Clinical outcomes of switching to adalimumab biosimilar (MSB11022) in patients with rheumatoid arthritis: RESTART Spanish Registry.

OBJECTIVE: MSB11022 is a biosimilar of adalimumab that has been shown comparable bioequivalence, safety, tolerability, and immunogenicity profiles to the reference adalimumab in healthy volunteers or in patients with psoriasis or rheumatoid arthritis (RA). This is the first study conducted under clinical practice conditions evaluating the switch from reference adalimumab to MSB11022 in patients with RA. METHODS: Retrospective and multicenter study with data from the medical records of patients with RA who switched from reference adalimumab or another biosimilar to MSB11022 and maintained this treatment for at least 6 months. Information registered comes from baseline visit, the moment of the switch, and the follow-up visits. RESULTS: Data from 86 patients were evaluated (median age 63.5 years, 75.6% female, 44.2% had erosive RA). Only 3.5% of the patients received biologic therapy prior to adalimumab. At baseline, median DAS28-CRP was 1.77 (80.2% in remission and 96.5% with low disease activity) and median CDAI was 4.00 (44.2% in remission and 90.7% with low disease activity). After a median follow-up of 8 months, median DAS28-CRP was 1.87 (86.0% in remission and 94.2% with low disease activity) and median CDAI was 4.00 (38.5% in remission and 95.3% with low disease activity). Only three patients experienced pain, swelling, and stinging at the injection site or a locally extensive hematoma in the area of administration. CONCLUSIONS: Adalimumab biosimilar MSB11022 maintained the efficacy benefits provided by previous adalimumab treatments with a safety profile in line with that already described for other biosimilars.

Influence of the EULAR recommendations for the use of imaging in large vessel vasculitis in the diagnosis of giant cell arteritis: results of the ARTESER register.

OBJECTIVE: The main study objective was to determine how giant cell arteritis (GCA) is diagnosed in our clinical practice and whether the EULAR recommendations have influenced the diagnostic procedures used. METHODS: ARTEritis of the Rheumatology Spanish Society -Sociedad Española de Reumatología (ARTESER) is a multicentre observational retrospective study conducted in 26 hospitals with support from the Spanish Society of Rheumatology. All patients diagnosed with GCA between 1 June 2013 and 29 March 2019 were included. The gold standard for the diagnosis of GCA was the judgement of the physician in charge, according to clinical criteria, supported by data available from laboratory tests, imaging studies (ultrasound, positron emission tomography (PET) and MRI/CT angiography) and temporal artery biopsy (TAB) when available. RESULTS: We included 1675 patients with GCA (mean age±SD (76.9±8.1) years, 1178 women (70.3%)). Of these, 776 patients had a positive TAB (46.3%), 503 (30.0%) positive ultrasound, 245 positive PET (14.6%) and 64 positive MRI/CT angiography (3.8%). These percentages changed substantially over the study. From 2013 to 2019, the use of ultrasound in diagnosis grew from 25.8% to 52.9% and PET from 12.3% to 19.6%, while use of TAB decreased from 50.3% to 33.3%. CONCLUSIONS: Biopsy was the most widely used diagnostic test for confirming GCA, but use of imaging as a diagnostic tool has grown in recent years. Following publication of the 2018 EULAR recommendations, ultrasound has displaced biopsy as the first-line diagnostic test; TAB was performed in a third and PET in a fifth of cases.

Ecografía Doppler de arterias temporales superficiales en la arteritis de células gigantes en una cohorte con alta sospecha clínica / Doppler ultrasonography of superficial temporal artery in a cohort of patients with strong clinical suspicion of giant cell arteritis

Fundamento y objetivo: La arteritis de células gigantes (ACG) es la vasculitis sistémica más frecuente en adultos. En los últimos años, existe un interés creciente en evaluar la utilidad de la ecografía de arterias temporales superficiales (EATS), que permite valorar la inflamación de la pared vascular. Material y métodos: Estudio de cohorte observacional y descriptivo de 120 EATS a 60 pacientes con sospecha clínica de ACG según criterios clásicos de ACR (American College of Rheumatology). Resultados: De todos los pacientes a quienes se les realizó la EATS, el 42,3% presentó diagnóstico de ACG según los criterios de clasificación ACR. La sensibilidad y la especificidad de la ecografía en nuestra cohorte de pacientes con alta sospecha clínica fueron de 81,8 y 93,3%, respectivamente, con un VPP de 90,1% y un VPN de 87,5%. Conclusión: Los resultados avalan la ecografía de arteria temporal bilateral como una técnica útil, indolora, rápida, accesible, de alta especificidad y amplia validez diagnóstica

Background and objective: Giant cell arteritis (GCA) is the most frequent systemic vasculitis in adults. In recent years, the usefulness of temporal artery ultrasound (TAUS) as a diagnostic tool to assess the underlying inflammation of the vascular wall during the inflammatory process has been under clinical investigation. Material and methods: Observational and descriptive cohort study of 120 TAUS in 60 patients with clinical suspicions of GCA, according to the ACR (American College of Rheumatology) classification criteria. Results: Among all patients who underwent ultrasound, 42.3% met clinical criteria for GCA according to ACR. Sensitivity and specificity of TAUS in our cohort with clinical suspicion was 81.8% and 93.3%, respectively. A PPV of 90.1% and a VPN of 87.5% were observed. Conclusion: Our results showed that TAUS as a useful, indolent, fast, and accessible tool with high diagnostic specificity and diagnostic value

Doppler ultrasonography of superficial temporal artery in a cohort of patients with strong clinical suspicion of giant cell arteritis. / Ecografía Doppler de arterias temporales superficiales en la arteritis de células gigantes en una cohorte con alta sospecha clínica.

BACKGROUND AND OBJECTIVE: Giant cell arteritis (GCA) is the most frequent systemic vasculitis in adults. In recent years, the usefulness of temporal artery ultrasound (TAUS) as a diagnostic tool to assess the underlying inflammation of the vascular wall during the inflammatory process has been under clinical investigation. MATERIAL AND METHODS: Observational and descriptive cohort study of 120 TAUS in 60 patients with clinical suspicions of GCA, according to the ACR (American College of Rheumatology) classification criteria. RESULTS: Among all patients who underwent ultrasound, 42.3% met clinical criteria for GCA according to ACR. Sensitivity and specificity of TAUS in our cohort with clinical suspicion was 81.8% and 93.3%, respectively. A PPV of 90.1% and a VPN of 87.5% were observed. CONCLUSION: Our results showed that TAUS as a useful, indolent, fast, and accessible tool with high diagnostic specificity and diagnostic value.