Users of biologics in clinical practice : would they be eligible for phase III clinical studies? Cohort Study in the French Psoriasis Registry PSOBIOTEQ
© 2019 European Academy of Dermatology and Venereology..
BACKGROUND: Numerous inclusion and exclusion criteria are involved in phase III moderate to severe psoriasis trials investigating the safety and efficacy of biologics. This questions the generalization of results.
METHODS: In this cohort study, we applied inclusion/exclusion criteria for phase III trials from original protocols (adalimumab - REVEAL, ustekinumab - PHOENIX, brodalumab - AMAGINE, secukinumab FIXTURE) to all patients enrolled in the PsoBioTeq prospective registry who received a biological agent for the first time between July 2012 and November 2017. We then compared the efficacy, drug survival and occurrence of adverse events between patients who satisfied/did not satisfy the eligibility criteria for these phase III trials.
RESULTS: A total of 1267 patients were enrolled, of whom 993 (78.4%) were not eligible for at least one RCT (randomized controlled trial) and 251 (19.1%) did not meet the PASI/PGA severity requirements. Apart from disease severity, the most frequent criteria resulting in exclusion were as follows: non-plaque psoriasis (12.6%), significant cardiac disease (8.4%), significant liver disease (7.3%), elevated liver enzymes (4.9-9.6%) and personal history of diabetes (9.2%). There was no difference in drug survival between the two groups. The incidence ratio of adverse events was significantly lower in eligible versus non-eligible patients [0.78 (95% CI 0.62-0.97) (P = 0.03)].
CONCLUSION: The majority of patients treated with biologics in the PsoBioTeq real-life registry would not have been eligible for phase III moderate to severe psoriasis trials. Patients not eligible for psoriasis phase III clinical trials have a higher incidence of adverse events.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:34 |
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| Enthalten in: |
Journal of the European Academy of Dermatology and Venereology : JEADV - 34(2020), 2 vom: 01. Feb., Seite 293-300 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Masson Regnault, M [VerfasserIn] |
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| Links: |
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| Themen: |
Biological Products |
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| Anmerkungen: |
Date Completed 23.11.2020 Date Revised 23.11.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/jdv.15878 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM300296053 |
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| 100 | 1 | |a Masson Regnault, M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Users of biologics in clinical practice |b would they be eligible for phase III clinical studies? Cohort Study in the French Psoriasis Registry PSOBIOTEQ |
| 264 | 1 | |c 2020 | |
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| 500 | |a Date Completed 23.11.2020 | ||
| 500 | |a Date Revised 23.11.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2019 European Academy of Dermatology and Venereology. | ||
| 520 | |a BACKGROUND: Numerous inclusion and exclusion criteria are involved in phase III moderate to severe psoriasis trials investigating the safety and efficacy of biologics. This questions the generalization of results | ||
| 520 | |a METHODS: In this cohort study, we applied inclusion/exclusion criteria for phase III trials from original protocols (adalimumab - REVEAL, ustekinumab - PHOENIX, brodalumab - AMAGINE, secukinumab FIXTURE) to all patients enrolled in the PsoBioTeq prospective registry who received a biological agent for the first time between July 2012 and November 2017. We then compared the efficacy, drug survival and occurrence of adverse events between patients who satisfied/did not satisfy the eligibility criteria for these phase III trials | ||
| 520 | |a RESULTS: A total of 1267 patients were enrolled, of whom 993 (78.4%) were not eligible for at least one RCT (randomized controlled trial) and 251 (19.1%) did not meet the PASI/PGA severity requirements. Apart from disease severity, the most frequent criteria resulting in exclusion were as follows: non-plaque psoriasis (12.6%), significant cardiac disease (8.4%), significant liver disease (7.3%), elevated liver enzymes (4.9-9.6%) and personal history of diabetes (9.2%). There was no difference in drug survival between the two groups. The incidence ratio of adverse events was significantly lower in eligible versus non-eligible patients [0.78 (95% CI 0.62-0.97) (P = 0.03)] | ||
| 520 | |a CONCLUSION: The majority of patients treated with biologics in the PsoBioTeq real-life registry would not have been eligible for phase III moderate to severe psoriasis trials. Patients not eligible for psoriasis phase III clinical trials have a higher incidence of adverse events | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
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| 650 | 7 | |a Dermatologic Agents |2 NLM | |
| 700 | 1 | |a Castañeda-Sanabria, J |e verfasserin |4 aut | |
| 700 | 1 | |a Diep Tran, M H T |e verfasserin |4 aut | |
| 700 | 1 | |a Beylot-Barry, M |e verfasserin |4 aut | |
| 700 | 1 | |a Bachelez, H |e verfasserin |4 aut | |
| 700 | 1 | |a Beneton, N |e verfasserin |4 aut | |
| 700 | 1 | |a Chosidow, O |e verfasserin |4 aut | |
| 700 | 1 | |a Dupuy, A |e verfasserin |4 aut | |
| 700 | 1 | |a Joly, P |e verfasserin |4 aut | |
| 700 | 1 | |a Jullien, D |e verfasserin |4 aut | |
| 700 | 1 | |a Mahé, E |e verfasserin |4 aut | |
| 700 | 1 | |a Richard, M-A |e verfasserin |4 aut | |
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| 700 | 1 | |a Sbidian, E |e verfasserin |4 aut | |
| 700 | 1 | |a Paul, C |e verfasserin |4 aut | |
| 700 | 0 | |a PsoBioTeq Study Group |e verfasserin |4 aut | |
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