Additional Value of Ultrasound in Patients with Psoriatic Arthritis within Treatment Target.

Background: In psoriatic arthritis (PsA), musculoskeletal ultrasound is a complementary tool to physical examination, useful even in patients in remission to detect subclinical activity. Objectives: The objective of the study was to assess the ultrasound prevalence of active enthesitis and synovitis in patients who reached the therapeutic target. Methods: This cross-sectional study included patients with at least 6 months of therapy with a targeted synthetic or biological disease-modifying antirheumatic drug who were in treatment target (i.e., DAPSA < 14). Patients underwent bilateral clinical and ultrasound examination of the elbow lateral epicondyle, quadriceps insertion, distal patellar tendon insertion, and Achilles enthesis for assessing enthesitis, and hand and foot joints for assessing synovitis. Enthesitis and synovitis were considered active if the power Doppler signal showed at least a score of one. Results: The study included 51 PsA patients, women (52.9%), with an average age of 55 years. Although the patients were within the DAPSA treatment target, 21.6% had at least one painful enthesis at clinical examination, 19.6% had ultrasound evidence of at least one active enthesitis and 15.7% had ultrasound signs of at least one active synovitis. Conclusions: Among PsA patients thought to be within the therapeutic target, ultrasound detected a non-negligible percentage of active enthesitis and synovitis.

Nail Ultrasound in Psoriasis and Psoriatic Arthritis-A Narrative Review.

Ultrasonography has advantages for assessing psoriatic arthritis (PsA) due to its ability to evaluate several targets, including joints, entheses, and tendons, but also skin and nails. Although ultrasound is widely used in PsA, nail ultrasound, despite its potential as a non-invasive method for the early detection of inflammation in the nail apparatus, has low applicability in medical practice, as probes with a higher frequency are needed compared with the frequency of probes usually used. In the present article, we have narratively evaluated the studies published in the last 5 years (19 February 2018-18 February 2023) on nail ultrasound value in the diagnosis and monitoring of PsA. The studies published during this period share common measurement parameters, such as the OMERACT definition of enthesis published in 2018. We included original articles published in PubMed and Web of Science using the following search terms in all possible combinations: psoriatic arthritis, psoriasis, ultrasound, and nail. Articles were declared relevant if they presented data on nail morphology, power Doppler evaluation and nearby structure evaluation, while focusing on digitorum extensor enthesitis. In most of the studies, common morphological parameters were generally increased in patients with psoriasis or PsA and were demonstrated to change with medication. The thickness of the extensor tendon was greater in patients with PsA and psoriasis versus controls and it was correlated with nail clinical changes, especially the presence of onycholysis. The presence of PD showed large variability in healthy individuals. The link between enthesitis and nail involvement is still a subject of controversy, taking into account the latest histological findings. The use of ultrasound in the evaluation of nail and DIP enthesitis remains a challenge and an area of research in the coming years.

Comparison of Efficacy and Safety of Original and Biosimilar Adalimumab in Active Rheumatoid Arthritis in a Real-World National Cohort.

Background and Objectives: Real-world evidence should reflect the evidence obtained from controlled trials; therefore, the study aimed to compare biosimilar adalimumab (bADA) to original adalimumab (oADA) in terms of efficacy and safety in a real-life national cohort of rheumatoid arthritis (RA) patients. Materials and Methods: The following study is a prospective observational study in which we analyzed patients treated with reimbursed biologics from the Romanian Registry of Rheumatic Diseases (RRBR). RA cases must fulfill the 2010 classification criteria, as well as specific inclusion and exclusion criteria. The RRBR database was queried for all RA patients starting oADA or bADA (FKB327, GP2017, MSB11022, SB5 available) from 2 May 2019 (the first bADA initiation) until 26 March 2022 (study search date). Results: The study included 441 patients who started oADA (48.3%) or bADA (51.7%) in the same time period. At baseline, patients starting bADA had a significantly higher mean age and lower prevalence of women. After the first six months of treatment, there were no significant differences between the oADA and bADA regarding rates of Boolean (15.0% vs. 12.3%, p = 0.401), DAS28-CRP (32.4% vs. 34.2%, p = 0.686) and SDAI (16.4% vs. 14.0%, p = 0.483) remission rates. There were 107 cases of adverse events (AE): 81.3% on oADA and 18.7% on bADA. Notably, 51.4% of AE were infections. Regarding severity, 49.5% of AEs were mild, 34.6% were moderate, and 15.9% were severe. Conclusion: Biosimilar adalimumab showed similar efficacy and safety to original adalimumab after the first six months of treatment in RA patients from a national registry.

Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis - A comparison in a real-world national cohort.

OBJECTIVE: The study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA). METHODS: Data from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country. RESULTS: The study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash). CONCLUSION: Biosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.

Pregnancy Outcomes in Couples with Males Exposed to Longterm Anti-tumor Necrosis Factor-α Inhibitor Therapies: A Prospective Study.

OBJECTIVE: To examine the pregnancy achievement and outcomes in couples in which men with spondyloarthritis (SpA) were exposed to tumor necrosis factor inhibitors (TNFi). METHODS: Information about pregnancies involving fathers with SpA was prospectively collected by 6 Romanian rheumatology centers. RESULTS: Twenty-seven patients achieved 33 pregnancies and fathered 30 healthy children. Three elective abortions (personal reasons) and no spontaneous abortions, preeclampsia/eclampsia, stillbirths, congenital malformations, or pathologies in the children were recorded. Five patients showed normospermia before and after longterm TNFi treatment. CONCLUSION: Pregnancy and child outcomes in male patients with SpA exposed to longterm TNFi therapy were reassuring.