Short-term reasons for withdrawal and adverse events associated with apremilast therapy for psoriasis in real-world practice compared with in clinical trials: A multicenter retrospective study

Ighani, Arvin; Georgakopoulos, Jorge R.; Shear, Neil H.; Walsh, Scott; Yeung, Jensen

doi:10.1016/j.jaad.2017.09.067

Cited by 28 publications

(30 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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 . Like in other reports, the most frequent adverse event in our experience was diarrhea.…”

Section: Discussionsupporting

confidence: 92%

“…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%

See 2 more Smart Citations

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

Kishimoto

Komine

Hioki

et al. 2018

The Journal of Dermatology

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 84%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Kishimoto

Komine

Hioki

et al. 2018

The Journal of Dermatology

View full text Add to dashboard Cite

show abstract

“…, 58.7% by Ighani et al. ) . The most common event was loose stools or diarrhea; its rate was 37%, was similar to previous studies (31.8% by Kishimoto et al.…”

Section: Discussionsupporting

confidence: 86%

Real‐world experiences of apremilast in clinics for Japanese patients with psoriasis

Saruwatari¹

2019

The Journal of Dermatology

View full text Add to dashboard Cite

Psoriasis, though not an immediately life‐threatening disorder, still lowers quality of life and disrupts daily functions. While many treatments for psoriasis exist, few are convenient and safe long term; even if sufficiently effective, treatments themselves often decrease quality of life and make long‐term treatment adherence difficult. Approved in Japan in December 2016, apremilast was expected to function as a simple, long‐term, systemic therapeutic agent for psoriasis. We report on the clinical outcomes of administrating apremilast for 2 years as observed in 46 psoriatic patients at the Saruwatari Dermatology Clinic between March 2017 and February 2019. We believe the ease of clinic consultation (as compared with large general hospital consultation) draws patients who are busy or have mild symptoms, and consequently poor adherence to regular visits and treatment, reflecting realistic conditions. Major adverse events with apremilast treatment were diarrhea (37.0%) and nausea (15.3%), with most cases of diarrhea being mild. Drug survival analysis by the Kaplan–Meier method revealed a 1‐year continuation rate of 46.8% and a 2‐year continuation rate of 37.4%. Dermatology Life Quality Index (DLQI) scores during the observation period declined from 9.3 to 2.8 (P < 0.0001) on average, with the DLQI‐0/1 achievement rate being 28.6%. Based on our findings, we conclude that apremilast is suitable as a long‐lasting basic treatment that is easy to prescribe in small clinics and easy to use in everyday life.

show abstract

“…Furthermore, approximately half of the reported nausea and diarrhoea AEs resolved within 1 month of treatment in the RCTs . Our coauthors previously reported the real‐world 16‐week safety outcomes of apremilast in patients with psoriasis . However, there are scant data evaluating safety trends in real‐world practice beyond 16 weeks.…”

Section: Characteristics Of the Study Cohort And Safety Outcomes Of Pmentioning

confidence: 99%

Long‐term 52‐week trends in apremilast safety outcomes for treatment of psoriasis in clinical practice: a multicentre, retrospective case series

et al. 2018

View full text Add to dashboard Cite

Short-term reasons for withdrawal and adverse events associated with apremilast therapy for psoriasis in real-world practice compared with in clinical trials: A multicenter retrospective study

Cited by 28 publications

References 4 publications

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

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

Real‐world experiences of apremilast in clinics for Japanese patients with psoriasis

Long‐term 52‐week trends in apremilast safety outcomes for treatment of psoriasis in clinical practice: a multicentre, retrospective case series

Contact Info

Product

Resources

About