Bruce Strober, MD, PhD

Credit: Yale School of Medicine

Risankizumab shows durable efficacy in the long-term for patients with psoriasis and consistent efficacy through 256 weeks over different subgroups, according to recent findings.¹

These findings were the results of the LIMMitless open-label extension study, during which investigators looked into the use of risankizumab in psoriasis patients over the course of 256 weeks. This research was led by Bruce Strober, MD, PhD, from Yale University’s department of dermatology.

Strober and colleagues noted that risankizumab’s long-term effectiveness, based upon baseline patient characteristics, had previously not been reported past 52 weeks. A previous subgroup analysis of patients from the phase 3 UltIMMa-1/2 studies did suggest that risankizumab 150-mg led to similar rates of efficacy across a range of various baseline characteristics at 16 and 52 weeks, however.²

“Herein we report interim results from the LIMMitless open-label extension (OLE) study…evaluating the efficacy of risankizumab according to baseline patient characteristics as well as efficacy for nail, scalp and palmoplantar psoriasis, through nearly 5 years of continuous treatment,” Strober and colleagues wrote.

Background and Findings

The investigators focused on patients who had been randomized to risankizumab 150 mg at baseline within 2 identical phase 3 trials, UltIMMa-1/2, and the subsequent long-term LIMMitless open-label extension study.

While criteria and design had been reported previously, the investigators noted that adult participants with moderate-to-severe plaque psoriasis were treated at the 0, 4, 16, 28, and 40-week marks during the UltIMMa-1/2 studies, and they were blinded from baseline to 52 weeks.

After UltIMMa-1/2, the subjects involved were continually involved in the LIMMitless trial at week 52 and then every 12 weeks following this point. The investigators looked at psoriatic disease manifestations, including scalp, nail, and/or palmoplantar psoriasis at the point of UltIMMa-1/2 baseline, using subsets of these individuals.

The subsets of the participants were defined by Psoriasis Scalp Severity Index (PSSI) >0, Nail Psoriasis Severity Index (NAPSI) >0, and/or Palmoplantar Psoriasis Area and Severity Index (PPASI) >0, respectively. The research team looked at a time frame of 256 weeks of continuous treatment.

The team also looked at the efficacy of the drug by considering demographics at the point of baseline, such as sex, age, body mass index (BMI), and weight. They also considered psoriatic disease qualities such as psoriatic arthritis (PsA) status and the subjects’ baseline PASI scores.

The assessment of specific psoriatic disease manifestations involved the use of Nail Psoriasis Severity Index (NAPSI) for nail psoriasis, Psoriasis Scalp Severity Index (PSSI) for scalp psoriasis, and Palmoplantar Psoriasis Area and Severity Index (PPASI) for palmoplantar psoriasis. The investigators’ research included evaluations of participants’ mean percentage improvement from the point of baseline in NAPSI, PSSI, and/or PPASI, respectively.

The team looked at participants who were able to reach a point of total resolution (NAPSI = 0, PSSI = 0, and/or PPASI = 0).

Overall, the investigators found there was a comparable percentage of study participants achieving PASI 90/100 by the 256-week mark, and this had been shown to be irrespective of subjects’ gender, BMI, initial age, weight, PASI, or psoriatic arthritis condition.

Those with scalp, nail, and/or palmoplantar psoriasis were shown by the research team to have major enhancements in the manifestation-specific indices assessed in the research. Specifically, the team showed there was an average improvement exceeding 94%, 81%, and 97%, respectively, from the point of baseline to 256 weeks.

Among participants shown to have all 3 manifestations (N = 121), the investigators reported that 44.6% were able to reach a complete resolution of their noted manifestations by the 256-week mark.

“These findings demonstrate the ability of risankizumab to comprehensively address psoriatic symptoms, including difficult-to-treat manifestations in specialized areas, and highlight the versatility of risankizumab treatment across a wide range of patient phenotypes,” they wrote.

References

1. ^{Strober B, Bachelez H, Crowley J, Elewski BE, Gooderham M, Menter A, et al. Efficacy of long-term risankizumab treatment for moderate-to-severe plaque psoriasis: Subgroup analyses by baseline characteristics and psoriatic disease manifestations through 256 weeks (LIMMitless trial). J Eur Acad Dermatol Venereol. 2024; 00: 1–9. https://doi.org/10.1111/jdv.19748.}
2. ^{Strober B, Menter A, Leonardi C, Gordon K, Lambert J, Puig L, et al. Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa-1 and UltIMMa-2 studies. J Eur Acad Dermatol Venereol. 2020; 34: 2830–2838.}