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Real-World Data Support Efficacy of IL-23 Inhibitors for Psoriatic Arthritis, Psoriasis

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Most patients were able to achieve clear or almost clear skin, and improvement of arthritis and difficult-to-treat areas, with guselkumab and risankizumab treatment.

New real-world data confirm the high efficacy and safety of IL23 inhibitors, including guselkumab and risankizumab, for the treatment of patients with psoriatic arthritis (PsA) and psoriasis reported in clinical trials.1

Conducted at a multidisciplinary dermatology-rheumatology outpatient clinic, the analysis confirms both guselkumab and risankizumab achieved an optimal response for both skin and articular manifestations, but more research is needed to confirm their role in axial involvement.

“The majority of patients achieved clear or almost clear skin, and improvement of arthritis and difficult-to-treat areas, starting from week 4, with a maximal effect at week 24,” wrote the investigative team, led by Aristeidis G. Vaiopoulos MD, PhD, second department of dermatology and venereology, Attikon University General Hospital.

Chronic inflammatory skin and joint disorders, such as PsA and psoriasis, are associated with various comorbidities and can have serious implications for patient quality of life. Developments in the field of biologic treatments have led to the development of IL23 inhibitors, including guselkumab and risankizumab. The US Food and Drug Administration (FDA) approved guselkumab as the first IL23 inhibitor for psoriasis in 2017 and PsA in 2020,2 while risankizumab was approved in 2019 and 2022, respectively.3

Clinical trial data have proven the efficacy of IL23 inhibitors in psoriasis, PsA, and difficult-to-treat areas. However, real-world practice may differ from clinical trials, due to the exclusion of specific patient categories, and these data are limited, particularly for patients with PsA. Vaiopoulos and colleagues conducted a single-center retrospective study from September 2021 to June 2022, enrolling patients with PsA and moderate-to-severe plaque psoriasis at their institution’s multidisciplinary psoriasis outpatient clinic.1

Treatment with guselkumab was administered as 100 mg at week 0, 4, and then every 8 weeks, while treatment with risankizumab was administered as 150 mg at week 0, 4, and then every 12 weeks subcutaneously. The study’s primary endpoint was the evaluation of Absolute Psoriasis Area and Severity Index (aPASI) and Disease Activity Index for PsA (DAPSA) at week 24. Secondary endpoints included the percentage of patients achieving a ΔPASI reduction of 75/90/100% at Weeks 2, 16, and 24.

The study included 59 patients, including 55.9% male patients, with a mean age of 51.7%. Of this population, 24 patients (40.7%) had a diagnosis of PsA, and 4 suffered from axial involvement. Guselkumab was administered in 37 patients (62.7%) and risankizumab was administered in 22 patients (37.3%).

Treatment groups were comparable in age, gender, psoriasis and PsA disease severity, comorbidities, and previous systemic treatments (P >.05). Approximately half of the patients had obesity (49.2%), with a mean body mass index of 31.3 kg/m2. Most patients were pretreated, with only 8 patients (13.6%) naive to previous systemic treatments, while 40 patients (67.8%) were bio-experienced.

All patients reached the 24-week observation endpoint, without major safety signals responsible for medication discontinuation. Upon analysis, investigators found all indices of clinical response (ΔPASI 75/90/100) were significantly improved, while all scores (aPASI, DAPSA) were reduced up to week 24.

At week 24, data showed 91.4%, 84.5%, and 72.4% of patients reached ΔPASI 75/90/100, respectively, while aPASI <3 was observed in 96.6% of patients. The treatment response in aPASI was independent of other factors, including gender, onset, comorbidities, disease duration, and current treatment (P >.05).

The analysis noted comorbidities and obesity did not affect skin response with IL23 treatment. Outcomes were affected by previous treatment status, with bio-naive patients exhibiting higher baseline aPASI compared to bio-experienced patients (13.08 vs. 9.64; P <.05). At week 24, aPASI was found to be significantly difference (P <.05) between bio-naive and bio-experienced patients.

Regarding difficult-to-treat areas, the analysis revealed that IL23 blockers were efficacious for patients with PsA and psoriasis. The mean scalp Physician's Global Assessment (PGA) score improved from baseline, with improvement at week 4, and a maximal treatment effect at week 24. Both palmoplantar manifestations (ppPGA) and nail involvement (nPGA) also showed significant improvement. Axial involvement was observed in 4 patients treated with guselkumab

In their conclusion, the investigative team identified no statistically significant difference in clinical efficacy between treatment with guselkumab or risankizumab (P >.05).

“According to our results, guselkumab and risankizumab were equally efficient in skin and joint manifestations, in agreement to other recent studies, with a better but not statistically significant skin response in patients receiving risankizumab,” investigators wrote.

References

  1. Vaiopoulos AG, Dalamaga M, Katsimbri P, et al. Real-world data show high efficacy of IL23 inhibitors guselkumab and risankizumab in psoriatic arthritis and difficult-to-treat areas [published online ahead of print, 2023 Sep 25]. Int J Dermatol. 2023;10.1111/ijd.16849. doi:10.1111/ijd.16849
  2. Walter K. FDA approves guselkumab for active psoriatic arthritis. HCP Live. February 4, 2021. Accessed September 27, 2023. https://www.hcplive.com/view/fda-guselkumab-active-psoriatic-arthritis.
  3. Kunzmann K. FDA approves risankizumab for active psoriatic arthritis. HCP Live. January 17, 2023. Accessed September 27, 2023. https://www.hcplive.com/view/fda-approves-risankizumab-for-active-psoriatic-arthritis.

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