First Department of Propedeutic and Internal Medicine, Laikon Hospital, Athens University Medical School, Athens, Greece.
J Rheumatol. 2011 Nov;38(11):2466-74. doi: 10.3899/jrheum.110242. Epub 2011 Sep 1.
To assess the efficacy and safety of adalimumab or cyclosporine (CYC) as monotherapy or combination therapy for patients with active psoriatic arthritis (PsA), despite methotrexate (MTX) therapy.
A prospective 12-month, nonrandomized, unblinded clinical trial of 57, 58, and 55 patients who received CYC (2.5-3.75 mg/kg/day), adalimumab (40 mg every other week), or combination, respectively. Lowering of concomitant nonsteroidal antiinflammatory drugs (NSAID) and corticosteroids and reductions of adalimumab and/or CYC doses in responding patients were not restricted.
Mean numbers of tender/swollen joints at baseline were 9.7/6.7 in CYC-treated, 13.0/7.8 in adalimumab-treated, and 14.5/9.4 in combination-treated patients, indicating lesser disease severity of patients assigned to the first group. The Psoriatic Arthritis Response Criteria at 12 months were met by 65% of CYC-treated (p = 0.0003 in favor of combination treatment), 85% of adalimumab-treated (p = 0.15 vs combination treatment), and 95% of combination-treated patients, while the American College of Rheumatology-50 response rates were 36%, 69%, and 87%, respectively (p < 0.0001 and p = 0.03 in favor of combination treatment). A significantly greater mean improvement in Health Assessment Questionnaire Disability Index was achieved by combination treatment (-1.11) vs CYC (-0.41) or adalimumab alone (-0.85). Combination therapy significantly improved Psoriasis Area and Severity Index-50 response rates beyond adalimumab, but not beyond the effect of CYC monotherapy. Doses of NSAID and corticosteroids were reduced in combination-treated patients; CYC doses and frequency of adalimumab injections were also reduced in 51% and 10% of them, respectively. No new safety signals were observed.
The combination of adalimumab and CYC is safe and seemed to produce major improvement in both clinical and serological variables in patients with severely active PsA and inadequate response to MTX.
评估阿达木单抗或环孢素（CYC）作为单药或联合治疗药物，用于治疗甲氨蝶呤（MTX）治疗后仍处于活动期的银屑病关节炎（PsA）患者的疗效和安全性。
这是一项前瞻性、12 个月、非随机、非盲的临床试验，共纳入 57、58 和 55 名患者，分别接受 CYC（2.5-3.75mg/kg/天）、阿达木单抗（40mg 每两周一次）或联合治疗。未限制应答患者降低伴随使用的非甾体抗炎药（NSAID）和皮质类固醇药物以及降低阿达木单抗和/或 CYC 的剂量。
在接受 CYC 治疗的患者中，基线时压痛/肿胀关节的平均数量为 9.7/6.7，接受阿达木单抗治疗的患者为 13.0/7.8，接受联合治疗的患者为 14.5/9.4，表明第一组患者的疾病严重程度较轻。在 12 个月时，接受 CYC 治疗的患者中有 65%（p=0.0003，与联合治疗相比）、接受阿达木单抗治疗的患者中有 85%（p=0.15，与联合治疗相比）和接受联合治疗的患者中有 95%达到了银屑病关节炎反应标准，而美国风湿病学会 50 应答率分别为 36%、69%和 87%（p<0.0001，p=0.03，与联合治疗相比）。与 CYC（-0.41）或阿达木单抗（-0.85）单药治疗相比，联合治疗组的健康评估问卷残疾指数（Health Assessment Questionnaire Disability Index）平均改善幅度更大（-1.11）。联合治疗在改善银屑病面积和严重程度指数-50 应答率方面明显优于阿达木单抗，但与 CYC 单药治疗相比没有进一步提高。联合治疗组的 NSAID 和皮质类固醇剂量减少；51%和 10%的患者也分别减少了 CYC 剂量和阿达木单抗注射频率。未观察到新的安全性信号。
阿达木单抗和 CYC 的联合治疗是安全的，似乎能显著改善对 MTX 反应不足的严重活动期 PsA 患者的临床和血清学指标。
