Patient-reported outcomes and safety in patients undergoing synovial biopsy: comparison of ultrasound-guided needle biopsy, ultrasound-guided portal and forceps and arthroscopic-guided synovial biopsy techniques in five centres across Europe

Abstract

BackgroundWe present a European multicenter study, comparing safety data and patient-reported outcomes (PRO) from patients undergoing synovial biopsy using ultrasound-guided needle biopsy (US-NB), ultrasound-guided portal and forceps (US-P&F) or arthroscopic-guided (AG) procedures.ObjectivesTo describe safety and PRO data on joint indices of pain, stiffness and swelling before and after biopsy, procedural discomfort, joint status compared with before biopsy and willingness to undergo a second biopsy for each technique and compare the three techniques. To evaluate the impact on PRO and safety data of corticosteroid therapy as part of the biopsy procedure and sequential biopsy procedures.MethodsData were collected on the day of biopsy and 7–14 days postprocedure. Joint pain, swelling and stiffness indices were recorded as 0–100 mm Visual Analogue Scale; qualitative outcome variables on five-point Likert scales. Groups were compared with linear regression, adjusting for disease activity, corticosteroid therapy and prebiopsy PRO value and accounting for repeated measurements.ResultsA total of 524 synovial biopsy procedures were documented (402 US-NB, 65 US-P&F and 57 AGSB). There were eight adverse events (1.5%) with no difference between biopsy methods (p=0.55). All PROs were improved 2 weeks postprocedure, and there were no differences in postbiopsy change in PROs between biopsy methods. Corticosteroid administration, whether intramuscular (n=62) or intra-articular (n=38), did not result in more adverse events (p=0.81) and was associated with reduction in postbiopsy swelling (p<0.01). Sequential biopsy procedures (n=103 patients) did not result in more adverse events (p=0.61) or worsening in PRO data.ConclusionOverall, our results do not suggest a significant difference in safety or patient tolerability between US-NB, US-P&F and AGSB sampling. Further, corticosteroid therapy as part of the biopsy procedure and sequential biopsies is safe and well tolerated in patients.

Efficacy, Safety, and Sample Quality of Ultrasound‐Guided Synovial Needle Biopsy in Clinical Practice and Research: A Prospective Observational Study

“…There was no aggravation of joint symptoms or US synovitis following the procedure, similarly to what was previously reported in research‐driven biopsies (14,16). We hypothesize that the slight improvement in symptoms observed, also described in a different context (16), may be due to patient satisfaction with the biopsy procedure (as discussed above) and with the overall care and attention paid by the attending physician and biopsy operator. In fact, it has been shown that patient‐reported outcomes are affected by both the clinical outcome and patient satisfaction with the healthcare experience (29,30).…”

“…The tolerability profile of US‐guided synovial biopsies was excellent, in accordance with previous studies that formally assessed this technique in a research context (14–16). We provide evidence of the remarkable tolerability of this procedure in a clinical setting, in several joints, and in a different patient population.…”

“…We reported mild adverse events, although slightly more frequent than those in previously published studies (14,16,20,21,25), and 2 moderate adverse events. Different definitions of reportable adverse events may explain these discrepancies, and we stress that in our experience most adverse events were of little clinical relevance (e.g., minor local bleeding), and there were no severe complications (e.g., hemarthrosis, infection).…”

“…US‐guided synovial biopsies have been shown to be well‐tolerated and generate good quality tissue in the context of clinical trials (14–17). A recent study by Humby et al showed that US‐guided synovial biopsies performed in a research setting were superior to blind‐needle biopsies and as successful as arthroscopy in reliably retrieving synovial tissue from large and small joints (18).…”

Six-month prospective trial in early and long-standing rheumatoid arthritis: evaluating disease activity in the wrist through sequential synovial histopathological analysis, RAMRIS magnetic resonance score and EULAR-OMERACT ultrasound score

“…Current studies are investigating whether synovial tissue analysis can be used as an instrument for personalised medicine in RA for diagnosis, prognosis and treatment stratification 1 2. The development of ultrasound-guided synovial biopsy (USGSB) as a minimally invasive, safe and well-tolerated technique for retrieving synovial tissue has accelerated research in synovial histopathology 3–5. RA synovial pathology is heterogeneous, with some patients exhibiting high levels of inflammation with infiltrating lymphoid follicles while others have a more diffuse inflammatory alterations, and some almost without inflammation 6.…”