Long-term risankizumab safe, effective in moderate-to-severe plaque psoriasis

Treatment with risankizumab in the long term shows lasting efficacy against moderate-to-severe plaque psoriasis and has good tolerability, according to the LIMMitless study.

“[The results of interim analysis] demonstrate a consistent long-term safety profile and high and durable clinical response with continuous risankizumab treatment for up to 5 years,” the researchers said. “In addition, the benefits of continuous risankizumab treatment may have long-term positive effects on overall health-related quality of life in patients with psoriasis.”

LIMMitless is an ongoing phase III, open-label extension study examining the long-term safety and efficacy of continuous risankizumab 150 mg every 12 weeks for adult patients with moderate-to-severe plaque psoriasis following phase II/III base studies. In this interim analysis, the researchers evaluated safety by monitoring treatment-emergent adverse events (TEAEs) through 304 weeks.

Efficacy was also examined by determining the proportion of patients achieving ≥90 percent or 100 percent improvement in Psoriasis Area and Severity Index (PASI 90/100), static Physician’s Global Assessment of clear/almost clear (sPGA 0/1), and Dermatology Life Quality Index of no effect on patient’s life (DLQI 0/1) through 256 weeks.

A total of 897 patients were randomly assigned to receive risankizumab in the base studies, of whom 706 were still ongoing at data cutoff. There were low rates of TEAEs (155.3 events/100 person-years [PY]), serious AEs (6.9 events/100 PY), and TEAEs leading to discontinuation (1.7 events/100 PY) seen at week 304. [J Am Acad Dermatol 2023;89:1149-1158]

Nasopharyngitis (13.7 events/100 PY) was the most frequently reported TEAE, followed by upper respiratory tract infection (8.0 events/100 PY) and arthralgia (4.3 events/100 PY). The most common serious AE was osteoarthritis (0.2 event/100 PY). Among TEAEs leading to drug discontinuation, 29.2 percent were potentially related to risankizumab.

Among the patients included in the interim analysis, 85.1 percent achieved PASI 90 and 52.3 percent attained PASI 100, 85.8 percent achieved sPGA 0/1, and 76.4 percent attained DLQI 0/1.

“In this study, the rates of sustained response observed with risankizumab were comparable or greater than those observed for other interleukin (IL)-23 inhibitors for the treatment of plaque psoriasis after 4 to 5 years of continuous therapy,” the researchers said.

In the phase III reSURFACE 1 and 2 studies assessing tildrakizumab, 65.9 percent to 69.5 percent of patients achieved PASI 90 at week 244. In the phase III VOYAGE 1 and 2 studies of guselkumab, 82.0 percent to 84.1 percent of patients attained PASI 90 after 252 weeks. [Br J Dermatol 2021;185:323-334; Br J Dermatol 2021;185:1146-1159]

Additionally, 50.0 percent to 55.0 percent of patients in the phase III PHOENIX 2 study evaluating ustekinumab achieved PASI 90 after 244 weeks. [Br J Dermatol 2015;172:1371-1383]

“The LIMMitless study is still ongoing; however, the findings from this interim analysis highlight that the long-term use of risankizumab is a viable option for the safe and effective management of moderate-to-severe plaque psoriasis,” the researchers said.

The current study was limited by its open-label design with no placebo or active-comparator group.