Oregon Medical Research Center, Portland, OR, USA.
Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.
J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.
Risankizumab is approved for treatment of moderate to severe plaque psoriasis. Availability of a patient-controlled single self-injection of risankizumab may improve adherence and long-term management of psoriasis.
To investigate efficacy, safety, and usability of a new risankizumab 150 mg/mL formulation administered as a single subcutaneous injection via prefilled syringe (PFS) or autoinjector (AI).
Efficacy, safety, usability, and acceptability of risankizumab 150 mg/mL PFS or AI were investigated in adults with moderate to severe psoriasis in two phase 3 studies. Study 1 was a multicenter, randomized, double-blinded, placebo-controlled study that investigated 150 mg/mL risankizumab PFS; study 2 was a multicenter, single-arm, open-label study that investigated 150 mg/mL risankizumab AI.
At week 16, risankizumab 150 mg/mL demonstrated efficacy vs. placebo (Psoriasis Area and Severity Index ≥90% improvement (PASI 90), 62.9% vs. 3.8%; static Physician Global Assessment (sPGA) 0/1, 78.1% vs. 9.6%; both < .001) in study 1; in study 2, PASI 90 and sPGA 0/1 were 66.7%, and 81.5%, respectively. All patients successfully self-administered study treatments via PFS or AI. Acceptability of self-injection was high in both studies. Efficacy and safety of risankizumab 150 mg/mL were comparable with results from previous risankizumab phase 3 studies using the 90 mg/mL formulation.
The efficacy, safety, and usability of 150 mg/mL risankizumab delivered as a single PFS or AI injection support use of this new formulation in patients with moderate to severe plaque psoriasis.
NCT03875482 and NCT0387508.
里莎鲁单抗获批用于治疗中重度斑块型银屑病。患者自控单次皮下注射里莎鲁单抗的方式可能会提高患者对银屑病的长期管理和治疗的依从性。
评估新的 150mg/ml 里莎鲁单抗制剂作为预充式注射器（PFS）或自动注射器（AI）单次皮下注射的疗效、安全性和易用性。
两项 3 期研究评估了中重度斑块型银屑病成年患者使用 150mg/ml 里莎鲁单抗 PFS 或 AI 的疗效、安全性、易用性和可接受性。研究 1 为多中心、随机、双盲、安慰剂对照研究，评估了 150mg/ml 里莎鲁单抗 PFS；研究 2 为多中心、单臂、开放标签研究，评估了 150mg/ml 里莎鲁单抗 AI。
在第 16 周，与安慰剂相比，150mg/ml 里莎鲁单抗 PFS 达到了以下疗效终点（PASI90 改善≥90%，62.9% vs. 3.8%；静态医师整体评估（sPGA）0/1，78.1% vs. 9.6%；均<0.001）；在研究 2 中，PASI90 和 sPGA0/1 分别为 66.7%和 81.5%。所有患者均成功通过 PFS 或 AI 进行自我治疗。两项研究中，自我注射的接受度均较高。与使用 90mg/ml 制剂的既往里莎鲁单抗 3 期研究结果相比，150mg/ml 里莎鲁单抗的疗效和安全性相当。
150mg/ml 里莎鲁单抗 PFS 或 AI 单次给药的疗效、安全性和易用性支持该新制剂在中重度斑块型银屑病患者中的应用。
NCT03875482 和 NCT0387508。
