On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approach
If an authorized drug is prescribed for a use that is not described in the Summary of Product Characteristics, this is defined as ‘off-label use.’ Methotrexate is often used off-label for dermatological indications. Off-label use is permitted if physicians can justify the treatment based on scientif...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-05-01
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| Series: | Journal of Dermatological Treatment |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/09546634.2021.1961999 |
| _version_ | 1797683470709817344 |
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| author | Astrid M. van Huizen Francisca M. Vermeulen Cathelijne M. J. M. Bik Rinke Borgonjen Saskia A. T. Karsch Rosanna A. Kuin Louise A. A. Gerbens Phyllis I. Spuls |
| author_facet | Astrid M. van Huizen Francisca M. Vermeulen Cathelijne M. J. M. Bik Rinke Borgonjen Saskia A. T. Karsch Rosanna A. Kuin Louise A. A. Gerbens Phyllis I. Spuls |
| author_sort | Astrid M. van Huizen |
| collection | DOAJ |
| description | If an authorized drug is prescribed for a use that is not described in the Summary of Product Characteristics, this is defined as ‘off-label use.’ Methotrexate is often used off-label for dermatological indications. Off-label use is permitted if physicians can justify the treatment based on scientific evidence available to them. Our objective here was therefore to summarize the evidence for the effectiveness, efficacy, and safety of the dermatological off-label use of methotrexate in a systematic review. We searched MEDLINE, EMBASE, and CENTRAL for studies for evidence on the effectiveness, efficacy, and safety of the off-label use of methotrexate in dermatological indications up to November 2019. We used the GRADE system to rate the quality of the evidence. The search retrieved 34,583 hits of which 3566 were selected after the title and abstract screening. After the full-text screening, 143 studies were included, which involved 3688 patients in total. We found low-quality evidence for the effectiveness, efficacy, and safety of the off-label use of methotrexate in 31 dermatological diseases. To optimize the quality of evidence to support off-label use, we need high-quality studies in which well-characterized patients are treated with standardized treatments regimens using well-validated outcomes relevant to patients and physicians. |
| first_indexed | 2024-03-12T00:15:59Z |
| format | Article |
| id | doaj.art-64065a9522b14f56846fe2002aef59cb |
| institution | Directory Open Access Journal |
| issn | 0954-6634 1471-1753 |
| language | English |
| last_indexed | 2024-03-12T00:15:59Z |
| publishDate | 2022-05-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj.art-64065a9522b14f56846fe2002aef59cb2023-09-15T14:28:51ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532022-05-013341947196610.1080/09546634.2021.19619991961999On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approachAstrid M. van Huizen0Francisca M. Vermeulen1Cathelijne M. J. M. Bik2Rinke Borgonjen3Saskia A. T. Karsch4Rosanna A. Kuin5Louise A. A. Gerbens6Phyllis I. Spuls7Department of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of AmsterdamDepartment of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of AmsterdamGeneral Practitioner (Self-employed)Department of Dermatology, Gelderland Valley HospitalDepartment of Family Medicine, UMC UtrechtDepartment of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of AmsterdamDepartment of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of AmsterdamDepartment of Dermatology, Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of AmsterdamIf an authorized drug is prescribed for a use that is not described in the Summary of Product Characteristics, this is defined as ‘off-label use.’ Methotrexate is often used off-label for dermatological indications. Off-label use is permitted if physicians can justify the treatment based on scientific evidence available to them. Our objective here was therefore to summarize the evidence for the effectiveness, efficacy, and safety of the dermatological off-label use of methotrexate in a systematic review. We searched MEDLINE, EMBASE, and CENTRAL for studies for evidence on the effectiveness, efficacy, and safety of the off-label use of methotrexate in dermatological indications up to November 2019. We used the GRADE system to rate the quality of the evidence. The search retrieved 34,583 hits of which 3566 were selected after the title and abstract screening. After the full-text screening, 143 studies were included, which involved 3688 patients in total. We found low-quality evidence for the effectiveness, efficacy, and safety of the off-label use of methotrexate in 31 dermatological diseases. To optimize the quality of evidence to support off-label use, we need high-quality studies in which well-characterized patients are treated with standardized treatments regimens using well-validated outcomes relevant to patients and physicians.http://dx.doi.org/10.1080/09546634.2021.1961999off-labelmtxdermatologygrade approach |
| spellingShingle | Astrid M. van Huizen Francisca M. Vermeulen Cathelijne M. J. M. Bik Rinke Borgonjen Saskia A. T. Karsch Rosanna A. Kuin Louise A. A. Gerbens Phyllis I. Spuls On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approach Journal of Dermatological Treatment off-label mtx dermatology grade approach |
| title | On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approach |
| title_full | On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approach |
| title_fullStr | On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approach |
| title_full_unstemmed | On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approach |
| title_short | On which evidence can we rely when prescribing off-label methotrexate in dermatological practice? – a systematic review with GRADE approach |
| title_sort | on which evidence can we rely when prescribing off label methotrexate in dermatological practice a systematic review with grade approach |
| topic | off-label mtx dermatology grade approach |
| url | http://dx.doi.org/10.1080/09546634.2021.1961999 |
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