Smolen Josef S, Han Chenglong, van der Heijde Désirée, Emery Paul, Bathon Joan M, Keystone Edward, Kalden Joachim R, Schiff Michael, Bala Mohan, Baker Daniel, Han John, Maini Ravinder N, St Clair E William
Medical University of Vienna and Lainz Hospital, Vienna, Austria.
Arthritis Rheum. 2006 Mar;54(3):716-22. doi: 10.1002/art.21661.
To evaluate the impact of infliximab therapy on the employment status of patients with early rheumatoid arthritis (RA).
Methotrexate (MTX)-naive patients with active early RA were randomly allocated to receive MTX plus placebo or MTX plus infliximab (3 mg/kg or 6 mg/kg) at weeks 0, 2, and 6 and then every 8 weeks through week 46. Data for patients younger than age 65 years were included in the analyses. A patient was categorized as employable if he or she was employed or felt well enough to work if a job were available.
The change in actual employment was not significantly different between patients receiving MTX plus infliximab and those receiving MTX plus placebo (0.5% versus 1.3%; P > 0.5). However, the proportion of patients whose status changed from employable at baseline to unemployable at week 54 was smaller in the group receiving MTX plus infliximab compared with that in the group receiving MTX alone (8% versus 14%; P = 0.05). Patients who were treated with infliximab plus MTX had a significantly greater likelihood of improvement rather than deterioration in employability (odds ratio 2.4; P < 0.001); this likelihood was not significantly greater in patients receiving MTX alone. The proportion of employed patients who lost workdays during the trial was smaller in the MTX plus infliximab group than in the MTX-alone group (P = 0.010).
The actual employment rates among patients in the 2 treatment groups were not different. However, patients with early RA who were treated with MTX plus infliximab had a higher probability of maintaining their employability compared with those who were treated with MTX alone.
评估英夫利昔单抗治疗对早期类风湿关节炎(RA)患者就业状况的影响。
初治甲氨蝶呤(MTX)的活动性早期RA患者被随机分配,在第0、2和6周接受MTX加安慰剂或MTX加英夫利昔单抗(3mg/kg或6mg/kg)治疗,然后每8周一次,直至第46周。分析纳入年龄小于65岁患者的数据。若患者受雇,或虽未受雇但感觉身体状况良好足以胜任工作,则将其归类为有就业能力。
接受MTX加英夫利昔单抗治疗的患者与接受MTX加安慰剂治疗的患者相比,实际就业情况的变化无显著差异(0.5%对1.3%;P>0.5)。然而,与仅接受MTX治疗的组相比,接受MTX加英夫利昔单抗治疗的组中,在基线时有就业能力而在第54周变为无就业能力的患者比例更小(8%对14%;P = 0.05)。接受英夫利昔单抗加MTX治疗的患者就业能力改善而非恶化的可能性显著更高(优势比2.4;P<0.001);仅接受MTX治疗的患者这一可能性无显著增加。在试验期间失去工作日的受雇患者比例,MTX加英夫利昔单抗组低于MTX单药组(P = 0.010)。
两个治疗组患者的实际就业率无差异。然而,与仅接受MTX治疗的早期RA患者相比,接受MTX加英夫利昔单抗治疗的患者维持就业能力的概率更高。