RESUMO
BACKGROUND: The understanding of non-radiographic axial spondyloarthritis (nr-axSpA) has accelerated over the last decade, producing a number of practice-changing developments. Diagnosis is challenging. No diagnostic criteria exist, no single finding is diagnostic, and other causes of back pain may act as confounders. AIM: To update and expand the 2014 consensus statement on the investigation and management of non-radiographic axial spondyloarthritis (nr-axSpA). METHODS: We created search questions based on our previous statements and four new topics then searched the MEDLINE and Cochrane databases. We assessed relevant publications by full-text review and rated their level of evidence using the GRADE system. We compiled a GRADE evidence summary then produced and voted on consensus statements. RESULTS: We identified 5145 relevant publications, full-text reviewed 504, and included 176 in the evidence summary. We developed and voted on 22 consensus statements. All had high agreement. Diagnosis of nr-axSpA should be made by experienced clinicians, considering clinical features of spondyloarthritis, blood tests, and imaging. History and examination should also assess alternative causes of back pain and related conditions including non-specific back pain and fibromyalgia. Initial investigations should include CRP, HLA-B27, and AP pelvic radiography. Further imaging by T1 and STIR MRI of the sacroiliac joints is useful if radiography does not show definite changes. MRI provides moderate-to-high sensitivity and high specificity for nr-axSpA. Acute signs of sacroiliitis on MRI are not specific and have been observed in the absence of spondyloarthritis. Initial management should involve NSAIDs and a regular exercise program, while TNF and IL-17 inhibitors can be used for high disease activity unresponsive to these interventions. Goals of treatment include improving the frequent impairment of social and occupational function that occurs in nr-axSpA. CONCLUSIONS: We provide 22 evidence-based consensus statements to provide practical guidance in the assessment and management of nr-axSpA.
RESUMO
INTRODUCTION: The aim of this work is to perform a systematic review and meta-analysis of anti-tumor necrosis factor (anti-TNF) and anti-interleukin-17 (anti-IL-17) trials for spondyloarthritis, psoriatic arthritis, and psoriasis comparing rates of inflammatory bowel disease (IBD) events compared to placebo. METHODS: MEDLINE, EMBASE, and The Cochrane Library were searched for double-blind, randomized placebo-controlled anti-TNF and anti-IL-17 trials of included diseases. Inflammatory bowel disease events from the RCT period were pooled and meta-analyzed using statistical methods suitable for low-event-rate meta-analysis (Peto's, Mantel-Haenszel, hypergeometric-normal model, and Shuster-Guo-Skyler). When observed data were insufficient, we performed an exploratory sensitivity analysis to compare methods. RESULTS: We identified 9551 original papers, and included 96 publications: 65 anti-TNF and 31 anti-IL-17 trials, containing 21 new and 12 flare IBD events in 28,209 participants. New IBD on anti-IL-17 occurred 0.23/100 patient-years (PY) in psoriasis, 0.61/100 PY in PsA and 1.63/100 PY in spondyloarthritis, rates similar to observational cohorts, and less commonly on anti-TNF (0/100 PY, 0/100 PY, 0.32/100 PY, respectively). No evidence of difference between groups was found, with wide CI from many pooled counts of zero, especially in placebo arms. CONCLUSIONS: IBD events were rare, occurring at rates similar to biologic-naive groups. We could not find statistically significant differences in risk of new or recurrent IBD between treatment and control groups using selected meta-analytical methods for low event rate scenarios. Meta-analyses of this topic require more IBD events, ideally without pooling heterogeneous groups. Larger, thoroughly reported trials with systematic and detailed safety reporting are required to improve risk estimation and to make accurate inferences.
