Roque Sáenz Peña Hospital

Paroxysmal supraventricular tachycardia (PSVT) is a common episodic arrhythmia characterized by unpredictable onset and burdensome symptoms including palpitations, dizziness, chest pain, distress, and shortness of breath. Treatment of acute episodes of PSVT in the clinical setting consists of intravenous adenosine, beta-blockers, and calcium channel blockers (CCBs). Etripamil is an intranasally self-administered L-type CCB in development for acute treatment of AV-nodal dependent PSVT in a non-medical supervised setting. This paper summarizes the rationale and study design of NODE-303 that will assess the efficacy and safety of etripamil. In the randomized, double-blinded, placebo-controlled, Phase 3 RAPID trial, etripamil was superior to placebo in the conversion of single PSVT episodes by 30 minutes post initial dose when administered in the non-healthcare setting; this study required a mandatory and observed test dosing prior to randomization. The primary objective of NODE-303 is to evaluate the safety of symptom-prompted, self-administered etripamil for multiple PSVT episodes in real-world settings, without the need for test dosing prior to first use during PSVT. Secondary endpoints include efficacy and disease burden. Upon perceiving a PSVT episode, the patient applies an electrocardiographic monitor, performs a vagal maneuver, and, if the vagal maneuver is unsuccessful, self-administers etripamil 70 mg, with an optional repeat dose if symptoms do not resolve within 10 minutes after the first dose. A patient may treat up to four PSVT episodes during the study. Adverse events are recorded as treatment-emergent if they occur within 24 hours after the administration of etripamil. Efficacy endpoints include time to conversion to sinus rhythm within 30 and 60 mins after etripamil administration, and the proportion of patients who convert at 3, 5, 10, 20, 30, and 60 min. Patient-reported outcomes are captured by the Brief Illness Perception Questionnaire, the Cardiac Anxiety Questionnaire, the Short Form Health Survey 36, the Treatment Satisfaction Questionnaire for Medication and a PSVT survey. Overall, these data will support the development of a potentially paradigm-changing long-term management strategy for recurrent PSVT.

Background/Objective This study describes the impact of immunomodulatory and/or immunosuppressive (IM/IS) drugs in the outcomes of COVID-19 infection in a cohort of patients with immune-mediated inflammatory diseases (IMIDs). Methods Adult patients with IMIDs with a confirmed SARS-CoV-2 infection were included. Data were reported by the treating physician between August 13, 2020 and July 31, 2021. Sociodemographic data, comorbidities, and DMARDs, as well as clinical characteristics, complications, and treatment of the SARS-CoV-2 infection, were recorded. Descriptive analysis and multivariable logistic regression models were carried out. Results A total of 1672 patients with IMIDs were included, of whom 1402 were treated with IM/IS drugs. The most frequent diseases were rheumatoid arthritis (47.7%) and systemic lupus erythematosus (18.4%). COVID-19 symptoms were present in 95.2% of the patients. A total of 461 (27.6%) patients were hospitalized, 8.2% were admitted to the intensive care unit, and 4.4% died due to COVID-19. Patients without IM/IS treatment used glucocorticoids less frequently but at higher doses, had higher levels of disease activity, were significantly older, were more frequently hospitalized, admitted to the intensive care unit, and died due to COVID-19. After adjusting for these factors, treatment with IM/IS drugs was not associated with a worse COVID-19 outcome (World Health Organization–Ordinal Scale ≥5) (odds ratio, 1.24; 95% confidence interval, 0.73–2.06). Conclusions SAR-COVID is the first multicenter Argentine registry collecting data from patients with rheumatic diseases and SARS-CoV-2 infection. After adjusting for relevant covariates, treatment with IM/IS drugs was not associated with severe COVID-19 in patients with IMIDs. Study Registration This study has been registered in ClinicalTrials.gov under the number NCT04568421.

BackgroundMusculoskeletal Ultrasonography (US) is a suitable tool for the clinical assessment in juvenile idiopathic arthritis (JIA). Recently US definitions for normal components of pediatric joints and synovitis have been developed by the OMERACT US working group. Currently this group is working on development and validation of US definition for tenosynovitis as it is also an essential prerequisite for the reliable use of this technology in the pediatric age group.ObjectivesTo produce consensus-based definitions for US tenosynovitis in JIA through a Delphi process.MethodsWe undertook a Delphi process on US-defined tenosynovitis in children that consisted of two steps. As a prior systematic literature review showed that US anatomy of the tendons is similar to adults, a Delphi questionnaire was written based on the consensual definitions developed for and used in adults with rheumatoid arthritis [1, 2]. The Delphi questionnaire was sent to rheumatologists and pediatricians who perform pediatric US examination, asking them to rate their level of agreement with each statement of US-defined tenosynovitis. Group agreement was considered if ≥80% of responders scored an item as either 4 or 5.In the second step, the definitions were validated on 88 standardized US images displaying various degrees of tenosynovitis obtained from JIA patients at various ages. Tendons often involved in JIA were selected (foot and ankle tendons, hand and wrist tendons, bicep tendon.). US images of both normal and tenosynovitis elementary lesions were collected by the 18 experts participating in the OMERACT US task force on pediatric tenosynovitis. An agreement ≥70% was considered mandatory for accepting the definition as applicable in the rated image.ResultsThe response rate was 75% (28 out of 37) from the first Delphi questionnaire. Strong group agreement (≥86%) was obtained for the US definitions tested. The response rate was 88.9% (16 out of 18) from the Web-exercise after four rounds. The final definitions were validated on still images for all tendons, except for the biceps tenosynovitis in the age group 2-4 years (the definitions of elementary lesions and the global definition of tenosynovitis) as no image was available for this location and age group. Despite not reaching group agreement after the second and the third round for the US-defined normal finger pulley in children aged 8 years and younger (roughly 68% and 69% respectively), it reached a score of 99.8% after the fourth round.ConclusionUS definitions of tenosynovitis and its elementary components covering a wide pediatric age range were successfully developed through a Delphi questionnaire and validated in a web-based still images exercise. These results provide the basis for the standardized US assessment of tenosynovitis in clinical practice.References[1]Ultrasound in the assessment of tenosynovitis in juvenile idiopathic arthritis: systematic literature review. Collado P on behalf of the OMERACT Ultrasound Task Force. DOI: 10.1136/annrheumdis-2019-eular.3493[2]Reliability of a consensus-based ultrasound score for tenosynovitis in rheumatoid arthritis. Naredo E on behalf of the OMERACT Ultrasound Task Force. Ann Rheum Dis 2013;72:1328AcknowledgementsAG Bruyn, L Terslev, S Jousse-Joulin, A Rodriguez, M Steiner, E Inarejos, P Bøyesen, K Misaki, A Iagnocco, B Marston, T Cazenave, P Mandl, A Bruns.Disclosure of InterestsNone declared