Long-term Safety of Risankizumab From 17 Clinical Trials in Patients With Moderate-to-severe Plaque Psoriasis

K.B. Gordon; M. Lebwohl; K.A. Papp; H. Bachelez; J.J. Wu; R.G. Langley; A. Blauvelt; B. Kaplan; M. Shah; Y. Zhao; R. Sinvhal; K. Reich


The British Journal of Dermatology. 2022;186(3):466-475. 

In This Article

Abstract and Introduction


Background: Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.

Objectives: To evaluate safety data from risankizumab psoriasis phase I–III clinical trials.

Methods: Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I–III completed and ongoing trials.

Results: Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients.

Conclusions: Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.


Psoriasis is a chronic, systemic disease that has possible associations with psychiatric, arthritic, cardiometabolic and malignant comorbidities.[1,2] Most patients treated with biologic agents require continuous long-term treatment to achieve disease control.[3,4] Owing to the immunomodulatory nature of biologics, it has been suggested that patients treated with biologics may be more susceptible to opportunistic and other infections.[5]

Risankizumab is a selective interleukin (IL)-23 inhibitor[6] that binds to the p19 subunit of IL-23, preventing interaction with the IL-23 receptor. Risankizumab has been shown to be well tolerated and efficacious in patients with moderate-to-severe plaque psoriasis[3,7–9] and is approved for the treatment of moderate-to-severe plaque psoriasis in over 70 countries, including the USA, Canada, Japan and in Europe.[10,11] Here we report safety for up to 5·9 years of treatment with risankizumab using integrated data from 17 completed or ongoing clinical trials in plaque psoriasis.