| Title: |
Italian Multicenter Real-World Study on the Twelve-Month Effectiveness, Safety, and Retention Rate of Guselkumab in Psoriatic Arthritis Patients |
| Authors: |
Atzeni F.; Rotondo C.; Siragusano C.; Corrado A.; Cauli A.; Caporali R.; Chimenti M. S.; Conti F.; Picerno V.; Gremese E.; Camarda F.; Guiducci S.; Ramonda R.; Idolazzi L.; Semeraro A.; Sebastiani M.; Lapadula G.; Ferraccioli G.; Iannone F. |
| Contributors: |
Atzeni, F.; Rotondo, C.; Siragusano, C.; Corrado, A.; Cauli, A.; Caporali, R.; Chimenti, M. S.; Conti, F.; Picerno, V.; Gremese, E.; Camarda, F.; Guiducci, S.; Ramonda, R.; Idolazzi, L.; Semeraro, A.; Sebastiani, M.; Lapadula, G.; Ferraccioli, G.; Iannone, F. |
| Publication Year: |
2025 |
| Collection: |
Università degli Studi di Cagliari: UNICA IRIS |
| Subject Terms: |
drug survival; efficacy; Il-23 inhibitor; psoriatic arthriti; safety |
| Description: |
Background/Objectives: Psoriatic arthritis (PsA) is a chronic inflammatory condition that primarily affects the musculoskeletal system and skin. While biologic and targeted synthetic DMARDs have improved treatment, many patients still fail to achieve remission. Combining conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) with biologic (b) DMARDs or targeted synthetic (ts) DMARDs shows no added benefit over monotherapy with IL-17, IL-23 inhibitors, or JAK inhibitors, unlike TNFi, which benefit from csDMARD co-administration. Guselkumab (GUS) and risankizumab (RKZ) target IL-23 with high specificity. RCTs (DISCOVER 1 and 2, COSMOS) have confirmed GUS efficacy regardless of methotrexate (MTX) use, though liver toxicity was higher with MTX. Real-world data on GUS remain limited, with gaps in understanding its long-term effectiveness and drug survival. The aim of this study is to assess the following three points within a multicenter Italian real-life cohort of PsA patients treated with guselkumab (GUS) and followed for 12 months: (1) effectiveness and safety of GUS; (2) drug retention rate (DRR) and reasons for discontinuation; (3) impact of comorbidities on achieving minimal disease activity (MDA). Methods: This study utilized data from the GISEA registry, which includes centers in different parts of Italy (north, center, south, and islands), and included patients aged 18 and older diagnosed with PsA according to the CASPAR criteria. Results: Data on 170 PsA patients treated with GUS were collected. In the first 6 months, a prompt mean percentage improvement in all clinimetric indexes was observed compared to the baseline. At 6-month follow-up, ACR 20 was reached by 60% of patients, ACR 50 by 30%, ACR 70 by 15%, MDA by 28%, and DAPSA < 14 by 50% of patients in the overall group. Significant differences were found in the rate of ACR 50 in the bDMARD-naive group (50%) compared to one bDMARDs non-responder (NR) (8%) (p = 0.021). At 12-month follow-up, a notable gap was observed in the rate of ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40565857; info:eu-repo/semantics/altIdentifier/wos/WOS:001517092600001; volume:14; issue:12; journal:JOURNAL OF CLINICAL MEDICINE; https://hdl.handle.net/11584/460946 |
| DOI: |
10.3390/jcm14124111 |
| Availability: |
https://hdl.handle.net/11584/460946; https://doi.org/10.3390/jcm14124111 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.5AC413AE |
| Database: |
BASE |