Norvang Vibeke, Sexton Joseph, Kristianslund Eirik K, Olsen Inge C, Uhlig Till, Bakland Gunnstein, Krøll Frode, Rødevand Erik, Wierød Ada, Kvien Tore K, Smolen Josef S, Aletaha Daniel, Haavardsholm Espen A
Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Institute of Health and Society, University of Oslo, Oslo, Norway.
RMD Open. 2018 Oct 26;4(2):e000773. doi: 10.1136/rmdopen-2018-000773. eCollection 2018.
When initiating a new therapy in patients with rheumatoid arthritis (RA), current treatment recommendations suggest escalating therapy in case of poor clinical improvement by 3 months or if the treatment target has not been reached by 6 months. We investigated which disease activity improvement levels at 3 months predicted achievement of the treatment targets at 6 months in a real-life clinical setting.
We included 1610 patients with RA enrolled in the NOR-DMARD study between 2000 and 2012. Analyses were performed for the total group of patients and repeated for subgroups stratified by baseline disease activity, disease duration or treatment with methotrexate or a tumour necrosis factor inhibitor. We used a diagnostic test approach to explore the associations between 3-month response and 6-month outcome.
Not achieving 50% improvement in Simplified Disease Activity Index (SDAI) by 3 months significantly decreased the likelihood of reaching remission at 6 months in all subgroups (negative likelihood ratios (LRs-) 0.15-0.36). Patients with high disease activity when initiating treatment were likely to fail reaching remission if they achieved less than SDAI 70% response by 3 months (LR- 0.25 and negative predictive value 0.98). Achieving a major response (SDAI 85%) at 3 months significantly increased the likelihood of reaching remission at 6 months (LRs+ 6.56).
Levels of 3-month disease activity improvement can inform clinicians when deciding to continue or adjust ongoing therapy in a treat-to-target strategy aiming for remission or low disease activity within 6 months. The required levels of 3-month improvement varied with baseline disease activity.
在类风湿关节炎(RA)患者开始新治疗时,当前治疗建议表明,若3个月时临床改善不佳或6个月时未达到治疗目标,则应加强治疗。我们调查了在实际临床环境中,3个月时哪种疾病活动改善水平可预测6个月时治疗目标的达成情况。
我们纳入了2000年至2012年间参加NOR-DMARD研究的1610例RA患者。对所有患者进行分析,并按基线疾病活动度、病程或是否使用甲氨蝶呤或肿瘤坏死因子抑制剂进行亚组分层后重复分析。我们采用诊断试验方法来探究3个月反应与6个月结局之间的关联。
3个月时简化疾病活动指数(SDAI)改善未达50%,在所有亚组中均显著降低了6个月时达到缓解的可能性(阴性似然比(LR-)为0.15 - 0.36)。开始治疗时疾病活动度高的患者,如果3个月时SDAI反应低于70%,则很可能无法达到缓解(LR-为0.25,阴性预测值为0.98)。3个月时达到主要反应(SDAI 85%),显著增加了6个月时达到缓解的可能性(LR+为6.56)。
在以6个月内达到缓解或低疾病活动度为目标的达标治疗策略中,3个月疾病活动改善水平可为临床医生决定继续或调整当前治疗提供参考。3个月所需的改善水平因基线疾病活动度而异。