Real-world, single-centre experience of apremilast for the treatment of moderate to severe psoriasis

Wong, Terence H.; Sinclair, Susan; Smith, Barry L.; Fraser, Clare L.; Morton, C.A.

doi:10.1111/ced.13150

Cited by 21 publications

(33 citation statements)

References 3 publications

(3 reference statements)

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“…Our experience using apremilast in real‐world clinical practise shows its safety and efficacy for plaque psoriasis. The rate of patients with a PASI‐100 response in our experience (11.4%) was comparable with that in previous real‐world reports (8%, 15.3% and 18.5%, respectively). The adverse events were also similar to those of previous reports .…”

Section: Discussionsupporting

confidence: 89%

“…The adverse events were also similar to those of previous reports. [2][3][4][5][6][7][8][9] Like in other reports, the most frequent adverse event in our experience was diarrhea. The proportion of diarrhea in our patients was higher than those in clinical trials, probably because we tell each patient about the gastrointestinal side-effects in advance and then ask them about their experiences at each visit.…”

Section: Discussionsupporting

confidence: 84%

“…Apremilast has a relatively better safety profile than other systemic agents for psoriasis such as cyclosporin, methotrexate (MTX) and etretinate. Its safety and efficacy were shown in the ESTEEM 1 and 2 trials, and several experiences reported from overseas on real‐world patients treated with apremilast; however, to date, there have been no reports of real‐world use in Japan. Thus, here we report on 44 patients treated with apremilast in a real‐world setting.…”

Section: Introductionmentioning

confidence: 99%

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Real‐world use of apremilast for patients with psoriasis in Japan

Kishimoto

Komine

Hioki

et al. 2018

The Journal of Dermatology

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Apremilast is a novel oral phosphodiesterase 4 inhibitor effective for psoriasis. It regulates the production of pro-inflammatory mediators. Apremilast was approved in December 2016 in Japan; however, its efficacy and safety in a real-world setting among Japanese patients have not been reported. We report on 44 patients treated with apremilast between March and October 2017. The median treatment duration was 25 weeks (range, 2-33). Thirty-five patients (79.5%) continued the drug for at least 23 weeks, and five (11.4%) achieved a Psoriasis Area and Severity Index 100 response within 12 weeks. Nine patients discontinued the drug within 24 weeks mainly due to insufficient efficacy (n = 3) and adverse events (n = 4). Seven patients continued their previous systemic therapies such as cyclosporin (n = 1), methotrexate (n = 1), etretinate + methotrexate (n = 1) and biologics (n = 4) combined with apremilast. Of these patients, 55.9% had at least one adverse event although no severe adverse events. The most common adverse event was diarrhea (31.8%), followed by nausea (25.0%), headache (13.6%), abdominal discomfort (6.8%) and vomiting (6.8%). The proportion of diarrhea in our patients was higher than those of previous clinical trials. Among 10 patients with psoriatic arthritis, apremilast did not improve joint pain in nine (90%). To investigate the relationship between treatment efficacy and plaque size, we defined a small plaque as an individual rash diameter of 1 inch or less. The efficacy of apremilast was greater in patients with small plaques than in patients with large plaques.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 84%

Section: Introductionmentioning

confidence: 99%

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Real‐world use of apremilast for patients with psoriasis in Japan

Kishimoto

Komine

Hioki

et al. 2018

The Journal of Dermatology

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“…At apremilast initiation, the mean PASI of our patients (10.9) was very similar to that reported in three other real‐life works, 12,13,19 but lower than mean pre‐treatment PASI reported in real‐life paper (16.1) 18 and in ESTEEM 1/2 trials (18.7 and 18.9, respectively) 7,8 . Furthermore, we collected a mean baseline BSA higher than that found in the real‐life population by Mayba and Gooderham 19 (16.7% vs 9.6%) whereas other real‐life studies did not enquire this score.…”

Section: Discussionsupporting

confidence: 86%

“…Mean BMI was comparable to that of prior real‐life studies as well, but was slightly inferior to patients' BMI in RCTs 6‐8,11‐13 . Moreover, unlike other real‐life settings, our study population included all patients with both PsA and concomitant cutaneous PsO 11‐18 …”

Section: Discussionmentioning

confidence: 80%

Long‐term efficacy and safety of apremilast in psoriatic arthritis: Focus on skin manifestations and special populations

Balato

Campione

Cirillo

et al. 2020

Dermatologic Therapy

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Few real‐life studies evaluated long‐term apremilast therapy in the variable spectrum of clinical‐anamnestic features which can be found in psoriatic arthritis (PsA) patients. This real‐life retrospective observational study aimed to assess long‐term efficacy, safety, and tolerability of apremilast among patients with PsA and concomitant cutaneous psoriasis. A stratified analysis was performed on special populations, defined as (a) number (≤1 vs >2) of comorbidities, presence or absence of: (b) history of malignancy, and (c) previous exposure to biologics. Patients attending three Italian University and Hospital centers, who received at least one dose of apremilast and had at least one follow‐up visit were included. Ninety‐six patients with PsA were identified. Psoriasis Area and Severity Index (PASI), Body Surface Area, 28‐joint Disease Activity Score, and Dermatology Life Quality Index scores improved during treatment, already at week 4, relative to baseline. More than 2 comorbidities, history of malignancy and previous biologic treatment negatively influenced PASI responses. At least one adverse event was experienced by 56/96 patients, and 11/56 events required drug withdrawal. In conclusion, this study confirm efficacy and safety of apremilast on joints and skin involvement of PsA, highlighting which patients could have less favorable treatment response.

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Apremilast retention rate in clinical practice: observations from an Italian multi-center study

et al. 2022

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Objective There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence. Methods In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant. ResultsThe 356 enrolled patients (median age 60 [interquartile range IQR 52-67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7-34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96-0.99; p = 0.048 and 0.54 IQR 0.31-0.95; p = 0.03). Conclusion Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities. Key Points• Apremilast retention rates in this real-life cohort and trials are comparable.• The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years).• No different or more prevalent adverse events were observed.

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Real-world, single-centre experience of apremilast for the treatment of moderate to severe psoriasis

Cited by 21 publications

References 3 publications

Real‐world use of apremilast for patients with psoriasis in Japan

Real‐world use of apremilast for patients with psoriasis in Japan

Long‐term efficacy and safety of apremilast in psoriatic arthritis: Focus on skin manifestations and special populations

Apremilast retention rate in clinical practice: observations from an Italian multi-center study

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