Search Results (214)

This study examined the distribution and disease associations of non-HLA-B*27 HLA-B alleles in Romanian spondyloarthritis (SpA) patients, aiming to address the underrepresentation of Eastern European populations in immunogenetic research. Methods: We analyzed 263 HLA-B*27-negative patients from Northeastern Romania fulfilling ASAS criteria. HLA-B genotyping was performed at two-digit resolution, and allele distributions were compared with two Romanian HLA-B*27-negative control groups (n = 335 and n = 1705 cases), using chi-square testing and logistic regression. Compared to controls, HLA-B*47 (p = 0.0007) and HLA-B*54 (p = 0.0013) were significantly enriched, while HLA-B*40 was underrepresented (p = 0.0287). Notably, HLA-B*54 was observed exclusively in axial SpA. Within the cohort, both HLA-B*13 and HLA-B*57 alleles were associated with psoriasis, while HLA-B*37 and HLA-B*41 alleles were clustered within the reactive arthritis group. The HLA-B*35 and HLA-B*18 alleles were the most frequently observed alleles across most clinical phenotypes. When comparing the frequency of HLA-B associations, the most common genotypes among SpA patients were B*08-B*18, B*13-B*35, and B*35-B*51. Notably, B*08-B*18 was more frequent in patients with radiographic sacroiliitis grade ≥ 2, while B*35-B*51 was more frequent in those with confirmed systemic inflammation, as indicated by elevated CRP or ESR levels. Analysis of peptide-binding patterns revealed a cluster of risk alleles, HLA-B*08, B*18, B*35, B*40, and B*54, sharing similar features, distinct from the canonical profile of B*27. These findings highlight the contribution of non-B*27 HLA-B alleles to SpA susceptibility in an Eastern European population and support the notion that HLA-B*27-negative SpA may represent a distinct clinical and immunological entity, driven by alternative pathogenic mechanisms. They also emphasize the importance of population-specific immunogenetic profiling and support expanding genetic characterization in HLA-B*27-negative patients. Full article

Considering the high plasticity of FoxP3⁺ regulatory T (Treg) cells and Interleukin (IL)-17-producing Th17 cells, we hypothesized that a Th17 inflammatory milieu may impair the functional properties of Treg cells in chronic inflammatory arthritides. Therefore, a cross-sectional explorative analysis was set up in patients with psoriatic arthritis (PsoA), rheumatoid arthritis, or spondyloarthritis to investigate the features of Th17 and Treg cells. T cell subpopulation counts, FOXP3 mRNA expression, CpG methylation of the FOXP3 gene, and the suppressive capacity of isolated Treg cells were determined. Ex vivo analysis of PsoA-derived peripheral blood lymphocytes showed a Th17-mediated inflammation. It was accompanied by demethylation of the FOXP3 promotor and Treg-specific demethylated region (TSDR) in Treg cells which, however, resulted neither in elevated FOXP3 mRNA expression nor in increased suppressive Treg cell capacity. To clarify this conundrum, in vitro stimulation of isolated Treg cells with Th17-inducing cytokines (IL-1β, IL-6, IL-23, TGFβ), recombinant IL-17, or the anti-IL-17A antibody secukinumab was performed, demonstrating that cell culture conditions polarizing towards Th17, but not IL-17 itself, impair the suppressive function of Treg cells, accompanied by diminished FOXP3 mRNA expression due to hypermethylation of the FOXP3 promotor and TSDR. This potential causal relationship between Th17 inflammation and impaired Treg cell function requires attention regarding the development of immunomodulatory therapies. Full article

Background: Personalized medicine in axial spondyloarthritis (axSpA) requires accurate tools to assess inflammation and tailor disease monitoring. The role of traditional biomarkers such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) remains controversial due to limited sensitivity and variability across disease profiles. Objective: To compare the performance of ESR and CRP in different clinical scenarios of axSpA, including disease activity, functional impact, severity, disease duration, and exposure to biologic therapy. Methods: We conducted a cross-sectional analysis of 330 patients with axSpA. Correlations among ESR, CRP, and composite disease indices were evaluated. The discriminatory capacity of each biomarker for relevant clinical thresholds was analyzed using ROC curves and optimal cut-offs identified by the Youden index. Results: ESR showed broader correlations with disease impact and activity scores than CRP. While both markers had low sensitivity overall, they were highly specific for identifying patients with very high disease activity in select scenarios. ESR ≥ 8.5 mm/h and CRP ≥ 1.88 mg/dL were strongly discriminatory in patients not exposed to biologics. CRP ≥ 0.56 mg/dL showed good performance in early disease. Conclusions: Both ESR and CRP provide complementary insights into disease activity in axSpA. ESR may offer a broader reflection of disease burden beyond inflammation. These results support a more personalized biomarker strategy in real-world axSpA management, adapted to patient profile and treatment context. Full article

Background: Secukinumab is a fully human monoclonal antibody that targets interleukin (IL)-17A and is used to treat axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). Treating axSpA and PsA can be challenging in patients with comorbidities. In this multicenter retrospective study, we aimed to evaluate the efficacy and safety of secukinumab treatment in patients with axSpA and PsA who had a history of tuberculosis, multiple sclerosis (MS), or congestive heart failure (CHF). Methods: The study included 44 patients with a diagnosis of axSpA and PsA and a history of tuberculosis, MS, or CHF who received secukinumab treatment at 13 centers in our country. Erythrocyte sedimentation rate, C-reactive protein (CRP), Bath Ankylosing Spondylitis Disease Activity Index, Ankylosing Spondylitis Disease Activity Score CRP, visual analog scale, and Disease Activity Score-28 CRP markers at months 0, 3, and 12 of secukinumab treatment were analyzed. Alongside this, tuberculosis, MS, and CHF were evaluated at follow-up using clinical assessments and imaging methods such as chest radiographs, brain magnetic resonance, and echocardiography. Results: A statistically significant improvement in inflammatory markers and disease activity scores was observed in patients treated with secukinumab. There was no reactivation in patients with a history of tuberculosis. In most MS patients, the disease was stable, while clinical and radiological improvement was observed in one patient. No worsening of CHF stage was observed in patients with a history of CHF. Conclusions: With regular clinical monitoring, secukinumab may be an effective and safe treatment option for axSpA and PsA patients with a history of tuberculosis, MS, or CHF. Full article

Objectives: We wished to evaluate the safety profile of the Janus kinase (JAK) inhibitors used in the Spanish population; to study the onset of major adverse cardiovascular events (MACEs) and thrombotic events (arterial and venous); and to analyze the factors associated with the onset of these events. Methods: We conducted a retrospective observational study of a cohort of patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA) included in the biological therapy registry of the Rheumatology Department of Virgen Macarena University Hospital (HUVM), Seville, Spain, who started targeted treatment between 2019 and late 2024. We collected data on disease activity, traditional cardiovascular risk factors, the Charlson comorbidity index, previous synthetic or biologic drug therapy, the use of corticosteroids (and their dose), severity data (structural damage, extra-articular manifestations), and adverse events at the end of follow-up (e.g., MACEs, infections, neoplasms, and herpes zoster). We performed a descriptive bivariate analysis and a multivariate logistic regression analysis (dependent variable: MACEs) to identify factors that were independently associated with MACEs. Results: The study population comprised 137 patients (110 with RA, 18 with PsA, and 9 with SpA) who were followed up for a mean of 3.9 (2.6) years. Most patients had received JAK inhibitors as their second-line or subsequent treatment. At the end of the follow-up, 82 patients (66.7%) continued their treatment. Nine patients (6.6%) experienced a MACE, and five experienced a heart attack. All of these patients had RA. We found no differences between JAK inhibitors in terms of the incidence of the adverse events studied. Patients who experienced MACEs were more often male and smokers (current or former) and more often had hypertension and diabetes. No significant differences were found in the association with disease activity or previous or concomitant treatment. The factors that were independently associated with MACEs were a previous cardiovascular event (OR, 10.74; 95%CI, 1.05–113.7; p = 0.036), male sex (OR, 9.7; 95%CI, 1.6–76.5; p = 0.016), diabetes mellitus (OR, 10.3; 95%CI, 1.75–83; p = 0.013), and the duration of treatment with JAK inhibitors (OR, 1.47; 95%CI, 1.13–2.01; p = 0.005). Conclusions: We found no differences in the onset of adverse events, specifically MACEs, between the different JAK inhibitors analyzed. These events are more common in patients who already have cardiovascular risk factors, such as diabetes mellitus, or who have already experienced a cardiovascular event. JAK inhibitors broadly suppress cytokines in patients whose disease is refractory to other treatments. However, we must continue to evaluate their long-term safety in real-world studies. Full article

Background/Objectives: The prevalence of inflammatory bowel disease (IBD) in spondyloarthritis (SpA) patients is unknown. Our objective was to assess the prevalence of undiagnosed IBD in SpA patients, including those with axial spondylarthritis (axSpA) or psoriatic arthritis (PsA). Additionally, we examined fecal calprotectin (FC) levels in relation to the accuracy of IBD diagnosis. Methods: EISER was a cross-sectional, multicenter, observational, rheumatologist–gastroenterologist collaborative study. Patients with SpA naïve to biologics were recruited. Demographic and clinical characteristics, disease activity, and treatment information were collected. Patients with FC ≥ 80 µg/g or IBD-related symptoms underwent a colonoscopy or video capsule endoscopy. Receiver operating characteristic analysis assessed the predictive value of FC for IBD diagnosis. Results: Of the 570 patients recruited, 494 were evaluable for the main outcome, 248 (50.2%) had axSpA, and 246 (49.8%) had PsA. Overall, 28/494 patients were diagnosed with IBD (5.7%, 95%CI 3.6–7.7). Sorted by clinical entity, 22 (8.9%, 95%CI 5.3–12.4) axSpA and 6 (2.4%, 95%CI 0.5–4.4) PsA patients had a diagnosis of IBD: 24 (86%, 95%CI 79.4–92.6) had ileal/ileocolonic Crohn’s disease (CD), 3 (11%, 95%CI 5.1–16.9) unclassified IBD, and 1 (3.5%, 95%CI 0.0–6.9) ulcerative colitis. The ROC curve for FC and IBD diagnosis (AUC: 0.870, p < 0.001, 95%CI 83.7–89.8) showed that an FC ≥ 147 µg/g had a positive predictive value of 17.4% (95%CI 14.5–20.8) Conclusions: In SpA, the prevalence of undiagnosed IBD was 5.7%, higher in axSpA (8.9%) than in PsA (2.4%) patients, with CD being the most common. SpA patients with FC levels < 147 µg/g had a very low probability of IBD. Full article

Objectives: We aimed to investigate the factors associated with changes in the global functioning of patients with axial spondyloarthritis (axSpA) and to identify predictors of improvement. Methods: One-hundred-and-eighty-five patients enrolled in the Incheon Saint Mary’s axSpA prospective observational cohort were evaluated. Global functioning was assessed at baseline and at 1-year follow-up using the ASAS health index (HI). Improvement was defined as a reduction in the ASAS HI of ≥3. Physical function was assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI). Disease activity measures included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS), and C-reactive protein (CRP) levels. Predictors of improved global functioning were identified by logistic regression analysis. Results: Nineteen patients (10%) showed improved global functioning at 1-year follow-up versus baseline. Univariate linear regression analysis identified body mass index at baseline, the use of TNF inhibitors, a change in the BASFI and BASDAI, and changes in CRP levels as being associated with changes in the ASAS HI. Multivariate analysis revealed that changes in the BASFI and BASDAI were associated independently with a change in the ASAS HI. Univariate logistic regression analysis revealed that a decrease in the BASFI, BASDAI, ASDAS, and CRP levels predicted improved global functioning. Multivariate analysis identified a decrease in the BASFI and BASDAI as a significant predictor of improved global functioning (odds ratio (95% CI) = 1.465 (1.006–2.135) and 1.414 (1.044–1.914), respectively). Conclusions: Changes in physical function and disease activity were associated independently with changes in global functioning assessed by the ASAS HI in axSpA. A decrease in the BASFI and BASDAI was a significant predictor of improvement in the ASAS HI. Full article

Objective: The Neutrophil–Lymphocyte Ratio (NLR) has been proposed as an inflammatory biomarker in several diseases, including Fibromyalgia, with controversial results. The objectives of this study were to: (1) compare NLR values among participants with Fibromyalgia, Axial Spondyloarthritis, and healthy controls; (2) assess the relationship between NLR and disease activity; and (3) establish diagnostic and activity cut-off values. Methods: A total of 112 age and gender-matched participants were included in each group. NLR values were compared between groups, correlations with disease activity were analyzed, and cut-off values were calculated using Receiver Operating Characteristic (ROC) curves. Results: The NLR was significantly higher in Fibromyalgia patients compared with healthy controls (1.8 ± 0.5 vs. 1.4 ± 0.2; p < 0.001) and in Axial Spondyloarthritis patients compared with both Fibromyalgia patients (2.1 ± 0.3 vs. 1.8 ± 0.5; p < 0.001) and healthy controls (2.1 ± 0.3 vs. 1.4 ± 0.2; p < 0.001). Within disease groups, the NLR was also significantly higher in patients with severe Fibromyalgia (FIQ ≥ 59) compared with non-severe cases (1.9 ± 0.5 vs. 1.7 ± 0.4; p = 0.008) and in patients with high/very high Axial Spondyloarthritis activity compared with those with low/inactive disease (2.3 ± 0.3 vs. 1.9 ± 0.2; p < 0.001). ROC analysis identified the NLR cut-off values of 1.54 for Fibromyalgia diagnosis, 1.64 for severe disease, 1.61 for Axial Spondyloarthritis diagnosis and 1.95 for high/very high disease activity. Conclusions: The NLR may serve as a cost-effective, rapid, and accessible biomarker for establishing diagnosis and disease activity in Axial Spondyloarthritis and, to a lesser extent, in Fibromyalgia. Further research is needed to validate these findings and explore NLR’s role alongside other inflammatory markers. Full article

Background: Juvenile spondyloarthritis (JSpA) is a heterogeneous group of diseases. An international consensus group developed the axial juvenile SpA (AxJSpA) classification criteria for this purpose, defining a homogeneous group of patients diagnosed with jSpA and experiencing axial symptoms before the age of 18 years. Aim: To validate this new set of criteria in our pediatric SpA patients. Methods: This study was held in the Hacettepe University Department of Pediatric Rheumatology. Juvenile SpA patients suspected of axial disease diagnosed and followed at the same center between 2005 and 2024 were included. Patients who had other etiologies for axial symptoms, including chronic nonbacterial osteomyelitis, mechanical back pain–overuse injuries, amplified pain/growing pains, and SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, and osteitis) served as the control group. Results: In total, 123 JSpA patients and 74 controls were included in this study. The sensitivity/specificity of the new criteria were 61%/77% with an area under curve value of 0.75 (95% CI: 0.68–0.83) in our cohort. Among different criteria sets, European Spondyloarthropathy Study Group (ESSG) criteria were the most sensitive (sensitivity/specificity 91%/68%), and ASAS peripheral criteria (Assessment of SpondyloArthritis International Society) were the most specific (sensitivity/specificity 67%/84%) in our cohort when compared to ASAS axial criteria (sensitivity/specificity 74%/65%), ILAR (International League of Associations for Rheumatology) (sensitivity/specificity 85%/81%), and ILAR + SI (sacroiliitis) (sensitivity/specificity 67%/74%) criteria. Conclusions: The area under the curve of the new AxJSpA criteria was similar to that of the original report; however, both sensitivity and specificity were lower in our cohort, possibly due to factors like earlier disease presentation and a lower prevalence of chronic structural changes on MRI. Full article

The extensive research and studies conducted over the past decade have greatly improved our comprehension of the pathogenesis and risk factors associated with Spondyloarthritis (SpA). In addition, they have contributed to the advancement of novel therapeutic approaches. Although genetics still represents the primary risk factor for SpA, increasing evidence presented in this review suggests that environmental factors—such as air pollution, smoking, gut microbiota (GM), infections, and diet—also contribute to its pathogenesis. In detail, environmental particulate matters (PMs), which include ligands for the aryl hydrocarbon receptor—a cytosolic transcription factor responsive to toxic substances—facilitate the differentiation of T Helper 17 (Th17) cells, potentially exacerbating the autoinflammatory processes associated with SpA. Furthermore, smoking influences both the cellular and humoral aspects of the immune response, resulting in leukocytosis, impaired leukocyte functionality, and a decrease in various cytokines and soluble receptors, including interleukin (IL) 15, IL-1 receptor antagonist (IL-1Ra), IL-6, soluble IL-6 receptor (sIL-6R), as well as the vascular endothelial growth factor (VEGF) receptor. Studies have indicated that patients with SpA exhibit an increased prevalence of antibodies directed against a conserved epitope shared by the human leukocyte antigen B27 (HLA-B27)- and Klebsiella nitrogenase, in comparison to HLA-B27-positive controls. Additionally, current evidence regarding the GM suggests the presence of a gut–joint–skin axis, wherein the disruption of the mucosal barrier by specific bacterial species may enhance permeability to the gut-associated lymphoid tissue (GALT), resulting in localized inflammation mediated by Th1 and Th17 cells, as well as IL-17A. Finally, this review discusses the role of diet in shaping the microbial composition and its contribution to the pathogenesis of SpA. A comprehensive understanding of the mechanisms by which environmental factors influence the pathogenesis and progression of the disease could facilitate the development of novel personalized therapies targeting both external and internal environmental exposures, such as the gut microbial ecosystem. Full article

Background and Objectives: The objective of our study was to describe the biopsychosocial profile of individuals diagnosed with axial spondyloarthritis (AxSpA) and to analyze how their clinical characteristics interact with disease activity. Materials and Methods: An observational study was conducted, involving 28 participants diagnosed with AxSpA. We evaluated clinical outcomes (perceived pain, range of motion [RoM], pressure pain threshold [PPT], and proprioceptive acuity), psychosocial outcomes (the Pain Catastrophizing Scale [PCS], Tampa Scale of Kinesiophobia [TSK-11], and the Fear-Avoidance Beliefs Questionnaire [FABQ]), and AxSpA-specific indices (the Bath Ankylosing Spondylitis Metrology Index [BASMI], Bath Ankylosing Spondylitis Functional Index [BASFI], and Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Data were analyzed using Spearman’s correlation coefficients and simple and multiple linear regression models. Results: Cervical and lumbar RoM values were reduced compared to established normative values for the general population. Significant associations were found between perceived pain, pain catastrophizing, and FABQ scores with both BASDAI and BASFI (p < 0.05). The interaction between perceived pain and pain catastrophizing (p < 0.001) accounted for 45.7% of the variance in BASDAI, while the interaction between perceived pain and FABQ (p < 0.001) explained 52.1% of the variance in BASDAI. Conclusions: The biopsychosocial profile of patients with AxSpA is characterized by moderate-intensity perceived pain and reduced cervical and lumbar mobility. The observed associations between BASDAI, pain catastrophizing, and fear-avoidance beliefs underscore the influence of psychosocial factors on disease progression. Full article

Selenium (Se) is an essential micronutrient for antioxidant defense. Selenoproteins are involved in metabolic and signaling pathways of autoimmune and autoinflammatory diseases. Copper (Cu) and zinc (Zn) are integral components of key enzymes and regulatory proteins. Trace element (TE) dysregulations have potential relevance as disease biomarkers. In this study, we compare TE status and TE profiles between patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), and relate the results to markers of inflammation, remission, and healthy controls. Serum TE was measured using total reflection X-ray fluorescence. The Se transporter SELENOP and extracellular glutathione peroxidase (GPx3) were determined by ELISA and enzymatic assay, respectively. Both groups of patients (axSpA; n = 84, and PsA; n = 76) displayed TE deficiency compared to healthy European adults. Serum Cu, Se, Zn, SELENOP, and GPx3 levels were not different between the groups. The serum Cu and Cu-Zn ratio correlated positively with C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). An inverse correlation of serum Se, Zn, and SELENOP with CRP was observed in axSpA, but not in PsA. On average, all TE, including the inflammation-responsive Cu levels, were below reference ranges, indicating a TE deficiency in both groups. Increasing CRP was associated with low SELENOP levels, suggesting personalized Se substitution as indicated to maintain systemic Se supply and protect from ferroptotic cell loss under inflammatory conditions. Full article

Objective: The aim of this study was to assess and compare the diagnostic accuracy of two MRI techniques for identifying structural bone lesions (fatty lesions [BMFs], subchondral erosions [BMEs], sclerosis [BMS], and ankylosis [A]) in the dorso-lumbar joints. This assessment specifically focused on the application of MRI Dixon sequence fat–water separation techniques (T2w Dixon FSTs) when acquiring T1-weighted (T1w) images as the reference standard, among patients diagnosed with axial spondyloarthritis (SpA). Methods: Conducted at a single center, this study involved the recruitment of patients who underwent both spinal and sacroiliac (SI) joint MRI between 2019 and 2022, with follow-up continuing until 2023. In 2023, three independent readers reassessed the initial MRI datasets to evaluate specific radiological features of SpA. They recorded confidence estimates regarding the use of T2w Dixon FSTs when acquiring T1w images. The centralized MRI interpretations were then compared to established rheumatologic diagnoses. Results: A total of 73 patients (42 men and 31 women) were included in the study. The mean sensitivity, specificity, and accuracy of T2w Dixon FSTs (fat-only images) were at least 75%, 100%, and 96%, respectively, based on the 2023 assessment for all considered items. The diagnostic performance of T2w Dixon FSTs was comparable to that of T1w images. Conclusions: The diagnostic performance of T2w Dixon FSTs (fat-only images) matched that of T1w images not only in assessing structural and fatty lesions, but also in the evaluation of subchondral erosions, sclerosis, and ankylosis in the dorso-lumbar joints of patients with a rheumatologic diagnosis of SpA. These findings suggest the potential avoidance of T1-weighted images when employing multi-parameter, multi-sequence imaging, such as the Dixon sequence. Full article

Spondyloarthropathies (SpAs) represent a diverse group of seronegative immune-mediated inflammatory diseases characterized by a genetic predisposition and an association with human leukocyte antigen-B27. This narrative review aims to explore juvenile spondyloarthropathies (JSpAs), their classification, clinical manifestations, diagnostic challenges, and contemporary treatment strategies. According to the International League of Associations for Rheumatology criteria, JSpAs include several specific forms: enthesitis-related arthritis, psoriatic arthritis, and undifferentiated arthritis. Despite established classifications, the terms and definitions surrounding these conditions can often lead to confusion among healthcare professionals. This ambiguity underscores the need for a standardized approach to nosological classification. The clinical presentation of JSpAs can be multifaceted, encompassing both articular and extra-articular manifestations. Articular symptoms may include enthesitis and varying forms of arthritis, while extra-articular involvement can range from uveitis to gastrointestinal, cardiovascular, pulmonary, neurological, and renal complications. These diverse manifestations highlight the systemic nature of the disease and the importance of a holistic approach to diagnosis and treatment. While laboratory tests for SpAs are often non-specific, imaging modalities such as musculoskeletal ultrasound and magnetic resonance imaging play a crucial role in the early detection of inflammatory lesions. These imaging techniques can provide valuable insights into disease progression and aid in the formulation of appropriate treatment plans. Current treatment guidelines advocate for a “stepwise” approach to therapy, beginning with nonsteroidal anti-inflammatory drugs and progressing to glucocorticoids, disease-modifying antirheumatic drugs, and biological agents, particularly anti-tumor necrosis factor alpha agents. The primary objective of treatment is to achieve clinical remission or, at a minimum, to attain low disease activity. Regular monitoring of disease activity is imperative; however, the lack of validated assessment tools for the pediatric population remains a significant challenge. JSpAs pose unique challenges in terms of diagnosis and management due to their diverse manifestations and the complexities of their classification. Ongoing research and clinical efforts are essential to refine our understanding of these conditions, improve treatment outcomes, and enhance quality of life for affected children and their families. Effective management hinges on early detection, individualized treatment plans, and continuous monitoring, ensuring that patients receive the most appropriate care tailored to their specific needs. Full article

Background: Axial involvement in psoriatic arthritis (axPsA) presents clinical and radiological differences from ankylosing spondylitis (AS), which may influence the therapeutic response. While Guselkumab has demonstrated efficacy in peripheral PsA, its role in axPsA is less well established, particularly in real-world settings. Objective: To evaluate the positive effects of Guselkumab therapy in patients with psoriatic arthritis (PsA), 58.6% of whom have axial involvement, in a 12-month, single-center, longitudinal, prospective observational cohort study conducted in a real-life setting. Methods: A cohort of 99 patients with PsA, including 58 with axial involvement (axPsA), was treated with Guselkumab for 12 months. Treatment efficacy was assessed by evaluating the reduction in mBASDAI, ASDAS, DAPSA, VAS Pain, LEI, and HAQ scores. The Friedman test was used to analyze whether the overall changes from baseline to 12 months were statistically significant. Patients with axial involvement were assessed by MRI, with scores measured at baseline (t₀), after 6 months (t₆), and after 12 months (t₁₂) of therapy. Statistical evaluation was conducted using the Friedman test, followed by pairwise comparisons of values obtained at different follow-up time points using the Wilcoxon signed-rank test. Additionally, the drug’s retention rate was examined using a Kaplan–Meier curve. Results: After 12 months of therapy, a statistically significant reduction was observed in all clinimetric parameters. Patients with axial involvement were also evaluated by MRI at baseline, after 6 months, and after 12 months of therapy. MRI images showed a reduction in bone marrow edema and a decrease in signal intensity, indicating a significant reduction in inflammation and confirming the drug’s efficacy. Retention rate values demonstrate that Guselkumab is well tolerated and effective in the long term for the majority of patients. Conclusions: This 12-month real-world study of 99 PsA patients confirms the efficacy of Guselkumab in reducing disease activity in both peripheral and axial forms. The findings align with previous RWE and clinical trials (DISCOVER-1 and -2), supporting its clinical utility in PsA and axPsA, with high treatment retention. Full article