Tildrakizumab Sustains Nail Psoriasis Efficacy Through 52 Weeks in Phase 3b Extension Data

New 52-week data from a phase 3b trial of tildrakizumab (Sun Pharma, ILUMYA) in moderate-to-severe nail psoriasis, presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting held in Denver, Colorado, from March 27-31, show continued improvement in nail clearance and sustained response among early responders — extending results first reported at last year’s meeting.¹

The study (NCT03897075) is the first dedicated phase 3b trial of an IL-23 inhibitor in nail psoriasis, a manifestation affecting roughly 40–50% of patients with plaque psoriasis that remains among the most difficult-to-treat domains of the disease due to the slow growth rate of the nail plate and limited long-term clinical trial data.²

Study Design and Week-28 Results

The multicenter, randomized, double-blind, placebo-controlled study enrolled 99 adults with moderate-to-severe plaque psoriasis and concurrent nail involvement, defined by a modified Nail Psoriasis Severity Index (mNAPSI) score of ≥20 and a ViSENPsO score of ≥3. Patients received tildrakizumab 100 mg or placebo; those originally randomized to placebo crossed over to tildrakizumab at week 28.¹

The primary endpoint of mNAPSI 75 response at week 28 was met, with 25.5% of tildrakizumab-treated patients achieving ≥75% improvement from baseline versus 4.5% in the placebo arm (P = .003). Additionally, 29.4% of tildrakizumab-treated patients achieved a ViSENPsO score of 0 (normal) or 1 (minimal) with a ≥2-point decrease from baseline, compared to 4.2% with placebo (P = .0008).¹

Week-52 Extension Results

Among 72 patients who completed the study through week 52, of which 40 were originally randomized to tildrakizumab and 32 originally to placebo, response rates in the continuous tildrakizumab arm continued to increase beyond week 28. The mNAPSI 75 response rate rose from 25.5% at week 28 to 41.2% at week 52, and 76.9% of week-28 mNAPSI 75 responders maintained that response at week 52.¹

A similar trajectory was observed for the ViSENPsO endpoint. The proportion achieving normal or near-normal nails increased from 29.4% at week 28 to 43.1% at week 52, with 60.0% of week-28 ViSENPsO responders sustaining that response at week 52.¹

The continued gains between weeks 28 and 52 are consistent with the biology of nail psoriasis treatment: fingernails take approximately 6 months to fully regenerate, meaning the full benefit of anti-inflammatory therapy on nail architecture emerges gradually and is often not captured at earlier timepoints.²

Investigator Paul Yamauchi, MD, PhD, President and Director of Dermatology, Dermatology Institute and Skin Care Center, and colleagues saw that safety through week 52 was consistent with tildrakizumab's established profile. Serious adverse events (AEs) occurred in 3 patients (5.9%) originally randomized to tildrakizumab. AEs of special interest were reported in 2 patients (3.9%) — 1 injection-related reaction and one case of pruritus. Missing data were imputed as nonresponse throughout.¹

About Tildrakizumab

Tildrakizumab selectively binds the p19 subunit of IL-23, suppressing downstream signaling through the Th17 axis that drives both cutaneous and nail manifestations of psoriasis. The drug is approved in the United States, Australia, Japan, and Europe (as ILUMETRI, marketed by Almirall) for moderate-to-severe plaque psoriasis. Sun Pharma also recently received Food and Drug Administration (FDA) acceptance of an sBLA for tildrakizumab in active PsA, with a PDUFA date of October 29, 2026, based on positive topline results from the INSPIRE-1 and INSPIRE-2 phase 3 trials.

Data from the AAD 2026 presentation represent the complete 52-week dataset for this nail psoriasis study. Full publication in a peer-reviewed journal is anticipated.

References

1. Yamauchi P, et al. Efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis affecting the nails: a multicenter, randomized, double-blind, placebo-controlled phase 3b trial. Presented at: 2026 AAD Annual Meeting; March 27–31, 2026; Denver, CO. Poster #72762

2. Renert-Yuval Y, Guttman-Yassky E, et al. Nail psoriasis: an updated review of currently available systemic treatments. J Drugs Dermatol. 2023. doi:10.2147/CCID.S417679