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Observational Study
. 2025 Nov;64(11):2038-2044.
doi: 10.1111/ijd.17927. Epub 2025 Jun 27.

Effectiveness of Bimekizumab in Psoriatic Arthritis: A Multicenter Real-Life Study With Clinical and Ultrasound Evaluation in the Lazio Region, Italy

Giacomo Caldarola  1   2 , Annunziata Dattola  3 , Nicoletta Bernardini  4 , Veronica Blundo  5 , Elena Campione  6   7 , Eleonora De Luca  1   2 , Domenico Giordano  3 , Alessandro Giunta  7 , Gaia Moretta  8 , Diego Orsini  9 , Gianluca Pagnanelli  8 , Antonio Richetta  3 , Andrea Picchianti Diamanti  5
Affiliations
Observational Study

Effectiveness of Bimekizumab in Psoriatic Arthritis: A Multicenter Real-Life Study With Clinical and Ultrasound Evaluation in the Lazio Region, Italy

Giacomo Caldarola et al. Int J Dermatol. 2025 Nov.

Abstract

Background: Bimekizumab, a monoclonal antibody targeting interleukin (IL)-17A and IL-17F, has shown efficacy in psoriatic arthritis (PsA) clinical trials, but real-world data on its effectiveness are limited. This study aimed to evaluate its real-world effectiveness in PsA patients treated in dermatologic settings.

Methods: We conducted a multicenter, prospective, observational study in dermatology units across Lazio, Italy, including 20 patients with psoriasis and PsA treated with bimekizumab. Rheumatologic assessments were performed at baseline and after 16 weeks, evaluating tender and swollen joint counts, the Visual Analog Scale (VAS) pain score, the Disease Activity in Psoriatic Arthritis (DAPSA) score, and the Leeds Enthesitis Index (LEI). Ultrasound evaluations (US) of joints and entheses were conducted at baseline and Week 16.

Results: Twenty patients were enrolled, including 10 bio-experienced patients. At 16 weeks, significant improvements were observed in tender joint count (3.65 to 2.15, p = 0.004), swollen joint count (1.35 to 0.55, p = 0.028), VAS pain score (6.35 to 3.35, p < 0.001), DAPSA (22.71 to 8.67, p < 0.001), and LEI (0.85 to 0.25, p = 0.004). US revealed a decrease in the number of patients with power Doppler (PD) positive joints (45% to 25%) and a reduction in synovial PD score (2.26 to 0.81, p = 0.002). The number of patients with US-positive enthesitis decreased (50% to 30%), with a significant reduction in the enthesis PD score (1.00 to 0.25, p = 0.047). Four patients (20%) developed mild candidiasis, with no treatment discontinuation.

Conclusions: Bimekizumab demonstrated significant, rapid improvements in real-world PsA patients, including those with prior biologic failures. Its favorable safety profile and effectiveness highlight its potential as a valuable treatment option for PsA.

Keywords: Interleukin‐17; bimekizumab; biologic therapies; psoriasis; psoriatic arthritis; real‐world effectiveness; ultrasound.

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Conflict of interest statement

Giacomo Caldarola has received consulting fees, honoraria, and support for attending meetings from AbbVie, Lilly, Janssen, UCB, Novartis, and Leopharma; Diego Orsini has been a speaker and/or consultant for AbbVie, Almirall, LeoPharma, UCB, Bristol‐MyersSquibb, and Boehringer Ingelheim. All other authors declare that they have no conflicts of interest relevant to this manuscript.

Figures

FIGURE 1
FIGURE 1
Active enthesitis of the Achilles' tendon with concomitant signs of retrocalcaneal bursitis (A) and complete resolution after 16 weeks of treatment with bimekizumab.
FIGURE 2
FIGURE 2
Patient at baseline (A), after 4 weeks (B), and 16 weeks (C) of treatment with bimekizumab.
FIGURE 3
FIGURE 3
(A) (T0): Synovitis of the third metacarpophalangeal (MCP) joint of the right hand, with grade 3 power Doppler (PD) signal and subcutaneous edema. (B) (T1): Resolution of synovitis with the absence of PD signal and a reduction in subcutaneous edema.
See this image and copyright information in PMC

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