KEEPsAKE-1: Risankizumab Maintains Radiographic Nonprogression Through 5 Years in Psoriatic Arthritis

Nearly 9 in 10 patients with biologic-naïve psoriatic arthritis (PsA) treated with risankizumab (Skyrizi; AbbVie) showed no radiographic progression over approximately 5 years of follow-up, according to a post hoc analysis of the phase 3 KEEPsAKE 1 trial presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting held in Denver, Colorado, from March 27-31.¹

The findings extend the radiographic dataset for risankizumab in PsA to 244 weeks, marking the longest such follow-up reported from the KEEPsAKE program, and reinforce prior evidence of durable structural protection in this population.

KEEPsAKE 1 Study

KEEPsAKE 1 (NCT03675308) is a phase 3, randomized, double-blind study of risankizumab 150 mg versus placebo in adults with active PsA and inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD). After an initial 24-week double-blind period, all patients entered an open-label extension receiving risankizumab 150 mg every 12 weeks through week 316.¹

In the current post hoc analysis, investigator Sarah Lonowski, MD, MBA, Assistant Professor, UNMC Department of Dermatology, and colleagues, focused on the n = 483 patients initially randomized to risankizumab, tracking radiographic outcomes assessed by the modified Total Sharp Score (mTSS) — a composite measure of joint erosion and joint space narrowing in the hands, wrists, and feet, scored from 0 to 528. Radiographs were obtained at baseline and at weeks 24, 52, 100, 148, 196, and 244. The primary measure of interest was radiographic nonprogression, defined as a change from baseline in mTSS of ≤0, reported as observed. A subgroup analysis examined whether patients free of radiographic progression at week 52 sustained that outcome through week 244.¹

Baseline characteristics reflected a csDMARD-inadequate-response population with meaningful disease burden: mean disease duration was 7.1 years, mean swollen joint count was 12.1, and mean baseline mTSS was 13.0.¹

Across the full 244-week observation period, mean change from baseline in mTSS remained minimal in the risankizumab arm, increasing from 0.03 at week 24 to 0.93 at week 244 — a modest absolute change over approximately five years of follow-up.¹ The proportion of patients with no radiographic progression (mTSS change ≤0) was 88.4% at week 244, remaining generally stable across all assessed timepoints.¹

The maintenance of nonprogression analysis examined patients who were already nonprogressors at week 52 — a prespecified subgroup intended to capture those who established early structural protection. Among this cohort, mean change from baseline in mTSS remained minimal through week 244 (0.25), and 93.4% remained nonprogressors at week 244.¹

The authors noted that safety was not assessed in this analysis but referenced the overall KEEPsAKE 1 safety record, which has shown risankizumab to be generally well-tolerated with no new signals through 244 weeks.¹

Limitations

The analysis carries a significant methodological caveat: as a post hoc analysis, it was not powered to detect statistically significant differences between progressors and nonprogressors in rates of structural damage or mTSS scores. Additionally, changes from baseline in mTSS were not statistically different between risankizumab and placebo at week 24, which was a ranked secondary endpoint in KEEPsAKE 1.¹ The nonprogression proportions reported here were a prespecified but nonranked endpoint, meaning no formal statistical conclusions can be drawn. Findings should be interpreted in that context.

Clinical Context

Structural joint damage in PsA is cumulative and, once established, irreversible. Joint erosion and joint space narrowing, both captured by mTSS, can impair physical function and contribute to long-term disability, underscoring the clinical importance of sustained radiographic protection beyond early trial endpoints.

The 5-year KEEPsAKE 1 data add to a growing body of long-term evidence for risankizumab in PsA. The combined 196-week analysis of KEEPsAKE 1 and KEEPsAKE 2, published in Rheumatology and Therapy in 2025, reported durable ACR20, minimal disease activity, and skin response through approximately 4 years of follow-up, with a consistent safety profile and no new signals across both csDMARD-IR and biologic-IR patient populations.² The 244-week radiographic data presented at AAD 2026 now extend that structural picture by an additional year.

The data are also contextually relevant given the current competitive landscape in PsA. Earlier this month, UCB announced that bimekizumab (Bimzelx) demonstrated superiority over risankizumab on ACR50 at week 16 in the head-to-head BE BOLD trial — the first superiority result by a licensed biologic over an IL-23 inhibitor in PsA.3 Long-term structural data from KEEPsAKE 1, while carrying the limitations noted above, represent an evidence base that head-to-head efficacy data at a single timepoint do not address.

References

1. Lonowski S, Khattri S, Talia J, et al. Long-term efficacy of risankizumab in maintenance of radiographic nonprogression in patients with active psoriatic arthritis: 5-year data from the KEEPsAKE 1 phase 3 trial. Poster presented at: 2026 American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO. Poster DV-018384.

2. Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 196-week results from the KEEPsAKE 1 and KEEPsAKE 2 randomized clinical trials. Rheumatol Ther. 2025;12(6):1103–1123. doi:10.1007/s40744-025-00793-3

3. Johnson V. Bimekizumab Beats Risankizumab on PsA ACR50 in Preliminary Head-to-Head Data. Article. RheumatologyLive. March 11, 2026. https://www.rheum-live.com/view/bimekizumab-beats-risankizumab-psa-acr50-preliminary-head-to-head-data