Long-Term Safety and Efficacy of Risankizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Results from a Phase 2 Open-Label Extension Trial

Kim A Papp, Saskia de Vente, Jiewei Zeng, Mary Flack, Byron Padilla, Stephen K Tyring, Kim A Papp, Saskia de Vente, Jiewei Zeng, Mary Flack, Byron Padilla, Stephen K Tyring

Abstract

Introduction: Although many biologic therapies are effective for clearing skin of patients with psoriasis, some lose effectiveness over time. This phase 2 open-label extension (OLE) trial was designed to investigate the long-term safety and efficacy of risankizumab.

Methods: In the phase 2, double-blind, active comparator, predecessor trial (NCT02054481), patients with moderate-to-severe chronic plaque psoriasis were treated for 24 weeks with subcutaneous (SC) risankizumab or ustekinumab, followed by a 24-week follow-up without treatment administration. Patients could enroll in the OLE (NCT02203851) when they experienced loss of treatment response (< 50% improvement in the Psoriasis Area Severity Index [PASI 50]) during follow-up) or at the end of follow-up if treatment response was ongoing. In the OLE, patients were treated every 12 weeks for at least 48 weeks with SC risankizumab 90 or 180 mg, beginning at week 12 (OLE visit 2), if the patient had not achieved PASI 90. Efficacy endpoints included the proportions of patients who achieved PASI 50/75/90/100 and static Physician's Global Assessment (sPGA) of clear or almost clear skin at week 48 (sPGA 0/1; OLE visit 5).

Results: Of the 110 enrolled patients, 99 (90.0%) completed the OLE. No patients discontinued the study because of adverse events. At week 48, 74.1% of patients achieved PASI 90, whereas 98.1, 91.7, 53.7, and 67.6% achieved PASI 50/75/100 and sPGA 0/1, respectively. All efficacy results were consistent or slightly increased at OLE week 48 compared with week 12. No new safety findings were observed.

Conclusion: Risankizumab treatment was well tolerated with sustained clinical efficacy for at least 48 weeks.

Trial registration: ClinicalTrials.gov identifier; NCT02203851.

Keywords: Biologic therapy; Interleukin-23; Open-label extension; Psoriasis; Risankizumab.

Figures

Fig. 1
Fig. 1
Patient disposition. OLE Open-label extension, UST ustekinumab. Full details on patient disposition in the double-blind portion have been published elsewhere [21]
Fig. 2
Fig. 2
Efficacy outcomes. Graphs show results for PASI 90 (a), PASI 100 (b), PASI 75 (c), PASI 50 (d), and sPGA of clear or almost clear skin (sPGA 0/1) (e) over time and by treatment received in the predecessor study. PASI50, 75, 90, 100 Psoriasis Area and Severity Index ≥ 50, 75, 90 and 100%, respectively, improvement from baseline, sPGA static Physician’s Global Assessment. Of the 110 patients, 23 switched to risankizumab 180 mg at week 12 (OLE visit 2)

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