Real-world Efficacy of Risankizumab in Psoriasis Shown for Patients With Prior Biologic Failure

Real-world patients with moderate to severe plaque psoriasis who had experienced prior biologic failure demonstrated significant improvement and an adequate safety profile with risankizumab, according to study findings published in Dermatologic Therapy.

With recent progress made in the understanding of psoriasis pathogenesis, particularly the interleukin (IL)-23/17 axis, several new treatment options have emerged.

Risankizumab, a humanized immunoglobulin G1 monoclonal antibody specifically targeting IL-23 by binding its p19 subunit, is one of the several FDA-approved biologic therapies that has shown efficacy for the treatment of moderate to severe psoriasis. Several factors have been shown to negatively impact therapy response.

“The need for a tailored treatment as well as the importance of comorbidities and possible biologic drug related events (eg, paradoxical psoriatic arthritis [PsA] or paradoxical eczematous eruptions) may still provide therapeutic challenges,” said the study authors. “This is particularly true in real life settings which deal with more complicated (numerous comorbidities, polypharmacy, and frequent previous failure of biologics) subjects compared with trials.”

Researchers conducted a monocentric retrospective study to investigate the efficacy and safety of risankizumab in a real-world setting. They additionally examined whether previous failure (primary or secondary failure) of one or more anti-IL17 drugs (brodalumab, ixekizumab, and/or secukinumab) would impair efficacy of risankizumab.

A total of 39 patients (mean [SD] age, 50.5 [13.7] years; 66.7% male) with moderate to severe psoriasis undergoing treatment with risankizumab and attending the Psoriasis Care Centre of Dermatology at the University Federico II of Naples, Italy, from May 2019 to January 2022, were enrolled in the 52-week retrospective analysis.

At baseline, participants provided information on demographics (age, sex) and clinical features, including psoriasis duration, duration of PsA (if present), psoriasis severity through Body Surface Area (BSA), Psoriasis Activity Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), comorbidities, and previous/current psoriasis treatment. Psoriasis severity (PASI, BSA, and NAPSI) was assessed at each follow-up visit (week 4, week 16, week 28, week 40, and week 52)

“Regarding the efficacy, primary lack of efficacy was considered as a clinical response less than a PASI 75 after 16 weeks of treatment whereas secondary inefficacy was defined as the assessment of an inadequate improvement less than PASI75 after an initial clinical response at 16 weeks,” said researchers. “Safety was assessed by treatment-emergent adverse events (AEs), physical examinations, and laboratory monitoring.”

Of the study cohort, 15 patients (38.5%) were affected by PsA and 9 patients (23.1%) had nail involvement, with a mean [SD] PASI of 13.7 [5.8], mean [SD] BSA of 21.9 [14.6], and a mean [SD] NAPSI of 9.3 [4.7] identified. All of the patients experienced a treatment failure with at least one anti-IL17 drug, particularly 26 (66.7%) failed ixekizumab, 24 (61.5%) secukinumab, 7 (17.9%) both secukinumab and ixekizumab, and 2 (5.1%) brodalumab.

Findings demonstrated a statistically significant reduction of PASI and BSA at each follow-up visit for patients treated with risankizumab, as well as significant improvement in nail involvement after week 16:

• Mean [SD] PASI at baseline vs week 52, 13.7 [5.8] vs 0.9 [0.8]; P < .0001
• Mean [SD] BSA at baseline vs week 52, 21.9 [14.6] vs 1.9 [1.7]; P < .0001
• Mean [SD] NAPSI at baseline (9.3 [4.7]), at week 16 (4.1 [2.4]), and week 52 (1.4 [0.8]) (P < .0001)
  

No cases of serious adverse events were assessed, with treatment discontinued for primary and secondary inefficacy in 1 (2.6%) and 3 (7.7%) patients, respectively. Researchers concluded that further studies are needed to confirm their results, as well as to gain data to support the best evidence-based biologic selection algorithm.

Reference

Megna M, Potestio L, Ruggiero A, Camela E, Fabbrocini G. Risankizumab treatment in psoriasis patients who failed anti-IL17: a 52-week real-life study. Dermatol Ther. 2022 Apr 19;e15524. doi:10.1111/dth.15524