Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry.

INTRODUCTION: Inflammatory rheumatic diseases usually affect women of childbearing age treated with biologic drugs. However, there is a lack of literature on the efficacy and toxicity of biologic disease-modifying drugs during pregnancy. The aim of this study was to determine the presence of pregnant patients treated with bDMARDs in a real-world dataset and to examine the impact of pregnancy and lactation on the evolution of rheumatic disease in a registry of Spanish patients. METHOD: This was a multicentre prospective study with a real-world setting. Information was obtained from BIOBADASER registry. Patients included are women who got pregnant until November 2020 from 19 rheumatology units. We conducted proportions, means, and standard deviations (SD) to describe the study population and the use of treatments. T-test and Chi-square test were applied to assess differences between groups. RESULT: Ninety cases of pregnancy were registered (n=68 full-term pregnancies; n=22 spontaneous miscarriages). Most of the cases discontinued bDMARDs during pregnancy (78.9%) but 13 cases continued treatment during pregnancy, mainly using certolizumab pegol. These cases were obtaining better management of rheumatic disease, although the differences were not statistically significant [DAS28-CRP, 2.9 (SD: 1.6) vs. 2.0 (1.2), p=.255; DAS28-ESR, 2.2 (1.0) vs. 1.7 (.5), p=.266]. No serious adverse events were reported during pregnancy and lactation. CONCLUSION: Being pregnant is still an uncommon condition in patients with rheumatic diseases and using bDMARDs. Our results show that rheumatic disease tended to progress better during pregnancy in patients who continued to take bDMARDs.

[Validity and usefulness of echography in the carpal tunnel syndrome]. / Validez y utilidad de la ecografía en el síndrome del túnel carpiano.

OBJECTIVE: To evaluate the accuracy and utility of ultrasonography for the diagnosis of carpal tunnel syndrome (CTS). MATERIAL AND METHOD: Prospective and blind study of 75 wrists in 42 consecutive patients with suspected CTS. Electrodiagnostic testing (EDT) was used as gold standard. We measure different ultrasonographic parameters and based on a fitted receiver operating characteristic curve, we estimated post-test probabilities for the proximal, middle and distal cross-sectional area of median nerve. We analyzed interobserver and interreader reliability by 3 different explorers and 2 different readers, cost and the patient discomfort. RESULTS: Mean ultrasound measurements were significantly higher in the EDT positive group. There was a high concordance between sonography and nerve conduction. A cut-off of 9.5 mm(2) resulted in the correct classification of 83% of cases (sensitivity 88% and specificity 67%). Conversely, a cut-off of >14 mm(2) or <7 mm(2) had excellent power to rule in CTS, with a post-test probability of 100% of specificity and sensitivity respectively. The interobserver acquisition ICC was 0.915-0.980, and the inter-reader ICC was 0.912-0.987. Ultrasound cost savings in this study were €J3217.59 (€42.9 per symptomatic wrist) and the discomfort perceived by the patient was significantly lesser 6.3 vs 56 in EDT (P <.0005). CONCLUSIONS: Ultrasound median nerve crosssectional area is reliable and may be used to accurately rule in or rule out CTS. Sonography as a first-line test is cost-effective and is more satisfactory to the patients.