Division of Rheumatology and Clinical Immunology, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Orthopedics, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
Rheumatology (Oxford). 2021 Apr 6;60(4):1932-1941. doi: 10.1093/rheumatology/keaa685.
To evaluate the efficacy and safety of a step-down regimen of oral prednisolone over 24 weeks in patients of axial SpA (axSpA).
This proof-of-concept double-blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60, 40, 30, 20, 15 and 10 mg daily for 1 week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. The primary endpoint was a 50% improvement in the BASDAI (BASDAI50) at week 24. Analysis was intention to treat.
A BASDAI50 was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm at 24 weeks [difference 28.4% (95% CI 7.9, 46.7)]. However, there was no difference in achieving a 20 or 40% improvement in the Assessment of SpondyloArthritis international Society response between the groups. Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks. There was also no significant difference in ΔBASFI, ΔBAS-G or ΔBASMI at 12 or 24 weeks. No serious adverse events were noted. There was significant weight gain in the first 12 weeks in the prednisolone group vs placebo [0.9 (s.d. 0.4) kg], but not at 24 weeks.
In this small study, oral prednisolone was efficacious in axSpA in achieving the primary outcome, but many crucial secondary outcomes such as functional improvement were not met. Its impact on bone loss was not studied.Trial registration: CTRI/2018/01/011342.
评估 24 周口服泼尼松降阶梯方案治疗中轴型脊柱关节炎（axSpA）患者的疗效和安全性。
这是一项概念验证性、双盲、随机对照试验，纳入了活动性 axSpA（BASDAI≥4）、主要为轴性疾病（目前≤1 个活动关节）且对 NSAIDs 反应不足的患者。他们被随机分为两组，分别接受口服泼尼松（n=32）或安慰剂（n=33）治疗，剂量分别为 60、40、30、20、15 和 10mg/d，持续 1 周，随后分别接受 5mg/d 泼尼松（或安慰剂）治疗 18 周。主要终点是第 24 周时 BASDAI 改善 50%（BASDAI50）。分析为意向治疗。
泼尼松组 32 例患者中有 12 例（37.5%）和安慰剂组 33 例患者中有 3 例（9.1%）在第 24 周时达到 BASDAI50[差异 28.4%（95%CI 7.9，46.7%）]。然而，两组之间在达到 ASAS20 或 40 反应方面没有差异。尽管在第 24 周时，调整后的 BASDAI 和 CRP 时的 ASAS 反应评分的 ΔBASDAI 和 ΔAnkylosing Spondylitis Disease Activity Score 存在显著的组间差异，但在第 12 周时没有差异。在第 12 或 24 周时，BASFI、BAS-G 或 BASMI 的 ΔBASFI、BAS-G 或 BASMI 也没有显著差异。未观察到严重不良事件。在泼尼松组中，在第 12 周前体重显著增加（0.9（s.d.0.4）kg），但在第 24 周时没有增加。
在这项小型研究中，口服泼尼松在 axSpA 中达到了主要结局，但许多关键的次要结局，如功能改善，都没有达到。其对骨丢失的影响尚未研究。
CTRI/2018/01/011342。
