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dc.contributor.authorSieper, Joachim
dc.contributor.authorBraun, Jurgen
dc.contributor.authorKay, Jonathan
dc.contributor.authorBadalamenti, Salvatore
dc.contributor.authorRadin, Allen R.
dc.contributor.authorJiao, Lixia
dc.contributor.authorFiore, Stefano
dc.contributor.authorMomtahen, Tanya
dc.contributor.authorYancopoulos, George D.
dc.contributor.authorStahl, Neil
dc.contributor.authorInman, Robert D.
dc.date2022-08-11T08:10:51.000
dc.date.accessioned2022-08-23T17:22:17Z
dc.date.available2022-08-23T17:22:17Z
dc.date.issued2014-02-18
dc.date.submitted2015-04-17
dc.identifier.citationAnn Rheum Dis. 2014 Feb 18. doi: 10.1136/annrheumdis-2013-204963. <a href="http://dx.doi.org/10.1136/annrheumdis-2013-204963">Link to article on publisher's site</a>
dc.identifier.issn0003-4967 (Linking)
dc.identifier.doi10.1136/annrheumdis-2013-204963
dc.identifier.pmid24550171
dc.identifier.urihttp://hdl.handle.net/20.500.14038/48713
dc.description.abstractOBJECTIVES: The ALIGN study (NCT01061723) evaluated the efficacy and safety of sarilumab, the first fully human monoclonal antibody against interleukin-6 receptor-alpha (IL-6Ralpha), in patients with ankylosing spondylitis (AS). METHODS: Patients with active AS despite conventional treatment were randomised to placebo, or one of five subcutaneous dose regimens of sarilumab (100, 150 or 200 mg every other week, or 100 or 150 mg every week), for 12 weeks. The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society (ASAS) 20 response criteria at week 12. Secondary endpoints included ASAS40 response, ASAS partial remission, AS Disease Activity Score, high-sensitivity C-reactive protein (hs-CRP) value, and safety. RESULTS: Baseline demographic and disease characteristics of the 301 patients enrolled were similar across treatment groups. At week 12, there was no statistically significant difference in ASAS20 response rate between placebo (ASAS20 = 24.0%) and any sarilumab dose group. A significantly greater reduction in hs-CRP value was achieved with the higher sarilumab doses versus placebo. No other statistically significant differences were evident for secondary efficacy endpoints.The most common treatment-emergent adverse events reported for sarilumab included infections (non-serious), neutropenia, and increase in alanine aminotransferase. No cases of tuberculosis, opportunistic, or fungal infections, or bowel perforations were reported. Seven patients experienced a treatment-emergent serious adverse event (all in sarilumab treatment groups). No deaths occurred. CONCLUSIONS: The ALIGN study shows that IL-6Ralpha blockade with sarilumab was not an effective treatment for AS. Sarilumab was generally well tolerated with a manageable safety profile.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=24550171&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1136/annrheumdis-2013-204963
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/
dc.subjectsarilumab
dc.subjectankylosing spondylitis
dc.subjectMusculoskeletal Diseases
dc.subjectRheumatology
dc.subjectSkin and Connective Tissue Diseases
dc.titleSarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN)
dc.typeJournal Article
dc.source.journaltitleAnnals of the rheumatic diseases
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=1108&amp;context=rheumatology_pubs&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/rheumatology_pubs/109
dc.identifier.contextkey7002936
refterms.dateFOA2022-08-23T17:22:18Z
html.description.abstract<p>OBJECTIVES: The ALIGN study (NCT01061723) evaluated the efficacy and safety of sarilumab, the first fully human monoclonal antibody against interleukin-6 receptor-alpha (IL-6Ralpha), in patients with ankylosing spondylitis (AS).</p> <p>METHODS: Patients with active AS despite conventional treatment were randomised to placebo, or one of five subcutaneous dose regimens of sarilumab (100, 150 or 200 mg every other week, or 100 or 150 mg every week), for 12 weeks. The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society (ASAS) 20 response criteria at week 12. Secondary endpoints included ASAS40 response, ASAS partial remission, AS Disease Activity Score, high-sensitivity C-reactive protein (hs-CRP) value, and safety.</p> <p>RESULTS: Baseline demographic and disease characteristics of the 301 patients enrolled were similar across treatment groups. At week 12, there was no statistically significant difference in ASAS20 response rate between placebo (ASAS20 = 24.0%) and any sarilumab dose group. A significantly greater reduction in hs-CRP value was achieved with the higher sarilumab doses versus placebo. No other statistically significant differences were evident for secondary efficacy endpoints.The most common treatment-emergent adverse events reported for sarilumab included infections (non-serious), neutropenia, and increase in alanine aminotransferase. No cases of tuberculosis, opportunistic, or fungal infections, or bowel perforations were reported. Seven patients experienced a treatment-emergent serious adverse event (all in sarilumab treatment groups). No deaths occurred.</p> <p>CONCLUSIONS: The ALIGN study shows that IL-6Ralpha blockade with sarilumab was not an effective treatment for AS. Sarilumab was generally well tolerated with a manageable safety profile.</p>
dc.identifier.submissionpathrheumatology_pubs/109
dc.contributor.departmentDepartment of Medicine, Division of Rheumatology


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