A real‐world, non‐interventional, prospective study of the effectiveness and safety of apremilast in bio‐naïve adults with moderate plaque psoriasis treated in the routine care in Greece – the ‘<scp>APRAISAL</scp>’ study

Ioannidis, Dimitrios; Antonakopoulos, Nikolaos; Chasapi, Vasiliki; Oikonomou, Chrysa; Tampouratzi, Eleftheria; Lazaridou, Elizabeth; Rigopoulos, Dimitrios; Neofotistou, O; Drosos, Alexandros A.; Anastasiadis, Georgios; Rovithi, Evangelia; Kalinou, Christina; Papadavid, Evangelia; Aronis, P; Papageorgiou, Marina; Protopapa, A; Bassukas, Ioannis D.; Lefaki, I; Zafiriou, Efterpi; Krasagakis, Konstantinos; Pokas, E; Anagnostopoulos, Z; Kekki, A; Papakonstantis, Markos

doi:10.1111/jdv.18166

Cited by 8 publications

(10 citation statements)

References 41 publications

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“…A total of 12 publications investigated patients with PP treated with apremilast (APR) including four placebo (PBO)-controlled RCTs [ 11 , 12 , 14 – 16 ], two randomized methotrexate (MTX) comparative trials [ 19 , 20 ], four prospective/retrospective cohort studies [ 22 – 24 , 26 ], and two case series [ 27 , 29 ] (Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

“…2022 [ 20 ] MTX comparative trial Apremilast methotrexate combination vs. methotrexate 60 (baseline PPPGA ≥ 3) 80.0 vs. 60.0 (APR + MTX vs. MTX) (week 16) [ P = < 0.05] Mean PPPASI improvement (%): 81.5 vs. 71.7 (APR + MTX vs. MTX) (week 16) [ P = 0.002] PPPASI 75 (%): 43.3 vs. 30.0 (APR + MTX vs. MTX) (week 16) [ P = 0.001] Mean DLQI improvement (%): 66.9 vs. 58.9 (APR + MTX vs. MTX) (week 16) [ P = 0.001] Ioannides et al . 2021 [ 22 ] APRAISAL Prospective Cohort None 111 (44 with baseline PPPGA ≥ 3) 72.7 (week 52) [95% CI = 59.6–85.9] Median DLQI score improvement (%): 75.0 (week 24) (includes non-palmoplantar psoriasis) Del Alcázar et al . 2020 [ 23 ] Retrospective cohort None 85 (mean baseline PPPGA 4.2) 36.1 and 83.3 (weeks 12 and 52) (as observed) Drug survival after 1 year of treatment (%): 54.9 (includes non-palmoplantar psoriasis) Reich et al .…”

Section: Resultsmentioning

confidence: 99%

“…Four prospective/retrospective cohort studies evaluating apremilast in PP suggest that apremilast may be able to produce clearance over an extended period. APRAISAL, a 52-week prospective cohort study in Greece [ 22 ], demonstrated long– term clearance (PPPGA 0 or 1 at week 52) in 72.7% [95% CI = 59.6–85.9] of patients with moderate to severe PP treated with apremilast ( n = 44). In a 52-week retrospective cohort study by the Spanish Psoriasis Group [ 23 ], the rates of patients treated with apremilast ( n = 85, mean baseline PPPGA 4.2) achieving PPPGA 0 or 1 was 36.1 and 83.3% (as observed) at weeks 12 and 52, respectively.…”

Section: Resultsmentioning

confidence: 99%

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Apremilast in Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Meta-analysis

Spencer

Elhage

Jin

et al. 2023

Dermatol Ther (Heidelb)

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Background This review’s goals were to investigate apremilast’s efficacy versus placebo in palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP), and apremilast’s efficacy versus methotrexate in PP. Methods A literature search was conducted in PubMed, clinicaltrials.gov, and Embase in July 2022. Publications investigating subjects with PP or PPP, treated with apremilast, which reported palmoplantar-specific outcomes were used. Exclusion criteria included cases of drug-induced PP/PPP, case studies, non-English texts, omission of palmoplantar-specific outcomes, and incomplete publications. Studies were assessed for risk of bias using Cochrane Review Manager application and CASP checklist. Primary endpoints were a 50% improvement of the Palmoplantar Psoriasis/Pustulosis Area and Severity Index (PPPASI 50) and improvement of the Palmoplantar Physician Global Assessment (PPPGA) to 0 or 1 in patients with baseline PPPGA ≥ 3. Results Seventeen original studies including five placebo-controlled randomized clinical trials (RCTs), one phase II clinical trial, two randomized methotrexate comparative trials, six cohort studies, and three case series were analyzed, totaling 1117 participants. Meta-analysis of four placebo-controlled RCTs investigating PP found apremilast treatment to be superior to placebo in achieving a PPPGA of 0/1 (baseline PPPGA of ≥ 3) after 16 weeks of treatment ( n = 244; OR = 2.69 [1.39–5.22]). Apremilast was superior to placebo in achieving PPPASI 50 at week 16 in the only placebo-controlled RCT of PPP (78.3 vs. 40.9%) [ P = 0.0003]. Apremilast was comparable to methotrexate in achieving PPPASI 50 at week 16 in PP (59.5 vs. 64.3%; n = 84; [ P = 0.65]). Non-randomized studies generally showed marked improvement in PPPASI, PPPGA, and DLQI scores following apremilast treatment. Discussion Apremilast treatment in PP and PPP resulted in significant improvement in objective, palmoplantar-specific clinical parameters versus placebo, and comparable efficacy with methotrexate in PP. Limitations in interpreting these results include variations in palmoplantar-specific metrics used and risk of bias of included studies. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-022-00877-w.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Apremilast in Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Meta-analysis

Spencer

Elhage

Jin

et al. 2023

Dermatol Ther (Heidelb)

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“…In addition, a strong correlation was observed between the global PBI score and the TSQM-9 global and subscale scores. More recently, the APRAISAL study evaluated real-world apremilast use in a cohort of 287 biologic-naïve patients with moderate psoriasis in Greece; 68% of patients achieved a 75% reduction in their PASI score (PASI 75) and clinically relevant improvements in the severity of itching and scalp and palmoplantar involvement were observed [ 22 ]. The OTELO study assessed the real-world use and effectiveness of apremilast in patients with moderate-to-severe plaque psoriasis from the patient and physician perspectives, reporting that apremilast improved PROs, including QoL and psoriasis severity, and fulfilled patients’ expectations [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

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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“…The study of Ioannides et al 6 . is an example to how design a study to provide real‐world evidence on the effectiveness on QoL – measured using the Dermatology Life Quality Index (DLQI), disease severity – assessed by the Psoriasis Area Severity Index (PASI), pruritus and presence of psoriasis in specific psoriasis manifestations and safety of apremilast in bio‐naïve adult patients with moderate plaque psoriasis.…”

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confidence: 99%

Real‐world experience on the efficacy and safety of apremilast in bio‐naïve patients with moderate plaque psoriasis

Conti

Tiberio

2022

Acad Dermatol Venereol

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Plaque psoriasis is a skin disorder associated with systemic inflammation, various comorbidities and clinical manifestations that have a significant impact on the patients' emotional well-being and overall quality of life (QoL). In addition to emotional distress, patients report an impact of the disease on their work productivity, daily activities and sleep quality. [1][2][3] The choice of treatment for the management of psoriasis depends on disease activity, patients' needs and the presence of comorbid conditions for which certain treatment options are contraindicated. 3 Real-world studies are necessary to complement the evidence of randomized controlled trials and more accurately depict patient profiles better suited for treatment with apremilast. Nonetheless, real-world studies conducted thus far, mainly report on findings in patients with moderate-to-severe psoriasis, previously treated with conventional and/or biological therapies, while patients with moderate disease and na€ ıve to biologics are underrepresented. 4,5 The study of Ioannides et al. 6 is an example to how design a study to provide real-world evidence on the effectiveness on QoLmeasured using the Dermatology Life Quality Index (DLQI), disease severityassessed by the Psoriasis Area Severity Index (PASI), pruritus and presence of psoriasis in specific psoriasis manifestations and safety of apremilast in bio-na€ ıve adult patients with moderate plaque psoriasis.The 52-week APRAISAL study demonstrated that bio-na€ ıve patients with moderate plaque psoriasis, and a median 10-year disease duration, treated with apremilast, experience an improvement in QoL and pruritus severity, as well as reduced skin, nail, scalp and palmoplantar involvement.These results highlight the importance of assessing various measures of disease burden in clinical practice, rather than focusing only on PASI score, as the latter does not fully capture all troublesome symptoms of the disease from a patient's perspective.In fact, while various studies suggest a strong or at least moderate correlation between DLQI and PASI improvements, there is also evidence of discordance between physicians and patients on psoriasis treatment outcomes.

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A real‐world, non‐interventional, prospective study of the effectiveness and safety of apremilast in bio‐naïve adults with moderate plaque psoriasis treated in the routine care in Greece – the ‘APRAISAL’ study

Cited by 8 publications

References 41 publications

Apremilast in Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Meta-analysis

Apremilast in Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Meta-analysis

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

Real‐world experience on the efficacy and safety of apremilast in bio‐naïve patients with moderate plaque psoriasis

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