A systematic review and network meta-analysis of current and investigational treatments for active ankylosing spondylitis

Abstract

Objective To compare the relative efficacy of current and investigational biologic and oral small molecule (OSM) treatments for active ankylosing spondylitis (AS). Methods A systematic literature review was conducted to identify all phase 2/3 randomized trials of interest in patients with AS. Outcomes assessed were ≥ 20% improvement in the Assessment of Spondyloarthritis International Society Criteria (ASAS20) and change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) and C-reactive protein (CRP) at weeks 12-16. Bayesian network meta-analyses were conducted for outcomes using a random effects model. Baseline-risk adjustment was also conducted to account for differences in placebo response across studies. Surface Under the Cumulative Ranking curve (SUCRA) values are reported, reflecting the relative probability that intervention was the best of all interventions. Results The investigational agent tofacitinib 5 mg was the top-ranked treatment (SUCRA, 93%) for ASAS20 response, followed by intravenous (IV) golimumab 2 mg/kg (90%). Golimumab IV 2 mg/kg and infliximab 5 mg/kg were the top two ranked treatments for change from baseline in BASFI (golimumab IV, 81%; infliximab, 80%) and change from baseline in CRP (infliximab, 90%; golimumab IV, 82%). Conclusions Two approved therapies (golimumab IV, infliximab) and one investigational product ranked highest for efficacy in AS. Key Points • Although golimumab IV, infliximab, and tofacitinib ranked highest for efficacy in AS, differences in efficacy between approved and investigational therapies were not statistically significant.

Propensity score matching/reweighting analysis comparing intravenous golimumab to infliximab for ankylosing spondylitis using data from the GO-ALIVE and ASSERT trials

“…Several recent ITC studies have compared the effectiveness of biologic therapies in AS at time points varying from 6 to 24 weeks of treatment, and have generally concluded that no specific agent is superior to others [8,30,31,[35][36][37][38]. At the substantially longer treatment time points included in the present PSM study, GOL IV was found to be significantly more efficacious than IFX in terms of ASAS20 response.…”

“…Though MAIC is an acceptable approach, the absence of IPD from one of the trials necessitates the use of a broader IPD population compared with the comparator study. Weighting techniques are required to align patient populations, which may result in a smaller effective sample size [30]. In contrast, the PSM methods used in the present study use matching methods that are more intuitive to clinicians and decision makers compared with weighting methods.…”

“…In contrast with ASAS20 and BASFI, CRP is an objective parameter of inflammation. In addition, recent network meta-analyses (NMA) in AS have included CRP levels as an outcome of interest [30,31]. Although change in CRP levels was not originally reported in the GO-ALIVE study, access to IPD allowed for its inclusion in the present analysis.…”

Efficacy and safety of biologics for the treatment of ankylosing spondylitis: systematic literature review and network meta-analysis of treatments registered in the Russian Federation

“…В условиях отсутствия прямых сравнений основными источниками доказательств становятся сетевой метаанализ и непрямые сравнения. Вместе с тем, опубликованные в настоящее время систематические обзоры и метаанализы [13][14][15][16] не совсем релевантны для российской популяции пациентов, поскольку в них оценивались ГИБП или режимы их введения, не зарегистрированные в Российской Федерации (РФ). Кроме того, в них отсутствуют данные о препаратах, зарегистрированных и обращающихся только на территории России, к числу которых относится иИЛ-17 НТК.…”

Cervical spine fracture prediction by simple plain X-ray in ankylosing spondylitis patients after low-energy trauma

“…Even when a fracture is clinically suspected, the diagnosis can be di cult on the basis of X-ray alone, given the highly abnormal spinal structure in patients with AS, including ossi ed ligaments, surrounding osseous proliferation, poor outlining of the disc space, and osteoporosis [7,8]. Moreover, the diagnosis may be complicated by the presence of long-standing pain and the application of corticosteroid therapy and NSAIDs, which can mask the acute fracture symptoms [9]. In a study by Caron et al, 30% of the AS cases with spine fractures did not initially obtain correct diagnosis [10].…”