Rheumatology Unit, Arcispedale Santa Maria Nuova, I.R.C.C.S, Reggio Emilia, Italy.
Clin Exp Rheumatol. 2014 Jul-Aug;32(4):460-4. Epub 2014 Jun 23.
Tocilizumab (TCZ) is an effective treatment in patients with rheumatoid arthritis (RA) refractory to anti-tumour necrosis factor-α. However, only few studies in real life have evaluated the efficacy of TCZ in long-standing rheumatoid arthritis (LSRA). Our aim was to evaluate the efficacy and safety of tocilizumab in refractory LSRA.
Twenty-seven consecutive patients with refractory LSRA treated with at least one biologic agent were enrolled in a 19-month study in a single centre. Demographic [age, gender, disease duration, body mass index (BMI), previous therapies], clinical [total swollen and tender joints count (SJC-TJC) on 28, 44 and 68 joints, DAS28, Health Assessment Questionnaire (HAQ), infections, cardiovascular, renal, pulmonary and metabolic comorbidities], and serological [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), anti-cyclic citrullinated peptide (anti-CCP) antibodies] data were collected. Patients were evaluated at baseline, and after three and six months.
Mean disease duration was 16.75±9.94 years. Seventeen out of 27 (62.9%) were RF positive and 13/27 (48.1%) were CCP positive. All of them experienced at least one previous biological agent (mean value 1.9±1.15; range 1-6). We observed a progressive reduction in all clinical and clinimetric features evaluated as well as a progressive reduction in steroids use. The EULAR response also improved. By analysing the RF positive subgroup we found that there is a better clinical response both at the 3rd and 6th month.
TCZ is an effective and safe treatment in refractory LSRA.
托珠单抗（TCZ）是治疗肿瘤坏死因子-α（TNF-α）拮抗剂治疗抵抗的类风湿关节炎（RA）的有效药物。然而，仅有少数真实世界研究评估了 TCZ 在长期 RA（LSRA）中的疗效。我们的目的是评估 TCZ 在难治性 LSRA 中的疗效和安全性。
在单中心的 19 个月研究中，共纳入 27 例难治性 LSRA 患者，他们至少接受过一种生物制剂治疗。收集人口统计学[年龄、性别、疾病持续时间、体重指数（BMI）、既往治疗]、临床[28、44 和 68 个关节的总肿胀和压痛关节数（SJC-TJC）、DAS28、健康评估问卷（HAQ）、感染、心血管、肾脏、肺部和代谢合并症]和血清学[红细胞沉降率（ESR）、C 反应蛋白（CRP）、类风湿因子（RF）、抗环瓜氨酸肽（抗-CCP）抗体]数据。患者在基线、治疗后 3 个月和 6 个月进行评估。
平均疾病持续时间为 16.75±9.94 年。27 例患者中 17 例（62.9%）RF 阳性，13 例（48.1%）抗-CCP 阳性。他们均至少接受过一种生物制剂治疗（平均值 1.9±1.15；范围 1-6）。我们观察到所有评估的临床和临床计量特征均逐渐改善，且类固醇用量逐渐减少。EULAR 反应也得到改善。通过分析 RF 阳性亚组，我们发现第 3 个月和第 6 个月的临床反应更好。
TCZ 是治疗难治性 LSRA 的有效且安全的药物。
