July 2024

Risankizumab induction therapy achieves early symptom improvements that are associated with future clinical and endoscopic outcomes in Crohn's disease: Post hoc analysis of the ADVANCE, MOTIVATE, and FORTIFY Phase 3 studies

J Crohns Colitis 2024;18:818–27 doi: 10.1093/ecco-jcc/jjad206

This post hoc analysis provides additional support for the utility of risankizumab therapy in patients with moderately to severely active CD. Investigators examined the efficacy of risankizumab for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints.

Keywords:

June 2024

Enthesitis and dactylitis resolution with risankizumab for active psoriatic arthritis: Integrated analysis of the randomized KEEPsAKE 1 and 2 Trials

Dermatol Ther 2024;14:1517–1530 doi: 10.1007/s13555-024-01174-4

Kwatra et al. found that risankizumab significantly improves clinical signs and symptoms of enthesitis and/or dactylitis in PsA patients, with substantial and sustained efficacy observed up to 52 weeks. Furthermore, these improvements were met by meaningful gains in patient reported outcomes.

Keywords:

Maintenance risankizumab sustains induction response in patients with Crohn’s disease in a randomized Phase 3 trial

J Crohns Colitis 2024;18:416–423 doi: 10.1093/ecco-jcc/jjad168

Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over one year in patients with moderately to severely active Crohn’s disease. Endpoint achievement tended to be achieved in a higher proportion of patients treated with 360mg risankizumab than 160mg risankizumab, and both doses were higher when compared to placebo.

Keywords:

May 2024

Adverse events with risankizumab in the real world: Postmarketing pharmacovigilance assessment of the FDA adverse event reporting system

Front Immunol 2023;14:1169735 DOI 10.3389/fimmu.2023.1169735 Epub ahead of print

Shu, et al. identified 37 preferred terms as unexpected AEs following risankizumab treatment, and found 48 AEs with an increased risk of risankizumab-induced AE severity. They also identified that risankizumab signal strengths were significantly higher in eight system organ classes.

Keywords:

Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal Phase 3 FORTIFY maintenance trial

Lancet 2022;399:2031–36 doi: 10.1016/S0140-6736(22)00466-4

Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.

Keywords:

Risankizumab as induction therapy for Crohn’s disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials

Lancet 2022;399:2015–30 doi 10.1016/S0140-6736(22)00467-6

Risankizumab was effective and well tolerated as induction therapy in patients with moderately to severely active Crohn’s disease, though there were no significant differences in efficacy between 600mg and 1200mg doses.

Keywords:

April 2024

Real-world effectiveness of risankizumab in patients with moderate-to-severe psoriasis using the CorEvitas Psoriasis Registry

J Am Acad Dermatol 2024;90:82–90 doi: 10.1016/j.jaad.2023.08.097

The majority of patients receiving persistent risankizumab therapy achieved clear or clear/almost clear skin at 12 months and patients reported significant reductions in DLQI scores, PROs (fatigue, skin pain, overall itch), and work and activity impairment.

Keywords:

Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the Phase 3 KEEPsAKE1 randomized clinical trial

Rheumatol Ther 2024 doi: 10.1007/s40744-024-00654-5 Epub ahead of print

Risankizumab therapy was associated with significant and sustained improvement in multiple disease domains from Week 52 through Week 100, compared with placebo. Kristensen et al. investigated the safety, efficacy and tolerability of 100-week risankizumab therapy in PsA patients with previous inadequate response to ≥1 csDMARD, using data from KEEPsAKE 1 trial.

Keywords:

Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): A randomised, double-blind, active-comparator-controlled Phase 3 trial

Lancet 2019;394:576–86. doi: 10.1016/S0140-6736(19)30952-3

Treatment with risankizumab showed significantly greater efficacy over adalimumab in providing substantial skin clearance in patients with moderate-to-severe chronic plaque PsO. This study aimed to assess the safety and efficacy of risankizumab compared with adalimumab in an active-comparator Phase 3 trial.

Keywords:

Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis: A Phase 3 randomized clinical trial

JAMA Dermatol 2020;156:649–58. doi 10.1001/jamadermatol.2020.0723

Blauvelt et al. shows superior and sustained efficacy for risankizumab in maintaining skin clearance over time versus placebo upon withdrawal, alongside a favourable safety profile in chronic plaque psoriasis through a phase 3, randomised, double-blind, placebo-controlled study, assessing PASI 90 and sPGA score of 0/1 at Week 16.

Keywords: