University of Toronto and Sunnybrook Health Sciences Centre, 2075 Bayview Ave. Room M1-737, Toronto, ON, Canada, M4N 3M5.
Br J Dermatol. 2014 Sep;171(3):631-41. doi: 10.1111/bjd.13004. Epub 2014 Aug 13.
Tumour necrosis factor-α inhibitors, including infliximab (IFX), can improve disease control of plaque-type psoriasis.
The Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis (REALITY) study evaluated the efficacy and safety of maintenance IFX therapy in typical clinical settings.
In this prospective, observational, open-label, multicentre study in patients with plaque-type psoriasis, IFX 5 mg kg was infused at weeks 0, 2 and 6, and every 8 weeks thereafter during a 50-week treatment phase. The primary outcome was ≥ 75% Psoriasis Area and Severity Index (PASI) improvement from baseline to week 50. Patients with ≥ 25% PASI improvement from baseline to the end of the treatment phase were potentially eligible to enter a 48-week extended treatment phase. Response maintenance and other efficacy measures were evaluated. Adverse events (AEs) were collected.
In total 660 patients enrolled. Of 521 efficacy-evaluable treatment phase patients (66% male, mean age 46·5 years, mean PASI 18·1), 56·8% achieved PASI 75 at the end of the treatment phase. Response was maintained at week 50 by 64·7% (205/317) of patients who achieved PASI 75 at week 14. During extended treatment, 66·3% (112/169) of patients attained PASI 75 at week 98; response was maintained at week 98 by 71·6% (101/141) of those who achieved PASI 75 at week 50. IFX was generally well tolerated. During treatment, 7·6% (50/659) of patients had serious AEs. During extended treatment, 4·1% (eight of 193) of patients had serious AEs.
PASI 75 response was achieved by 56·8% and 66·3% of patients at weeks 50 and 98, respectively. The AE pattern was consistent with previous reports.
肿瘤坏死因子-α抑制剂，包括英夫利昔单抗（IFX），可以改善斑块型银屑病的疾病控制。
银屑病真实世界评估长期英夫利昔单抗治疗（REALITY）研究评估了维持 IFX 治疗在典型临床环境中的疗效和安全性。
在这项针对斑块型银屑病患者的前瞻性、观察性、开放标签、多中心研究中，IFX 5mg/kg 在第 0、2 和 6 周输注，此后每 8 周输注一次，共 50 周治疗期。主要终点是从基线到第 50 周时≥75%的银屑病面积和严重程度指数（PASI）改善。从基线到治疗结束时≥25%PASI 改善的患者有资格进入 48 周的扩展治疗期。评估了应答维持和其他疗效措施。收集了不良事件（AE）。
共纳入 660 例患者。在 521 例可评估疗效的治疗期患者中（66%为男性，平均年龄 46.5 岁，平均 PASI 为 18.1），56.8%的患者在治疗期末达到 PASI 75。在第 14 周达到 PASI 75 的 317 例患者中，有 64.7%（205/317）在第 50 周时维持了应答。在扩展治疗期间，169 例患者中有 66.3%（112/169）在第 98 周时达到 PASI 75；在第 50 周达到 PASI 75 的 141 例患者中，有 71.6%（101/141）在第 98 周时维持了应答。IFX 总体耐受性良好。在治疗期间，7.6%（50/659）的患者发生严重不良事件。在扩展治疗期间，193 例患者中有 4.1%（8/193）发生严重不良事件。
分别有 56.8%和 66.3%的患者在第 50 周和第 98 周时达到 PASI 75。AE 模式与以往报道一致。
