For Psoriasis, Risankizumab Has Best Long-Term Risk-Benefit Profile

Randomized controlled trials (RCTs) suggest that risankizumab features the most favorable long-term benefit-risk profile compared with other anti-interleukin 23 (anti-IL-23) agents for the treatment of moderate to severe plaque psoriasis. This is according to a meta-analysis of studies published in the Journal of the American Academy of Dermatology.

A team of North American and Italian researchers performed a systematic literature review of phase 2 through 4 RCTs that studied the use of different therapies for moderate to severe plaque psoriasis. The researchers examined rates of adverse events (AEs), any serious AEs (SAEs), and AEs that led to treatment discontinuation in adult participants in these trials. Safety endpoints were compared between treatment groups using Bayesian network meta-analyses.

A total of 52 RCTs were included in short-term network meta-analyses, and 7 RCTs were included in long-term network meta-analyses.

In the short-term network meta-analyses, rates of any AEs were lower with tildrakizumab (46.0% for 200 mg q12w; 95% CrI, 39.2% to 52.9%), certolizumab (46.2% for 200 mg q2w; 95% CrI, 37.0% to 55.5%), and etanercept (49.1%; 95% CrI, 35.5% to 62.9%). Short-term network meta-analyses of any SAE revealed therapies associated with the lowest rates included certolizumab (0.8%; 95% CrI, 0.2% to 3.0%), risankizumab (1.2%; 95% CrI, 0.6% to 2.4%), and etanercept (1.6%; 95% CrI, 0.3% to 7.5%).

Across 45 trials, rates of treatment discontinuation due to AEs were lowest for risankizumab (0.5%; 95% CrI, 0.2% to 1.3%), tildrakizumab (1.0%; 95% CrI, 0.2% to 4.4%), and guselkumab (1.5%; 95% CrI, 0.7% to 3.1%).

In the benefit-risk assessment for long-term outcomes, risankizumab consistently featured the highest efficacy and lowest rates of AEs (67.5%; 95% CrI, 57.8% to 75.6%), any SAEs (4.4%; 95% CrI, 2.4% to 8.1%), and AEs that led to treatment discontinuation (1.0%; 95% CrI, 0.2% to 4.1%).

A limitation of this meta-analysis was the inclusion of populations involved in RCTs that the investigators suggest may not be representative overall of the real-world patient population.

The investigators concluded that risankizumab offers “the most favorable benefit-risk profile in the long term.”

Disclosure: This clinical trial was supported by AbbVie. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Shear NH, Betts KA, Soliman AM, et al. Comparative safety and benefit-risk profile of biologics and oral treatments for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data. J Am Acad Dermatol. Published online February 22, 2021. doi:10.1016/j.jaad.2021.02.057