Background: We report long-term, end-of-study program safety outcomes from 25 randomized clinical trials (RCTs) in adult patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) [including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)] who received ≥ 1 dose of Ixekizumab (IXE) over 5 years (PsO) or up to 3 years (PsA, axSpA).
Methods: This integrated safety analysis consists of data from patients who received any dose of IXE, across 25 RCTs (17 PsO, 4 PsA, 4 axSpA). Rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and selected adverse events (AEs) of interest were analyzed for all pooled studies by years of therapy and overall, through March 2022.
Nonradiographic axial spondyloarthritis (nr-axSpA) represents a distinct phenotype within the spectrum of axial spondyloarthritis (axSpA), which is characterized by a range of clinical manifestations. Despite a high disease burden that is comparable to ankylosing spondylitis (also known as radiographic axSpA), there is an unmet need to recognize and effectively manage patients with active nr-axSpA.A targeted literature search was conducted in OVID (MEDLINE and Embase databases) to identify articles on nr-axSpA, including its definition, demographics, epidemiology, burden, diagnosis, clinical presentation, and treatment guidelines.
View Article and Find Full Text PDFIntroduction: Differences in psoriatic arthritis (PsA) treatment response between sexes for ixekizumab, an interleukin-17A antagonist, are largely unexplored. This analysis used data from randomized clinical trials (RCTs) evaluating ixekizumab to study differences in treatment response between male and female patients with PsA.
Methods: We used pooled data from patients enrolled in SPIRIT-P1 and SPIRIT-P2 (NCT01695239 and NCT02349295, respectively), phase 3 RCTs evaluating ixekizumab every 4 and 2 weeks in patients with active PsA.
Background: Intravenous (IV) golimumab, a TNFi, is approved for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). We analyzed pooled safety results from three phase 3 IV golimumab trials in these rheumatologic diseases and hypothesized that the safety profile of IV golimumab would be similar to that established for other TNFi, including subcutaneous golimumab.
Methods: Data from three double-blind, randomized trials of IV golimumab in patients with RA, PsA, and AS, each with a placebo-controlled period and an extension of active treatment, were included.
Sacroiliac (SI) joint subchondral resorption on high-resolution magnetic resonance imaging (MRI) may be an early sign of the development of sacroiliitis. At our institution, high-resolution intermediate-weighted (proton density) MRI sequences are used in the workup of suspected spondyloarthritis (SpA). : We sought to test the hypothesis that SI joint subchondral resorption might be a useful MRI feature in the diagnosis of sacroiliitis.
View Article and Find Full Text PDFTo critically appraise study designs evaluating spondyloarthritis (SpA) phenotypes in patients with inflammatory bowel disease (IBD). A systematic literature review of PubMed, Ovid, Scopus, Cinahl, Medline, Web of Science, and Cochrane databases was performed. Articles published from January 2000 - March 2020 were included if they evaluated the prevalence/incidence of musculoskeletal disease in cohorts of IBD patients.
View Article and Find Full Text PDFObjective: Frailty is associated with disability and mortality independent of age. Although studies have evaluated frailty in rheumatoid arthritis (RA), information on the prevalence of frailty in ankylosing spondylitis (AS) and psoriatic arthritis (PsA) is limited. We aimed to determine the prevalence of frailty in AS and PsA and to evaluate whether characteristics known to be associated with frailty, including anxiety, differ among these three types of inflammatory arthritis.
View Article and Find Full Text PDFAxial spondyloarthritis (axSpA) is a chronic, immune-mediated inflammatory disease characterized by inflammatory low back pain, inflammation in peripheral joints and entheses, and other extra-articular or systemic manifestations. Although our understanding of the natural history of axSpA has been limited by incomplete knowledge of disease pathogenesis, axSpA is increasingly understood as a spectrum of axial, peripheral, and extra-articular inflammatory conditions that includes nonradiographic axSpA and radiographic axSpA, also known as ankylosing spondylitis. In this narrative review, we present a road map of this axSpA continuum, highlighting genetic risk factors for the development of axSpA, triggers of disease, and reasons for and implications of diagnostic delay.
View Article and Find Full Text PDFObjective: Evaluate tolerability and effectiveness of golimumab-IV versus infliximab in patients with rheumatoid arthritis (RA) in a real-world setting.
Methods: AWARE, a prospective, real-world, pragmatic, observational, multicenter, phase 4 study, enrolled RA patients when initiating golimumab-IV or infliximab. Treatment decisions were made by the treating rheumatologist.
Objective: Prevalence of sacroiliitis in Crohn's disease (CD) is variable depending on defining criteria. This study utilized standardized sacroiliac joint (SIJ) magnetic resonance imaging (MRI) to identify sacroiliitis in CD patients and its association with clinical and serological markers.
Methods: Consecutive adult subjects with CD prospectively enrolled from an inflammatory bowel disease clinic underwent SIJ MRI.
Objective: To update guidance regarding the management of psoriatic disease during the COVID-19 pandemic.
Study Design: The task force (TF) includes 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation staff.
Objective: To provide guidance about management of psoriatic disease during the coronavirus disease 2019 (COVID-19) pandemic.
Study Design: A task force (TF) of 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care was convened. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation (NPF) staff.
Objectives: The aim of this integrated analysis is to evaluate the long-term safety and tolerability of ixekizumab in adults with psoriasis, PsA and axial SpA.
Methods: Integrated safety data from 21 clinical trials are presented by indication in patients who received at least one dose of ixekizumab. Adverse events (AEs) and treatment-emergent adverse events (TEAEs) adjusted incidence rates (IRs) per 100 patient-years (PY) up to 5 years' exposure are reported.
Objective: The development of biomarkers to guide treatment decisions is a major research focus in rheumatoid arthritis (RA). Patients with RA have elevated interleukin-6 (IL-6) levels; however, the utility of IL-6 as a predictor of treatment response is unclear. This study was undertaken to investigate, by post hoc analysis, whether baseline IL-6 levels are predictive of sarilumab treatment responses in 2 phase III studies.
View Article and Find Full Text PDFRheum Dis Clin North Am
August 2019
Hydroxychloroquine and quinacrine are frequently used to treat rheumatic diseases. Ocular toxicity, although infrequent, is one of the potential side effects of antimalarial therapies. Current recommendations are unifocal in being developed by only ophthalmologists who do not treat patients for their rheumatic diseases.
View Article and Find Full Text PDFPsoriasis is a chronic skin condition that is associated with several comorbidities and co-manifestations that reduce patient quality of life. Psoriatic arthritis (PsA) is a form of spondyloarthritis that is associated with psoriasis and typically involves peripheral disease, axial disease, enthesitis, dactylitis, and skin and nail lesions. Psoriatic arthritis is associated with a substantial psychosocial and functional burden and can lead to irreversible joint damage if left untreated.
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