radtke, Marc Alexander; Bundy, Christine; Cordey, Myriam; Griffiths, Christopher E.M.; Augustin, Matthias

doi:10.1007/s13555-021-00628-3

Cited by 9 publications

(14 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We report data from patients treated at 13 sites across Austria, and their physicians. The methods of this multinational, observational, retrospective, cross-sectional study have been described by Augustin et al 20 and Klein et al 21 and are summarized in brief below.…”

Section: Methodsmentioning

confidence: 99%

“…The study included patients ⩾18 years with physician-diagnosed chronic plaque psoriasis treated with apremilast according to routine clinical practice, who could be contacted 6 (±1) months after apremilast initiation. 20 , 21 All consecutive patients at each site were considered to minimize bias in patient selection. Patients who provided written informed consent were enrolled regardless of whether they were continuing apremilast treatment.…”

Section: Methodsmentioning

confidence: 99%

“…Overall results from a European cohort of six countries (Austria, Ireland, Germany, Sweden, Switzerland, and the United Kingdom) have been reported previously. 20 , 21 We report data from the Austrian cohort.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Characteristics and outcomes of patients with psoriasis treated with apremilast in the real-world in Austria – results the APPRECIATE study

Jonak

Göttfried²,

Perl-Convalexius³

et al. 2023

Therapeutic Advances in Chronic Disease

Self Cite

View full text Add to dashboard Cite

Background: Apremilast, an oral phosphodiesterase 4 inhibitor, is approved in the European Union for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients refractory or contraindicated to or intolerant of other systemic therapies. Objectives: The APPRECIATE study assessed apremilast use in real-world practice and its clinical value to physicians and patients. APPRECIATE was a multinational, observational, retrospective, cross-sectional study. Methods: Apremilast effectiveness at 6 (±1) months was assessed on the basis of psoriasis severity and health-related quality-of-life scores and treatment satisfaction using physician/patient-reported outcomes, respectively. We report the Austrian cohort of 72 patients. Results: At 6 (±1) months, three-quarters of patients remained on apremilast, while physicians and patients reported treatment benefits across all psoriasis symptoms and manifestations. Of patients, the majority were satisfied with their treatment and achieved treatment goals considered most relevant. Patients’ and physicians’ perceptions of treatment effectiveness were aligned, and health-related quality-of-life scores indicated an improvement in the majority of patients. Apremilast tolerability was consistent with the known safety profile. Conclusions: Among psoriasis patients receiving apremilast in Austria, improvement in clinical outcomes were observed and satisfaction with apremilast treatment among patients and physicians was high. Registration: ClinicalTrials.gov NCT02740218

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Characteristics and outcomes of patients with psoriasis treated with apremilast in the real-world in Austria – results the APPRECIATE study

Jonak

Göttfried²,

Perl-Convalexius³

et al. 2023

Therapeutic Advances in Chronic Disease

Self Cite

View full text Add to dashboard Cite

show abstract

“…The detailed methods of the APPRECIATE study have been described by Augustin et al [ 23 ] and Klein et al [ 24 ] and are briefly summarized below. Supplemental Figure S1 provides an overview of the study design and outcome measures.…”

Section: Methodsmentioning

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

View full text Add to dashboard Cite

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.

show abstract

Long‐Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials

Mease

Gladman

Gómez-Reino

et al. 2020

ACR Open Rheumatology

View full text Add to dashboard Cite

Objective Psoriatic arthritis (PsA) requires long‐term treatment, yet safety concerns and monitoring requirements make maintenance a challenge. This analysis of pooled Psoriatic Arthritis Long‐term Assessment of Clinical Efficacy (PALACE) 1, 2, and 3 data describes 3‐year apremilast safety and tolerability in PsA. Methods Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily. Placebo patients were re‐randomized to apremilast 30 mg twice daily or 20 mg twice daily at week 16 (early escape) or 24. Double‐blind treatment continued to week 52; patients could continue apremilast during an open‐label, long‐term treatment phase. Results In total, 1493 patients received at least one dose of study medication and were included in the safety population (placebo: n = 495; apremilast 30 mg: n = 497; apremilast 20 mg: n = 501). Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment. Greater rates of adverse events (AEs) were reported with apremilast (61.1%; exposure‐adjusted incidence rate [EAIR]/100 patient‐years, 265.1) versus placebo (47.5%; EAIR/100 patient‐years, 200.7) in the placebo‐controlled period. During weeks 0 to ≤52, the most common AEs occurring in apremilast‐exposed patients were diarrhea (13.9%; EAIR/100 patient‐years, 18.6), nausea (12.3%; EAIR/100 patient‐years, 16.0), headache (9.4%; EAIR/100 patient‐years, 12.1), upper respiratory tract infection (9.1%; EAIR/100 patient‐years, 11.5), and nasopharyngitis (6.2%; EAIR/100 patient‐years, 7.7). Most AEs were mild/moderate with apremilast exposure ≤156 weeks. Rates of depression remained low (EAIR/100 patient‐years, 1.8). Major adverse cardiac events (EAIR/100 patient‐years, 0.5), malignancies (EAIR/100 patient‐years, 0.9), and serious opportunistic infections (EAIR/100 patient‐years, 0.0) were infrequent over the 3‐year exposure period. Discontinuation rates due to AEs were low (<7.5%) across all apremilast‐exposure periods. Incidences of clinically meaningful abnormalities in postbaseline laboratory values was low; most values returned to baseline levels with continued treatment and without intervention. Conclusion Apremilast demonstrated a favorable safety profile and was well tolerated up to 156 weeks.

show abstract

Real-World Experience of Patient-Relevant Benefits and Treatment Satisfaction with Apremilast in Patients with Psoriasis: An Analysis of the APPRECIATE Study

Cited by 9 publications

References 28 publications

Characteristics and outcomes of patients with psoriasis treated with apremilast in the real-world in Austria – results the APPRECIATE study

Characteristics and outcomes of patients with psoriasis treated with apremilast in the real-world in Austria – results the APPRECIATE study

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

Long‐Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials

Contact Info

Product

Resources

About