Department of Clinical Dermatology, Centre for the Study and Treatment of Psoriasis, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.
Scientific Direction, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.
J Dermatolog Treat. 2020 Nov;31(7):687-691. doi: 10.1080/09546634.2019.1606886. Epub 2019 May 1.
Currently, there are no studies specifically aimed at investigating the effectiveness of etanercept biosimilar SB4 in psoriatic arthritis (PsA). Our primary objective was to verify the ability of SB4 to maintain low disease activity in patients switching from reference etanercept to SB4 after 1 year of treatment with this last drug. Eighty-seven PsA patients with low disease activity at baseline measured by using the clinical Disease Activity Index for Psoriatic Arthritis ≤ 13 (cDAPSA; range 0-154) were prospectively evaluated after 6 and 12 months when switching from the reference etanercept to SB4. One year after switching from the reference etanercept to SB4, 76 (87.3%) out of 87 patients maintained a cDAPSA ≤ 13. SB4 was effective in maintaining a state of low disease activity in the majority of patients switched from the reference etanercept. However, the proportion of patients (11 subjects) who failed to maintain a state of low disease activity at the end of the study was statistically significant. Loss of effectiveness in the above subjects was mainly due to subjective evaluations given by the patients, rather than an objectifiable exacerbation of disease.
目前，尚无专门针对评估依那西普生物类似药 SB4 在银屑病关节炎（PsA）中疗效的研究。我们的主要目的是验证 SB4 在参考依那西普治疗 1 年后，对患者从参考依那西普转换为 SB4 时维持低疾病活动的能力。87 例基线时用银屑病关节炎临床疾病活动指数（cDAPSA；范围 0-154）评估为低疾病活动的 PsA 患者，在开始转换为 SB4 后第 6 个月和第 12 个月进行前瞻性评估。从参考依那西普转换为 SB4 1 年后，87 例患者中有 76 例（87.3%）cDAPSA≤13。SB4 可有效维持大多数从参考依那西普转换的患者的低疾病活动状态。然而，在研究结束时，未能维持低疾病活动状态的患者比例（11 例）具有统计学意义。上述患者的疗效丧失主要是由于患者的主观评估，而不是疾病客观加重。
