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Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies
BACKGROUND: Certolizumab pegol (CZP) is an Fc‐free, PEGylated anti‐tumour necrosis factor biologic. OBJECTIVES: To report 3‐year safety data from three phase III trials of CZP in adults with plaque psoriasis. METHODS: Data were pooled from CIMPASI‐1 (NCT02326298), CIMPASI‐2 (NCT02326272) and CIMPACT...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246928/ https://www.ncbi.nlm.nih.gov/pubmed/32531798 http://dx.doi.org/10.1111/bjd.19314 |
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author | Blauvelt, A. Paul, C. van de Kerkhof, P. Warren, R.B. Gottlieb, A.B. Langley, R.G. Brock, F. Arendt, C. Boehnlein, M. Lebwohl, M. Reich, K. |
author_facet | Blauvelt, A. Paul, C. van de Kerkhof, P. Warren, R.B. Gottlieb, A.B. Langley, R.G. Brock, F. Arendt, C. Boehnlein, M. Lebwohl, M. Reich, K. |
author_sort | Blauvelt, A. |
collection | PubMed |
description | BACKGROUND: Certolizumab pegol (CZP) is an Fc‐free, PEGylated anti‐tumour necrosis factor biologic. OBJECTIVES: To report 3‐year safety data from three phase III trials of CZP in adults with plaque psoriasis. METHODS: Data were pooled from CIMPASI‐1 (NCT02326298), CIMPASI‐2 (NCT02326272) and CIMPACT (NCT02346240). Included patients had moderate‐to‐severe plaque psoriasis of ≥ 6 months’ duration; had been randomized to CZP 200 mg every 2 weeks (Q2W) (400 mg at weeks 0, 2 and 4) or CZP 400 mg Q2W; and had received at least one dose of CZP with up to 144 weeks of exposure. Treatment‐emergent adverse events (TEAEs) were classified using MedDRA v18·1. Reported incidence rates (IRs) are incidence of new cases per 100 patient‐years (PY). RESULTS: Over 144 weeks, 995 patients received at least one dose of CZP (exposure: 2231·3 PY); 731 and 728 received at least one dose of CZP 200 mg Q2W (1211·4 PY) and/or 400 mg Q2W (1019·9 PY), respectively. The IR [95% confidence interval (CI)] of TEAEs was 144·9 (135·3–155·0) for all patients, 134·1 (123·2–145·7) for CZP 200 mg Q2W and 158·3 (145·5–171·9) for CZP 400 mg Q2W. The IR (95% CI) of serious TEAEs for all patients was 7·5 (6·4–8·8); the IRs were 6·7 (5·2–8·3) and 8·7 (6·9–10·8) for CZP 200 mg and 400 mg Q2W, respectively. Overall, 3·2% of patients reported serious infections (2·2% within each of the CZP 200 and 400 mg Q2W groups). Overall, there was one case of active tuberculosis, 16 malignancies in 14 patients and seven deaths (two considered treatment‐related). The cumulative IR of TEAEs did not increase over time. CONCLUSIONS: No new safety signals were identified compared with previously reported data. Risk did not increase with longer or higher CZP exposure. |
format | Online Article Text |
id | pubmed-8246928 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-82469282021-07-02 Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies Blauvelt, A. Paul, C. van de Kerkhof, P. Warren, R.B. Gottlieb, A.B. Langley, R.G. Brock, F. Arendt, C. Boehnlein, M. Lebwohl, M. Reich, K. Br J Dermatol Original Articles BACKGROUND: Certolizumab pegol (CZP) is an Fc‐free, PEGylated anti‐tumour necrosis factor biologic. OBJECTIVES: To report 3‐year safety data from three phase III trials of CZP in adults with plaque psoriasis. METHODS: Data were pooled from CIMPASI‐1 (NCT02326298), CIMPASI‐2 (NCT02326272) and CIMPACT (NCT02346240). Included patients had moderate‐to‐severe plaque psoriasis of ≥ 6 months’ duration; had been randomized to CZP 200 mg every 2 weeks (Q2W) (400 mg at weeks 0, 2 and 4) or CZP 400 mg Q2W; and had received at least one dose of CZP with up to 144 weeks of exposure. Treatment‐emergent adverse events (TEAEs) were classified using MedDRA v18·1. Reported incidence rates (IRs) are incidence of new cases per 100 patient‐years (PY). RESULTS: Over 144 weeks, 995 patients received at least one dose of CZP (exposure: 2231·3 PY); 731 and 728 received at least one dose of CZP 200 mg Q2W (1211·4 PY) and/or 400 mg Q2W (1019·9 PY), respectively. The IR [95% confidence interval (CI)] of TEAEs was 144·9 (135·3–155·0) for all patients, 134·1 (123·2–145·7) for CZP 200 mg Q2W and 158·3 (145·5–171·9) for CZP 400 mg Q2W. The IR (95% CI) of serious TEAEs for all patients was 7·5 (6·4–8·8); the IRs were 6·7 (5·2–8·3) and 8·7 (6·9–10·8) for CZP 200 mg and 400 mg Q2W, respectively. Overall, 3·2% of patients reported serious infections (2·2% within each of the CZP 200 and 400 mg Q2W groups). Overall, there was one case of active tuberculosis, 16 malignancies in 14 patients and seven deaths (two considered treatment‐related). The cumulative IR of TEAEs did not increase over time. CONCLUSIONS: No new safety signals were identified compared with previously reported data. Risk did not increase with longer or higher CZP exposure. John Wiley and Sons Inc. 2020-09-06 2021-04 /pmc/articles/PMC8246928/ /pubmed/32531798 http://dx.doi.org/10.1111/bjd.19314 Text en © 2020 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Blauvelt, A. Paul, C. van de Kerkhof, P. Warren, R.B. Gottlieb, A.B. Langley, R.G. Brock, F. Arendt, C. Boehnlein, M. Lebwohl, M. Reich, K. Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies |
title | Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies |
title_full | Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies |
title_fullStr | Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies |
title_full_unstemmed | Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies |
title_short | Long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo‐controlled studies |
title_sort | long‐term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase iii, randomized, placebo‐controlled studies |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246928/ https://www.ncbi.nlm.nih.gov/pubmed/32531798 http://dx.doi.org/10.1111/bjd.19314 |
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