Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial

Gold, Linda Stein; Papp, Kim; Pariser, David M.; Green, Lawrence; Bhatia, Neal; Sofen, Howard; Albrecht, Lorne; Gooderham, Melinda; Chen, Mindy; Paris, Maria; Wang, Yao; Duffin, Kristina Callis

doi:10.1016/j.jaad.2021.07.040

Cited by 30 publications

(17 citation statements)

References 18 publications

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“…Although difficult to formally assess, there was a reduction of approximately 30% in the amount of topical treatments dispensed to patients, and a 20% decrease in change in tube weight in the second study phase (a raw proxy measure of overall topical use). The AE profile of apremilast was consistent with prior clinical trials in mild-to-moderate psoriasis and moderate-to-severe psoriasis, including a trial in Japanese patients [ 8 , 10 – 12 , 18 , 19 ].…”

Section: Discussionsupporting

confidence: 81%

“…This is notable, as sPGA score of 0 or 1 is a clinically meaningful benefit for patients with sPGA of 2 or 3 at baseline with limited treatment options. Although direct comparisons with other studies are not feasible owing to differences in study designs, populations, statistical power, and endpoints, rates of achieving sPGA response in PROMINENT were higher than rates observed at week 16 in placebo-controlled studies of apremilast in patients with mild-to-moderate psoriasis [ 12 , 19 ]. Efficacy and Safety in Patients With Moderate Plaque Psoriasis (UNVEIL) was a phase 4, placebo-controlled study of patients with moderate psoriasis who were naive to conventional systemic and biologic therapies.…”

Section: Discussionmentioning

confidence: 99%

“…Patients with mild-to-moderate psoriasis in Japan have limited systemic treatment options, as systemic biologic therapies are reserved for patients with more severe psoriasis [≥ 10% body surface area (BSA) involvement], and inadequate response to conventional therapies, including phototherapy [ 7 ]. Apremilast is a phosphodiesterase 4 inhibitor that was effective in treating moderate-to-severe psoriasis [ 8 – 11 ] and mild-to-moderate psoriasis in phase 3 clinical trials [ 12 ]. A pharmacokinetic modeling and exposure–response analysis study in patients with moderate-to-severe psoriasis treated with apremilast demonstrated similar maximal effects and response rates in a Japanese population versus a predominantly Caucasian population [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study

Okubo

Takahashi

Hino

et al. 2022

Dermatol Ther (Heidelb)

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Introduction Patients with mild-to-moderate plaque psoriasis often experience reduced quality of life and increased disease burden due to itch or involvement of psoriasis in special areas such as the scalp and nails. Systemic therapy may be used concurrently with topical therapy in patients with active disease not controlled by topical therapy alone. The objective of PROMINENT was to evaluate the efficacy and safety of apremilast in combination with topical therapy in patients with mild-to-moderate psoriasis in Japan. Methods PROMINENT, a phase 3b, open-label, single-arm study in Japan, enrolled adults ≥ 20 years of age with plaque psoriasis [static Physician Global Assessment (sPGA) 2 (mild) or 3 (moderate)] not adequately controlled by topical therapy. Patients received apremilast 30 mg twice daily for 16 weeks in addition to their existing topical therapy, with the option of topical therapy reduction at the discretion of their physician while continuing apremilast treatment from weeks 16 to 32. Results Of the 152 patients enrolled in the study, 136 completed week 32. The primary endpoint of sPGA response [score 0 (clear) or 1 (almost clear)] was achieved by 43.7% of patients at week 16, and 40.8% maintained response at week 32. Clinically meaningful improvements in skin, scalp, and nails were observed in > 40% of patients at weeks 16 and 32. Similarly, improvements in pruritus, quality of life, and treatment satisfaction were observed at week 16 and maintained at week 32. Common treatment-emergent adverse events through week 32 included gastrointestinal events, nasopharyngitis, and headache. Conclusions Apremilast in combination with topical therapy resulted in clinically meaningful and sustained efficacy in physician- and patient-reported outcomes at weeks 16 and 32 in Japanese patients with mild-to-moderate psoriasis. Tolerability was consistent with available prior safety data for apremilast. Trial Registration ClinicalTrials.gov identifier, NCT03930186.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study

Okubo

Takahashi

Hino

et al. 2022

Dermatol Ther (Heidelb)

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“…For example, patients with baseline Investigator's Global Assessment (IGA) score ≥2 were included in a real‐world registry evaluation the effectiveness of guselkumab 30 . One oral target agent, apremilast, has successfully expanded its indication into psoriasis patients with all degrees of severity 31,32 . Nonetheless, studies specifically targeting patients with mild‐to‐moderate diseases activity remained limited except for psoriasis localized on specific areas such as scalp, 33 palmoplantar areas 34 and genitalia 35 .…”

Section: Discussionmentioning

confidence: 99%

“…30 One oral target agent, apremilast, has successfully expanded its indication into psoriasis patients with all degrees of severity. 31,32 Nonetheless, studies specifically targeting patients with mild-to-moderate diseases activity remained limited except for psoriasis localized on specific areas such as scalp, 33 palmoplantar areas 34 and genitalia. 35 Recent articles also emphasized the importance of individualized treatment for psoriasis.…”

Section: Ta B L Ementioning

confidence: 99%

Predictors for the effectiveness of 75 mg risankizumab in treating psoriasis—A real‐word evidence from a 52‐week retrospective study

Hsieh,

Tseng,

Tsai

2023

Experimental Dermatology

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In the registration trial of risankizumab for patients with moderate‐to‐severe psoriasis in Japan, similar Psoriasis Area Severity Index (PASI) responses were observed for 75 mg or 150 mg risankizumab at most time points up to 52 weeks, except for PASI 100 at week 16. The use of 75 mg risankizumab offers an attractive option considering the high cost of risankizumab. However, it is unknown whether patients with mild‐to‐moderate psoriasis respond similarly, and the efficacy data of non‐Japanese patients is also lacking. We retrospectively included 30 consecutive Chinese patients receiving half‐dose (75 mg) risankizumab as scheduled up to 52 weeks. Compared with biologic‐experienced group, biologic‐naive group had a significantly higher PASI 50/75/90/100 achievement (p = 0.0098/0.0039/0.0016/0.0054) at week 52. PASI 50/75/90/100 curves in biologic‐naive group (p = 0.0117/0.0239/0.0143/0.0269) were also significantly higher when analysed generalized estimating equations (GEE) model. Though there was no statistically significant difference in terms of PASI 50/75/90/100 responses at any time points between those with body weight ≦ 65 kg and those >65 kg, a tendency of secondary failure was noted in those >65 kg from week 40 onwards. Patients who were both biologic‐naive and weighed ≦ 65 kg achieved sustained PASI 50/75/90 responses from week 16/28/40 onwards, respectively, indicating that they could be considered as potential candidates for 75 mg risankizumab. Though PASI 75 curve in patients without diabetes mellitus (DM) surpassed that in patient without DM, curves of other parameters did not reach significance when analysed by GEE model. There was no HBV, HCV or TB reactivation, nor other new safety signals during the 52‐week observational period. Providing risankizumab with flexible dosing options is beneficial in clinical practice considering the high cost of this medication.

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Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis

Sbidian

Chaimani

García‐Doval

et al. 2022

Cochrane Database of Systematic Reviews

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Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial

Cited by 30 publications

References 18 publications

Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study

Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study

Predictors for the effectiveness of 75 mg risankizumab in treating psoriasis—A real‐word evidence from a 52‐week retrospective study

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis

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