Publicação
Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis
| Resumo: | Objectives: To update the evidence for the efficacy and safety of (b)biological and (ts)targeted-synthetic disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League Against Rheumatism (ASAS/EULAR) recommendations for the management of axSpA. Methods: Systematic literature review (2009-2016) for randomised controlled trials (RCT), including longterm extensions, strategy trials and observational studies (the latter was only for safety assessment and a comparator was required). Interventions were any bDMARD or tsDMARD. All relevant efficacy and safety outcomes were included. Results: 76 papers and 24 abstracts fulfilled the inclusion criteria. Large treatment effects were found both in radiographic axSpA (r-axSpA) and nonradiographic axSpA (nr-axSpA) for all tumour necrosis factor inhibitors (TNFi) (NNT to achieve ASAS40 response ranged between 2.6-5.2 for r-axSpA and 2.3-5.4 for nr-axSpA). For nr-axSpA, efficacy was superior for those who had objective signs of inflammation ( positive C reactive protein or inflammation on MRI-SI). Secukinumab 150 mg has shown efficacy in two phase 3 RCTs (NNT to achieve ASAS40 response: 3.4 and 4.0). Ustekinumab and tofacitinib have shown positive results in phase 2/proof-of-concept trials; trials with apremilast, rituximab, interleukin (IL)-6 antagonists and abatacept have failed their primary end points. New (unknown) safety signals were not found in the trials but longterm observational safety data for TNFi are still scarce. Conclusions: New evidence supports the efficacy and safety of TNFi both in r-axSpA and nr-axSpA. Secukinumab is the first drug targeting the IL-17 pathway in r-axSpA that has shown efficacy. © Published by the BMJ Publishing Group Limited. |
|---|---|
| Autores principais: | Sepriano, A. |
| Outros Autores: | Sepriano, Alexandre; Regel, A.; Van Der Heijde, D.; Braun, J.; Baraliakos, X.; Landewé, R.; Van Den Bosch, F.; Falzon, L.; Ramiro, S.; Ramiro, Sofia |
| Assunto: | DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment |
| Ano: | 2017 |
| País: | Portugal |
| Tipo de documento: | recensão |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade Nova de Lisboa |
| Idioma: | inglês |
| Origem: | Repositório Institucional da UNL |
| _version_ | 1867100369681645568 |
|---|---|
| author | Sepriano, A. |
| author2 | Sepriano, Alexandre Regel, A. Van Der Heijde, D. Braun, J. Baraliakos, X. Landewé, R. Van Den Bosch, F. Falzon, L. Ramiro, S. Ramiro, Sofia |
| author2_role | author author author author author author author author author author |
| author_facet | Sepriano, A. Sepriano, Alexandre Regel, A. Van Der Heijde, D. Braun, J. Baraliakos, X. Landewé, R. Van Den Bosch, F. Falzon, L. Ramiro, S. Ramiro, Sofia |
| author_role | author |
| contributor_name_str_mv | NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) BMJ Publishing Group RUN |
| country_str | PT |
| creators_json_txt | [{\"Person.name\":\"Sepriano, A.\"},{\"Person.name\":\"Sepriano, Alexandre\",\"Person.identifier.orcid\":\"0000-0003-1954-0229\"},{\"Person.name\":\"Regel, A.\"},{\"Person.name\":\"Van Der Heijde, D.\"},{\"Person.name\":\"Braun, J.\"},{\"Person.name\":\"Baraliakos, X.\"},{\"Person.name\":\"Landewé, R.\"},{\"Person.name\":\"Van Den Bosch, F.\"},{\"Person.name\":\"Falzon, L.\"},{\"Person.name\":\"Ramiro, S.\"},{\"Person.name\":\"Ramiro, Sofia\",\"Person.identifier.orcid\":\"0000-0002-8899-9087\"}] |
| datacite.contributors.contributor.contributorName.fl_str_mv | NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) BMJ Publishing Group RUN |
| datacite.creators.creator.creatorName.fl_str_mv | Sepriano, A. Sepriano, Alexandre Regel, A. Van Der Heijde, D. Braun, J. Baraliakos, X. Landewé, R. Van Den Bosch, F. Falzon, L. Ramiro, S. Ramiro, Sofia |
| datacite.date.Accepted.fl_str_mv | 2017-01-27T00:00:00Z |
| datacite.date.available.fl_str_mv | 2017-10-12T22:02:20Z |
| datacite.date.embargoed.fl_str_mv | 2017-10-12T22:02:20Z |
| datacite.rights.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| datacite.subjects.subject.fl_str_mv | DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment |
| datacite.titles.title.fl_str_mv | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| dc.contributor.none.fl_str_mv | NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) BMJ Publishing Group RUN |
| dc.creator.none.fl_str_mv | Sepriano, A. Sepriano, Alexandre Regel, A. Van Der Heijde, D. Braun, J. Baraliakos, X. Landewé, R. Van Den Bosch, F. Falzon, L. Ramiro, S. Ramiro, Sofia |
| dc.date.Accepted.fl_str_mv | 2017-01-27T00:00:00Z |
| dc.date.available.fl_str_mv | 2017-10-12T22:02:20Z |
| dc.date.embargoed.fl_str_mv | 2017-10-12T22:02:20Z |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | http://hdl.handle.net/10362/24127 |
| dc.language.none.fl_str_mv | eng |
| dc.rights.none.fl_str_mv | http://purl.org/coar/access_right/c_abf2 |
| dc.subject.none.fl_str_mv | DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment |
| dc.title.fl_str_mv | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| dc.type.none.fl_str_mv | http://purl.org/coar/resource_type/c_efa0 |
| description | Objectives: To update the evidence for the efficacy and safety of (b)biological and (ts)targeted-synthetic disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League Against Rheumatism (ASAS/EULAR) recommendations for the management of axSpA. Methods: Systematic literature review (2009-2016) for randomised controlled trials (RCT), including longterm extensions, strategy trials and observational studies (the latter was only for safety assessment and a comparator was required). Interventions were any bDMARD or tsDMARD. All relevant efficacy and safety outcomes were included. Results: 76 papers and 24 abstracts fulfilled the inclusion criteria. Large treatment effects were found both in radiographic axSpA (r-axSpA) and nonradiographic axSpA (nr-axSpA) for all tumour necrosis factor inhibitors (TNFi) (NNT to achieve ASAS40 response ranged between 2.6-5.2 for r-axSpA and 2.3-5.4 for nr-axSpA). For nr-axSpA, efficacy was superior for those who had objective signs of inflammation ( positive C reactive protein or inflammation on MRI-SI). Secukinumab 150 mg has shown efficacy in two phase 3 RCTs (NNT to achieve ASAS40 response: 3.4 and 4.0). Ustekinumab and tofacitinib have shown positive results in phase 2/proof-of-concept trials; trials with apremilast, rituximab, interleukin (IL)-6 antagonists and abatacept have failed their primary end points. New (unknown) safety signals were not found in the trials but longterm observational safety data for TNFi are still scarce. Conclusions: New evidence supports the efficacy and safety of TNFi both in r-axSpA and nr-axSpA. Secukinumab is the first drug targeting the IL-17 pathway in r-axSpA that has shown efficacy. © Published by the BMJ Publishing Group Limited. |
| dirty | 0 |
| eu_rights_str_mv | openAccess |
| format | review |
| fulltext.url.fl_str_mv | https://run.unl.pt/bitstreams/0dd87fef-34f6-4c71-966e-d1d69f7136df/download |
| id | run_fbc7f1be4e6f7b667b8d3729d0533fbd |
| identifier.url.fl_str_mv | http://hdl.handle.net/10362/24127 |
| instacron_str | unl |
| institution | Universidade Nova de Lisboa |
| instname_str | Universidade Nova de Lisboa |
| language | eng |
| network_acronym_str | run |
| network_name_str | Repositório Institucional da UNL |
| oai_identifier_str | oai:run.unl.pt:10362/24127 |
| organization_str_mv | urn:organizationAcronym:unl |
| person_str_mv | Sepriano, A. Sepriano, Alexandre Sepriano, Alexandre https://www.ciencia-id.pt/5E1B-9976-5CE4 5E1B-9976-5CE4 http://orcid.org/0000-0003-1954-0229 0000-0003-1954-0229 Regel, A. Van Der Heijde, D. Braun, J. Baraliakos, X. Landewé, R. Van Den Bosch, F. Falzon, L. Ramiro, S. Ramiro, Sofia Ramiro, Sofia https://www.ciencia-id.pt/C513-D4F1-EEC3 C513-D4F1-EEC3 http://orcid.org/0000-0002-8899-9087 0000-0002-8899-9087 |
| publishDate | 2017 |
| reponame_str | Repositório Institucional da UNL |
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| spelling | engenObjectives: To update the evidence for the efficacy and safety of (b)biological and (ts)targeted-synthetic disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League Against Rheumatism (ASAS/EULAR) recommendations for the management of axSpA. Methods: Systematic literature review (2009-2016) for randomised controlled trials (RCT), including longterm extensions, strategy trials and observational studies (the latter was only for safety assessment and a comparator was required). Interventions were any bDMARD or tsDMARD. All relevant efficacy and safety outcomes were included. Results: 76 papers and 24 abstracts fulfilled the inclusion criteria. Large treatment effects were found both in radiographic axSpA (r-axSpA) and nonradiographic axSpA (nr-axSpA) for all tumour necrosis factor inhibitors (TNFi) (NNT to achieve ASAS40 response ranged between 2.6-5.2 for r-axSpA and 2.3-5.4 for nr-axSpA). For nr-axSpA, efficacy was superior for those who had objective signs of inflammation ( positive C reactive protein or inflammation on MRI-SI). Secukinumab 150 mg has shown efficacy in two phase 3 RCTs (NNT to achieve ASAS40 response: 3.4 and 4.0). Ustekinumab and tofacitinib have shown positive results in phase 2/proof-of-concept trials; trials with apremilast, rituximab, interleukin (IL)-6 antagonists and abatacept have failed their primary end points. New (unknown) safety signals were not found in the trials but longterm observational safety data for TNFi are still scarce. Conclusions: New evidence supports the efficacy and safety of TNFi both in r-axSpA and nr-axSpA. Secukinumab is the first drug targeting the IL-17 pathway in r-axSpA that has shown efficacy. © Published by the BMJ Publishing Group Limited.application/pdfenEfficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritisSepriano, A.PersonalSepriano, AlexandreDSpacehttp://dspace.org/items/d87df0c7-841b-4648-a99e-296348e2e286DSpacehttp://dspace.org/items/d87df0c7-841b-4648-a99e-296348e2e286SeprianoAlexandreCiência IDhttps://www.ciencia-id.pt5E1B-9976-5CE4ORCIDhttp://orcid.org0000-0003-1954-0229Scopus Author IDhttps://www.scopus.com55266526300Regel, A.Van Der Heijde, D.Braun, J.Baraliakos, X.Landewé, R.Van Den Bosch, F.Falzon, L.Ramiro, S.PersonalRamiro, SofiaDSpacehttp://dspace.org/items/9853406a-2641-440d-a8b1-a516bdb6f32fDSpacehttp://dspace.org/items/9853406a-2641-440d-a8b1-a516bdb6f32fRamiroSofiaCiência IDhttps://www.ciencia-id.ptC513-D4F1-EEC3ORCIDhttp://orcid.org0000-0002-8899-9087NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)BMJ Publishing GroupHostingInstitutionOrganizationalRUNe-mailmailto:run@unl.ptrun@unl.ptISSNIsPartOf2056-5933URNIsPartOfPURE: 3209505URNIsPartOfPURE UUID: b4cd2c92-7e19-4ed9-aaeb-6dd309202384URNIsPartOfRIS: urn:F1D488D5DC4B436016CA8E1305F592A3URNIsPartOfScopus: 85011031890URNIsPartOfPubMed: 28176964URNIsPartOfPubMedCentral: PMC5278329URNIsPartOfWOS: 000443681800021DOIIsPartOf10.1136/rmdopen-2016-0003962017-10-12T22:02:20Z2017-01-272017-01-27T00:00:00ZHandlehttp://hdl.handle.net/10362/24127http://purl.org/coar/access_right/c_abf2open accessDMARDs (biologic)DMARDs (synthetic)SpondyloarthritisTNF-alphaTreatment814966 bytesother research producthttp://purl.org/coar/resource_type/c_efa0reviewhttp://purl.org/coar/access_right/c_abf2application/pdffulltexthttps://run.unl.pt/bitstreams/0dd87fef-34f6-4c71-966e-d1d69f7136df/download |
| spellingShingle | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis Sepriano, A. DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment |
| status | SINGLETON |
| subject.fl_str_mv | DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment |
| title | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| title_full | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| title_fullStr | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| title_full_unstemmed | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| title_short | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| title_sort | Efficacy and safety of biological and targeted-synthetic DMARDs: A systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis |
| topic | DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment |
| topic_facet | DMARDs (biologic) DMARDs (synthetic) Spondyloarthritis TNF-alpha Treatment |
| url | http://hdl.handle.net/10362/24127 |
| visible | 1 |