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Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis

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Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. / Gordon, K B; Lebwohl, M; Papp, K A; Bachelez, H; Wu, J J; Langley, R G; Blauvelt, A; Kaplan, B; Shah, M; Zhao, Y; Sinvhal, R; Reich, K.

in: BRIT J DERMATOL, Jahrgang 186, Nr. 3, 03.2022, S. 466-475.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Gordon, KB, Lebwohl, M, Papp, KA, Bachelez, H, Wu, JJ, Langley, RG, Blauvelt, A, Kaplan, B, Shah, M, Zhao, Y, Sinvhal, R & Reich, K 2022, 'Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis', BRIT J DERMATOL, Jg. 186, Nr. 3, S. 466-475. https://doi.org/10.1111/bjd.20818

APA

Gordon, K. B., Lebwohl, M., Papp, K. A., Bachelez, H., Wu, J. J., Langley, R. G., Blauvelt, A., Kaplan, B., Shah, M., Zhao, Y., Sinvhal, R., & Reich, K. (2022). Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. BRIT J DERMATOL, 186(3), 466-475. https://doi.org/10.1111/bjd.20818

Vancouver

Gordon KB, Lebwohl M, Papp KA, Bachelez H, Wu JJ, Langley RG et al. Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. BRIT J DERMATOL. 2022 Mär;186(3):466-475. https://doi.org/10.1111/bjd.20818

Bibtex

@article{ee4256d9aa84460984a39c09fd1b6071,
title = "Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis",
abstract = "BACKGROUND: Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.OBJECTIVES: To evaluate safety data from risankizumab psoriasis phase I-III clinical trials.METHODS: Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I-III completed and ongoing trials.RESULTS: Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients.CONCLUSIONS: Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.",
keywords = "Antibodies, Monoclonal/adverse effects, Clinical Trials as Topic, Humans, Psoriasis/drug therapy, Severity of Illness Index, Treatment Outcome",
author = "Gordon, {K B} and M Lebwohl and Papp, {K A} and H Bachelez and Wu, {J J} and Langley, {R G} and A Blauvelt and B Kaplan and M Shah and Y Zhao and R Sinvhal and K Reich",
note = "{\textcopyright} 2021 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.",
year = "2022",
month = mar,
doi = "10.1111/bjd.20818",
language = "English",
volume = "186",
pages = "466--475",
journal = "BRIT J DERMATOL",
issn = "0007-0963",
publisher = "Wiley-Blackwell",
number = "3",

}

RIS

TY - JOUR

T1 - Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis

AU - Gordon, K B

AU - Lebwohl, M

AU - Papp, K A

AU - Bachelez, H

AU - Wu, J J

AU - Langley, R G

AU - Blauvelt, A

AU - Kaplan, B

AU - Shah, M

AU - Zhao, Y

AU - Sinvhal, R

AU - Reich, K

N1 - © 2021 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

PY - 2022/3

Y1 - 2022/3

N2 - BACKGROUND: Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.OBJECTIVES: To evaluate safety data from risankizumab psoriasis phase I-III clinical trials.METHODS: Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I-III completed and ongoing trials.RESULTS: Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients.CONCLUSIONS: Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.

AB - BACKGROUND: Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.OBJECTIVES: To evaluate safety data from risankizumab psoriasis phase I-III clinical trials.METHODS: Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I-III completed and ongoing trials.RESULTS: Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients.CONCLUSIONS: Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.

KW - Antibodies, Monoclonal/adverse effects

KW - Clinical Trials as Topic

KW - Humans

KW - Psoriasis/drug therapy

KW - Severity of Illness Index

KW - Treatment Outcome

U2 - 10.1111/bjd.20818

DO - 10.1111/bjd.20818

M3 - SCORING: Journal article

C2 - 34652810

VL - 186

SP - 466

EP - 475

JO - BRIT J DERMATOL

JF - BRIT J DERMATOL

SN - 0007-0963

IS - 3

ER -