Improvement or Worsening of Disease Activity After Switch to Sarilumab in Patients With Rheumatoid Arthritis With a Partial Response to Adalimumab

被引:2
作者
Curtis, Jeffrey [1 ]
Aletaha, Daniel [2 ]
Burmester, Gerd [3 ]
Ford, Kerri [4 ]
van Hoogstraten, Hubert [4 ]
Praestgaard, Amy P. [5 ]
Bykerk, Vivian [6 ]
机构
[1] Univ Alabama Birmingham, Div Clin Immunol & Rheumatol, Birmingham, AL 35205 USA
[2] Med Univ Vienna, Div Rheumatol, Vienna, Austria
[3] Charite Univ Med Berlin, Berlin, Germany
[4] Sanofi, Bridgewater, NJ USA
[5] Sanofi, Cambridge, MA USA
[6] Hosp Special Surg, New York, NY USA
关键词
rheumatoid arthritis; CDAI; adalimumab; sarilumab; swollen joint count; IMPORTANT-DIFFERENCE; INADEQUATE RESPONSE; BARRIERS; METHOTREXATE; PLACEBO;
D O I
10.1097/RHU.0000000000001946
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectiveThe aim of this study was to assess the effect of switching from adalimumab to sarilumab monotherapy in partial responders with rheumatoid arthritis from the MONARCH randomized trial and its open-label extension (OLE).MethodsPartial response was defined as improvement in Clinical Disease Activity Index (CDAI) of 12 or 6 units (baseline score: >22 or >10 and <= 22, respectively). Proportions of adalimumab partial responders with meaningful worsening or improvement at OLE weeks 12 and 24 were evaluated using 2 CDAI thresholds (>= 6 and >= 12 points), 28-joint Disease Activity Score using erythrocyte sedimentation rate (>= 0.6 and >= 1.2 points), Health Assessment Questionnaire Disability Index (>= 0.22 and >= 0.30 points), Simple Disease Activity Index (>= 7 and >= 13 points), physician and patient global assessments (>= 10 and >= 20), and 28-joint swollen and tender joint counts (>= 1 and >= 2 joints). Outcomes were analyzed using mixed-effect models with repeated measures for observed cases. The p values were produced using Wilcoxon tests.ResultsOf 369 enrolled patients, 320 (87%) entered the OLE and 155 switched from adalimumab to sarilumab; 59% (91/155) were partial responders. At week 24, 4%-17% and 2%-12% of partial responders experienced a worsening using the lower and higher thresholds, respectively, whereas 47%-78% and 27%-66% experienced improvement.ConclusionsPartial responders to adalimumab who switched to sarilumab had a low likelihood of experiencing meaningful worsening, with most patients showing meaningful improvement or no change in disease activity. This may help alleviate patients' fears of worsening when considering switching to a treatment with a different mechanism of action.
引用
收藏
页码:196 / 201
页数:6
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