Abstract
Background
Bimekizumab, a dual IL-17A and IL-17F inhibitor, has demonstrated high efficacy in moderate- to-severe psoriasis in clinical trials. However, real-world evidence in patients with moderate disease remains limited.
Methods
This retrospective multicentre study evaluated the effectiveness and safety of bimekizumab over 54 weeks in adults with moderate plaque psoriasis treated across five dermatology centres in the Lazio region (Italy).
Results
Fifty-nine patients initiated treatment, and 50 completed follow-up; PASI data at week 54 were available for 19 patients, whilst nail data at week 54 were available for 23 patients. Mean Psoriasis Area and Severity Index (PASI) decreased from 9.20 at baseline to 1.31 at week 4, 0.31 at week 16, 0.09 at week 24 and 0.05 at week 54. Nail involvement improved progressively, with mean Nail Psoriasis Severity Index declining from 2.96 at baseline to 0.03 at week 24, with complete clearance observed in all evaluable patients at week 54. More than 60% of patients achieved PASI90 by week 4, almost 90% reached PASI90 and approximately 88% achieved PASI100 by week 16, whilst nearly all patients attained complete clearance (PASI100) by week 54. Responses were comparable between biologic-naive and biologic-experienced patients. Adverse events occurred in 8 patients (13.6%), predominantly mild oral candidiasis, with no serious adverse events or treatment discontinuations.
Conclusion
These findings suggest that bimekizumab provides rapid and sustained skin clearance with favourable tolerability in patients with moderate psoriasis, supporting the consideration of early systemic treatment as a potential strategy to reduce disease burden in this population.
Keywords: bimekizumab, IL-17 inhibitors, moderate psoriasis, real-world evidence
PLAIN LANGUAGE SUMMARY
Psoriasis is a chronic inflammatory skin disease that can significantly affect patients’ quality of life, even when the degree of psoriasis is classified as ‘moderate’. Many patients experience persistent symptoms, visible lesions, nail involvement or disease in sensitive body areas that can impair daily activities and emotional well-being. Despite this, moderate psoriasis is often undertreated in routine clinical practice.
Bimekizumab is a biologic therapy that blocks two in flammatory proteins involved in psoriasis, IL-17A and IL-17F. Clinical trials have shown high levels of skin clearance in patients with moderate-to-severe psoriasis but real-world evidence in patients with moderate disease remains limited.
This multicenter Italian study evaluated the effectiveness and safety of bimekizumab in adults with moderate plaque psoriasis treated in routine clinical practice across five dermatology centers in the Lazio region. Fifty-nine patients started treatment, and 50 completed the 54-week follow-up period. Researchers assessed improvements in skin lesions using the Psoriasis Area and Severity Index (PASI), nail involvement using the Nail Psoriasis Severity Index (NAPSI), and assessed the effect in difficult-to-treat areas as well as treatment safety.
The study demonstrated rapid and sustained clinical improvement. Mean PASI scores decreased substantially as early as week 4 and continued to improve through week 54. More than 60% of patients achieved PASI90 by week 4, while almost 90% achieved PASI90 and approximately 88% achieved complete skin clearance (PASI100) by week 16. Nearly all evaluable patients achieved PASI100 at week 54.
Bimekizumab also showed high effectiveness in difficult-to- treat areas such as the scalp, genital region, trunk and limbs. Nail psoriasis progressively improved during follow-up, with complete nail clearance observed in all evaluable patients at week 54. Patients with psoriatic arthritis also experienced reductions in joint pain and inflammatory markers over time.
Treatment was generally well tolerated. Adverse events were mostly mild, with oral candidiasis representing the most common side effect. No serious adverse events or treatment discontinuations related to safety were reported.
Overall, these findings suggest that bimekizumab provides rapid, profound and durable disease control in patients with moderate plaque psoriasis under real-world conditions. The study also highlights the importance of recognizing moderate psoriasis as a potentially burdensome systemic inflammatory disease that may benefit from early and effective biologic treatment.
Introduction
Psoriasis is a chronic, immune-mediated, polygenic systemic disease with predominant cutaneous expression, characterized by erythematous, scaly plaques and a relapsing–remitting course. Once regarded as a disorder limited to hyperproliferation of keratinocytes, psoriasis is now recognized as a systemic inflammatory disease driven by complex interactions between genetic predisposition, immune dysregulation and environmental triggers such as infections, stress and drugs. Histologically, psoriatic lesions show acanthosis, parakeratosis and dilated dermal capillaries with an infiltrate of activated T cells and dendritic cells, hallmarks of chronic immune activation.1
Globally, psoriasis affects 0.2–4.6% of the population, with higher prevalence in Western countries; in Italy, it affects approximately 2.5% of adults. Beyond the visible skin involvement, psoriasis exerts profound systemic, physical and psychological effects. Patients frequently have pruritus, pain and stigmatization, along with an increased risk of metabolic syndrome, cardiovascular disease, depression and psoriatic arthritis (PsA). This convergence of inflammation and psychosocial burden contributes to the so-called ‘cumulative life course impairment’, which represents a progressive and measurable loss in quality of life (QoL). Notably, patients with moderate psoriasis often report impairment comparable to those with severe disease, particularly when lesions affect visible or sensitive sites such as the scalp, nails or genitals. Modern management strategies therefore emphasize early and comprehensive control of inflammation to reduce disease burden and potentially limit long-term disease-related complications.
From a pathophysiological perspective, psoriasis arises from a dysregulated cytokine network centred on the TH1, TH17 and TH22 pathways. Activated dendritic cells secrete IL-12 and IL-23, driving differentiation of TH1 and TH17 cells. TH1 lymphocytes release IFNγ and IL-2, amplifying the inflammatory response, whilst TH17 cells produce IL-17A and IL-17F, which stimulates keratinocytes to proliferate and to secrete IL-1β, IL-6 and antimicrobial peptides, thereby perpetuating inflammation.2 Amongst these mediators, the IL-17 family represents one of the central effectors of psoriatic inflammation, directly linking immune activation to keratinocyte dysfunction and neutrophilic infiltration. Persistent IL-17-driven signalling is also implicated in the development of arthritis, metabolic alterations and vascular inflammation, confirming the systemic nature of the disease.
Therapeutic advances have progressively targeted these key pathways. Whilst conventional systemic agents, such as methotrexate, cyclosporine and acitretin, remain useful, their long-term use is limited by toxicity and waning efficacy. The advent of biologic therapies has revolutionized psoriasis management, allowing selective and sustained immunomodulation.3,4 Agents blocking TNF, IL-12/IL-23 or IL-17A provide robust clinical responses, yet incomplete suppression of IL-17F may leave residual inflammatory activity. Both IL-17A and IL-17F act through the same receptor complex and function synergistically to promote keratinocyte activation; therefore, dual inhibition offers broader and deeper blockade of the psoriatic inflammatory cascade.5
Bimekizumab, a humanized IgG1 monoclonal antibody that neutralizes both IL-17A and IL-17F, represents the latest evolution of IL-17-targeted therapy. By simultaneously suppressing overlapping cytokine signals, it effectively interrupts the feedback loop sustaining chronic inflammation and epidermal proliferation. Phase III trials (BE READY, BE SURE, BE VIVID, BE RADIANT) have shown that bimekizumab induces rapid and durable clearance, with the majority of patients achieving complete (Psoriasis Area and Severity Index (PASI 100)) response by week 16.6–8 Its efficacy extends to traditionally refractory sites, such as the scalp, nails and genital areas, with an overall favourable safety profile characterized primarily by mild oral candidiasis.9–11
Despite these encouraging results, real-world evidence in patients with moderate psoriasis remains limited. This population often occupies a therapeutic ‘grey zone’ as their PASI scores may underestimate the true disease burden, leading to under-treatment despite significant systemic inflammation and QoL impact. Recognizing that moderate psoriasis shares the same immunopathogenic mechanisms as severe disease highlights the rationale for early biologic therapy.
The present multicentre Italian study was therefore designed to evaluate the long-term effectiveness and safety of bimekizumab in adults with moderate plaque psoriasis. By focusing on this frequently overlooked cohort, we aimed to bridge the gap between pivotal clinical trials and routine clinical practice, emphasizing the potential of early IL-17A/F dual blockade to achieve sustained remission and improve patients’ QoL.
Methods
We conducted a retrospective, multicentre, real-life observational study across five dermatology units in the Lazio region of Italy: Policlinico Umberto I (Sapienza University of Rome), Istituto Dermopatico dell’Immacolata (IDI-IRCCS), Sant’ Andrea Hospital, Fondazione Policlinico Universitario A. Gemelli IRCCS and Ospedale Alfredo Fiorini (Terracina). The study included adult patients (≥18 years) with a diagnosis of moderate plaque psoriasis who initiated bimekizumab treatment between 2022 and 2024.
Eligible patients were adults with moderate plaque psoriasis treated with bimekizumab in routine clinical practice. Patients with incomplete baseline data or without at least one post-baseline clinical assessment were excluded from the effectiveness analysis. Concomitant topical treatments were allowed, whereas no concomitant systemic psoriasis therapies were administered during follow-up. Moderate psoriasis was defined as a baseline PASI score between 8 and 10, or PASI <8 accompanied by a Dermatology Life Quality Index (DLQI) score ≥5. Because a universally accepted definition of moderate psoriasis is lacking, this pragmatic definition was adopted to capture patients with clinically relevant disease burden despite relatively low PASI values, particularly in cases involving visible or sensitive anatomical sites. Patients with concomitant PsA, confirmed by a rheumatologist according to CASPAR classification criteria, were included in a predefined subgroup analysis.
The study was conducted in accordance with the Declaration of Helsinki and approved by the local ethics committee. Written informed consent was obtained from all participants prior to study enrolment. No identifiable individual data are included.
End points
The primary end point was the evolution of PASI over time and the proportion of patients achieving PASI90 and PASI100 responses at week 54.
Secondary end points included improvement in nail psoriasis measured using the Nail Psoriasis Severity Index (NAPSI), clearance of difficult-to-treat areas (scalp, genital, palmoplantar and trunk), treatment persistence and safety outcomes.
In the PsA subgroup, musculoskeletal outcomes were evaluated through pain intensity using a visual analogue scale (VAS) and inflammatory markers, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
Bimekizumab was administered subcutaneously according to the EMA-approved dosing regimen: 320 mg at weeks 0, 4, 8, 12 and 16, followed by 320 mg every 8 weeks as maintenance therapy. Occasional topical treatments were permitted when required.
Baseline demographic and clinical data included age, sex, body mass index (BMI), disease duration and prior systemic or biologic treatments. Patients were stratified into biologic-naive and biologic-experienced subgroups.
Safety assessment
Safety data were collected retrospectively from medical records at scheduled visits and from any unscheduled contacts. Adverse events (AEs) were recorded as documented by treating physicians and classified according to clinical severity. Oral candidiasis was identified based on clinical diagnosis and managed according to routine clinical practice.
Statistical analysis
Statistical analyses were primarily descriptive. Additionally, inferential statistics were performed to support within-patient changes over time.
Continuous outcomes were analysed using linear mixed-effects models to allow the inclusion of all available observations without requiring complete follow-up for each patient. This approach accounts for the correlation between repeated measures and provides valid estimates under the assumption that data are missing at random. Therefore, patients with partially missing data at certain time points were retained in the analysis, and all available measurements contributed to the model estimation. Multiple comparisons were adjusted using the Holm method. Loss to follow-up could not be explicitly distinguished from intermittent missing data due to the dataset structure. However, the use of mixed-effects models mitigates this limitation by incorporating all available data points and avoiding the exclusion of patients with incomplete observations. Categorical response rates (PASI90, PASI100 and NAPSI0) are presented with 95% confidence intervals calculated using the Clopper–Pearson method.
The analytical approach used reduces bias compared to complete-case analysis and maximizes statistical power by leveraging all observed data. No imputation of missing values was performed. Statistical significance was set at p<0.05 (two-sided). Analyses were performed using R software (version 4.5.3; R Foundation for Statistical Computing, Vienna and Austria).
Results
A total of 59 patients initiated treatment with bimekizumab. Fifty patients remained in follow-up through week 54; however, due to missed visits and the retrospective nature of data collection, PASI data at week 54 were available for only 19 patients and nail (NAPSI) data at week 54 were available for 23 patients. Effectiveness analyses were therefore based on available data at each time point, and corresponding sample sizes are reported throughout. A patient disposition flowchart illustrating the number of evaluable patients at each time point, including missed visits and losses to follow-up, is provided in Figure 1. Nine patients discontinued treatment prematurely due to loss to follow-up or personal reasons unrelated to AEs.
Figure 1.
Patient disposition flowchart. Of 59 patients who initiated bimekizumab, 9 discontinued prematurely (loss to follow-up or personal reasons unrelated to adverse events; timing unspecified due to the retrospective study design), leaving 50 patients under clinical follow-up through week 54. Due to missed visits and incomplete data collection, PASI assessments at week 54 were available for 19 patients and NAPSI assessments for 23 patients.
Baseline characteristics reflected a real-world population with long-standing disease burden. Baseline demographic and clinical characteristics of enrolled patients are summarized in Table 1. The mean age of the analysed cohort was 50 years (range 20–74), with women accounting for 56%. The mean BMI was 25.6 kg/m2, and the mean disease duration was 18.3 years, indicating a long-standing inflammatory burden. PsA was present in 22% of patients (13/59). At baseline, cutaneous involvement predominantly affected the upper limbs (80%), trunk (73%), lower limbs (66%), and head/neck (61%), whilst palmoplantar disease was reported in 8.5% of individuals (Figure 2).
Table 1.
Baseline demographic and clinical characteristics of patients.
| Characteristic | Overall cohort (n=59) |
|---|---|
| Demographic characteristics | |
| Age, years | 49.8±12.4 |
| Sex, female | 33 (55.9%) |
| Weight, kg | 72.9±13.2 |
| BMI, kg/m2 | 25.6±3.8 |
| Disease-related characteristics | |
| Disease duration, years | 18.3±15.9 |
| Psoriatic arthritis | 13 (22.0%) |
| Biologic-naive patients | 24 (40.7%) |
| Biologic-experienced patients | 35 (59.3%) |
| Body site involvement | |
| Head/neck | 36 (61.0%) |
| Upper limbs | 47 (79.7%) |
| Trunk | 43 (72.9%) |
| Lower limbs | 39 (66.1%) |
| Palmoplantar involvement | 5 (8.5%) |
| Previous biologic treatments (biologic-experienced patients) | |
| Adalimumab | 18 (51.4%) |
| Brodalumab | 4 (11.4%) |
| Ixekizumab | 2 (5.7%) |
| Tildrakizumab | 2 (5.7%) |
| Other biologicsa | 9 (25.7%) |
Values are reported as mean±standard deviation or n (%). Percentages for previous biologic treatments are calculated within the biologic-experienced subgroup.
Includes etanercept, guselkumab, risankizumab, secukinumab, ustekinumab and combination/sequential therapies.
Figure 2.
UpSet plot. UpSet plot illustrating the overlap amongst head/neck, upper limbs, trunk and lower limbs involvement. The left panel shows the number of patients affected at each anatomical site, whilst the upper bars represent the frequency of each anatomical-site combination. Only patients with complete body-site documentation were included in the analysis (49 of 59); the remaining 10 patients had incomplete site-level records due to the retrospective data collection.
Bimekizumab induced a rapid and sustained reduction in psoriasis severity. PASI evolution over time is summarized in Table 2; PASI data at week 54 were available for 19 patients. Mean PASI decreased from 9.20±3.92 at baseline to 1.31 at week 4, 0.31 at week 16, 0.09 at week 24 and 0.05 at week 54, demonstrating a clinically meaningful improvement over time. All post-baseline time points showed a statistically significant reduction compared with baseline (all Holm-adjusted p<0.001), with the greatest improvement observed by week 24. More than 60% of patients achieved PASI90 as early as week 4, almost 90% reached PASI90, and approximately 88% achieved PASI100 by week 16, whilst nearly all patients attained complete clearance (PASI100) by week 54 (Figure 3).
Table 2.
PASI response over time.
| Time point | Patients evaluated (n) | Mean PASI±SD |
|---|---|---|
| Baseline | 59 | 9.20±3.92 |
| Week 4 | 58 | 1.31±1.92 |
| Week 16 | 58 | 0.31±0.90 |
| Week 24 | 58 | 0.09±0.39 |
| Week 54 | 19 | 0.05±0.23 |
Values are reported as mean±standard deviation (SD). The number of evaluable patients varied across time points because of missed visits, incomplete follow-up assessments and intermittent missing data inherent to the retrospective multicentre real-world study design.
Figure 3.
PASI response over time. Mean Psoriasis Area and Severity Index (PASI) values at baseline, week 4, week 16, week 24 and week 54. Error bars represent 95% confidence intervals (CI). The number of evaluable patients at each time point is reported above each marker (baseline: n=59; weeks 4–24: n=58; week 54: n=19). The reduced number of evaluable patients at week 54 reflects incomplete follow-up assessments and intermittent missing data inherent to the retrospective real-world study design; of the 50 patients who remained under clinical follow-up through week 54, PASI data were available for 19. For full patient disposition details, see Figure 1.
Bio-naive versus bio-experienced patients
Biologic-naive patients (n=24) demonstrated a slightly faster response, achieving a mean PASI of 0.22 at week 16 compared with 0.37 in biologic-experienced individuals (n=35). However, by week 54, both subgroups reached near-complete skin clearance, suggesting that prior biologic exposure did not meaningfully attenuate treatment effectiveness. PASI responses stratified by previous biologic exposure are summarized in Table 3. Within-group analyses showed significant reductions from baseline at all time points in both groups (all Holm-adjusted p<0.001), with a comparable magnitude of improvement between groups.
Table 3.
PASI response according to biologic exposure.
| Time point | Biologic-experienced, mean PASI±SD (n) | Biologic-naive, mean PASI±SD (n) |
|---|---|---|
| Baseline | 9.17±4.13 (35) | 9.25±3.67 (24) |
| Week 4 | 1.23±1.96 (35) | 1.44±1.90 (23) |
| Week 16 | 0.37±1.06 (35) | 0.22±0.60 (23) |
| Week 24 | 0.14±0.49 (35) | 0.00±0.00 (23) |
| Week 54 | 0.08±0.29 (12) | 0.00±0.00 (7) |
Values are reported as mean±standard deviation (SD). The number of evaluable patients differs across time points due to missing follow-up data.
Involvement of difficult-to-treat areas
Marked improvement was also observed in sensitive and difficult-to-treat areas. Amongst patients with baseline involvement, genital PASI decreased from 2.36 to 0.00, scalp PASI from 3.12 to 0.03, upper limb PASI from 3.41 to 0.07 and lower limb PASI from 3.53 to 0.06, and trunk PASI from 3.48 to 0.00 by week 16. All paired comparisons between baseline and week 16 reached statistical significance (p<0.05). According to these results, over 90% of patients with scalp, genital or trunk involvement achieved complete or near-complete clearance by mid-treatment.
Nail response
Nail psoriasis showed gradual and sustained improvement. At baseline, nail involvement was assessed in 50 patients, of whom 47 presented with active nail psoriasis (NAPSI>0). The mean NAPSI score decreased from 2.96 at baseline to 0.03 at week 24. Amongst the 23 patients with available nail data at week 54, they all achieved a NAPSI score of 0 (Figure 4). A significant effect of time was observed on NAPSI scores (F statistic 8.13; p<0.001), indicating progressive improvement over follow-up.
Figure 4.
NAPSI response over time. Mean Nail Psoriasis Severity Index (NAPSI) values at baseline, week 4, week 16, week 24, and week 54. Error bars represent 95% confidence intervals (CI). The number of evaluable patients at each timepoint is reported above each marker (baseline: n=50; weeks 4–16: n=49; week 24: n=37; week 54: n=23). The reduced number of evaluable patients at week 54 reflects incomplete follow-up assessments and intermittent missing data inherent to the retrospective real-world study design. Of the 50 patients who remained under clinical follow-up through week 54, NAPSI data were available for 23. For full patient disposition details, see Figure 1.
However, early changes at week 4 were not statistically significant at the 5% level, whilst significant reductions compared with baseline emerged from week 16 onwards (Holm-adjusted p=0.001 at weeks 16 and 24; p=0.002 at week 54).
PsA subgroup
Amongst the 13 patients with PsA, musculoskeletal symptoms improved progressively over time. Mean pain VAS decreased from 28.85 at baseline to 9.54 at week 4, 3.77 at week 16, and 0.43 at week 54. Amongst patients with available laboratory data, most showed normalization of ESR and CRP by week 16. However, due to the retrospective nature of data collection and the small subgroup size, the exact number of patients with available VAS and laboratory data at each post-baseline time point could not be systematically retrieved; findings should therefore be interpreted as exploratory and hypothesis-generating only. All post-baseline time points showed statistically significant reductions compared with baseline (all Holm-adjusted p<0.001), with the largest decrease observed at week 54. No articular flares or new-onset joint symptoms were reported during follow-up.
Safety
Treatment was well tolerated. A total of 8 patients (13.6%) reported AEs, most commonly mild oral candidiasis (n=6). All events were mild, self-limiting, or resolved with topical treatment or short-course systemic therapy, and none required treatment discontinuation or dose adjustment. No serious AEs were recorded (Table 4).
Table 4.
Adverse events.
| Adverse event | n (%) | Severity | Management | Outcome | Treatment discontinuation |
|---|---|---|---|---|---|
| Oral candidiasis | 6 (10.2%) | Mild | Topical/systemic antifungal therapy | Resolved | No |
| Injection site reactionsa | 2 (3.4%) | Mild | None/topical treatment | Resolved | No |
| Any adverse event | 8 (13.6%) | Mild | – | All resolved | No |
| Serious adverse events | 0 | – | – | – | – |
Values refer to the number of patients experiencing at least one adverse event. Percentages are calculated on the total cohort (n=59).
Includes injection site pain and injection site reaction.
Discussion
This multicentre real-life study confirms the effectiveness and safety of bimekizumab in patients with moderate plaque psoriasis, a population that is frequently underrepresented in clinical trials and often undertreated in routine clinical practice. Many individuals with moderate disease receive only topical therapies, particularly in private healthcare settings, despite presenting long-standing inflammation, involvement of visible or sensitive sites, and a substantial QoL impairment. These findings support the concept that moderate psoriasis should not be considered a mild condition but rather a chronic systemic inflammatory disease that may benefit from timely systemic intervention.
The treatment response observed in this study was consistent with pivotal phase III trials such as BE READY, BE SURE and BE RADIANT, in which bimekizumab demonstrated rapid and profound reductions in disease activity with high rates of complete skin clearance.12 The dual inhibition of IL-17A and IL-17F may account for the depth and durability of clinical responses observed in both biologic-naive and biologic-experienced patients. The marked efficacy in difficult-to-treat areas, including the scalp, genital region and nails, supports the ability of bimekizumab to achieve comprehensive disease control in patients with moderate psoriasis. Improvements noted in the PsA subgroup, including reductions in pain scores and normalization of inflammatory markers, suggest a broader anti-inflammatory effect; however, larger studies are needed to further evaluate musculoskeletal outcomes.13
Bimekizumab was well tolerated, with only mild and manageable AEs reported and no treatment discontinuations, supporting its suitability and feasibility in routine clinical practice.14,15
Limitations
This study has several limitations, including its retrospective design, lack of a comparator arm, modest sample size and substantial missing data at the primary long-term end point. Notably, PASI data at week 54, the primary effectiveness end point, were available for only 19 of the 59 enrolled patients (32%), and nail (NAPSI) data at week 54 were available for 23 patients. The authors acknowledge that conclusions regarding long-term effectiveness are therefore based on a substantially reduced evaluable subset and carry a risk of attrition bias or selection bias; patients retained in follow-up may differ systematically from those lost to follow-up in terms of disease severity, treatment response or adherence.
Because data collection reflected routine clinical practice, the availability of some outcomes varied across time points; however, the use of mixed-effects models mitigates this by incorporating all available data points and avoiding the exclusion of patients with incomplete observations.
PASI was the primary index used for skin assessment and may not fully capture disease severity in patients with localized or highly visible areas of involvement.
Furthermore, patient-reported outcomes, such as longitudinal DLQI assessment and physician global assessment, were not systematically collected during follow-up, limiting the evaluation of QoL changes over time. Additionally, as noted above, nail outcome data at week 54 were available for only 23 of the 47 patients with baseline nail involvement, which may introduce selection bias in the interpretation of long-term nail responses.
Regarding the PsA subgroup analysis, the exact number of evaluable patients at each time point for pain VAS scores and inflammatory markers (ESR and CRP) could not be systematically retrieved from the retrospective records. This prevents a precise characterization of data availability within this subgroup and limits the interpretability of the observed trends. These findings should be considered hypothesis-generating and require confirmation in prospective studies with complete longitudinal data.
Finally, the definition of moderate psoriasis is not fully standardized across studies and guidelines; therefore, extrapolation of these results to other definitions of disease severity should be interpreted with caution.
Conclusions
Bimekizumab demonstrated rapid, profound and durable disease control in real-life patients with moderate plaque psoriasis, including those with nail involvement, difficult-to-treat areas and concomitant PsA.16,17 Its consistent performance across biologic-naive and biologic-experienced patients, combined with a favourable safety profile, supports early systemic intervention as a potential strategy to reduce cumulative inflammatory burden; however, long-term outcome benefits require confirmation in prospective controlled studies.18
Acknowledgements
None.
Footnotes
Contributions: FF, NB and AD made substantial contributions to the conception and design of the manuscript. EC, EG and DG contributed to the acquisition, analysis, and interpretation of the data. GC and GM contributed to the design of the manuscript and the acquisition of the data. GP contributed to the analysis and interpretation of the data. All authors participated in drafting or revising the manuscript, approved the final version, and agree to be accountable for all aspects of the work. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. The authors decline the use of artificial intelligence, language models, machine learning, or similar technologies to create content or assist with writing or editing of the manuscript.
Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2026/06/dic.2026-5-3-COI.pdf
Funding declaration: There was no funding associated with the preparation of this article.
Correct attribution: Copyright © 2026 Feresin F, Bernardini N, Campione E, Caldarola G, Gubinelli E, Moretta G, Pagnanelli G, Giordano D, Persechino S, Falco GM, Artosi F, Zappia E, Pellacani G, Potenza C, Richetta AG, De Simone C, Orsini D, Dattola A. https://doi.org/10.7573/dic.2026-5-3. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.
Provenance: Submitted; externally peer reviewed.
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Availability of data
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.