ORCID Profile
0000-0002-4155-9105
Current Organisation
University of Leeds
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Publisher: The Journal of Rheumatology
Date: 15-09-2018
Abstract: Recommendations regarding “treat to target” in psoriatic arthritis (PsA) have stated that the target should be remission or inactive disease. Potential definitions include very low disease activity (VLDA), PsA Disease Activity Score (PASDAS) near remission, Disease Activity Index for PsA (DAPSA) or clinical DAPSA (cDAPSA) remission. Our aim was to investigate the proportion of patients who fulfill these definitions and how much residual active disease remained. This analysis used 2 datasets: first, trial data from the Tight Control of PsA (TICOPA) study, which included 206 patients with recent-onset ( 2 yrs) PsA receiving standard and biological disease-modifying antirheumatic drugs (DMARD) and second, an observational clinical dataset from Italy of patients receiving biological DMARD. Proportions achieving each of the 4 potential targets were calculated in each dataset and comparisons between treatment groups were performed in the TICOPA dataset. Levels of residual disease were established for key clinical domains of PsA. All measures could differentiate the TICOPA trial treatment groups (p 0.03). Lower proportions of patients fulfilled the VLDA criteria compared to DAPSA or cDAPSA remission. PASDAS results were different between the cohorts. Residual active disease was low across all definitions although higher levels were seen in DAPSA and cDAPSA compared to VLDA, particularly for psoriasis. In all measures, the proportion with elevated C-reactive protein was similar and low. VLDA appears the most stringent measure. It ensures that significant active arthritis, enthesitis, and psoriasis are not present, in contrast with DAPSA and PASDAS, in which composite scores can “hide” active disease in some domains.
Publisher: Springer Science and Business Media LLC
Date: 05-09-2022
DOI: 10.1186/S13063-022-06589-Y
Abstract: Axial involvement constitutes a specific domain of psoriatic arthritis (PsA). Interleukin (IL)-23 inhibitors have demonstrated improvement in axial PsA (axPsA) symptoms, but have not shown efficacy in treating ankylosing spondylitis (AS), suggesting differences in axPsA processes and treatments. In a post hoc, pooled analysis of patients with investigator- and imaging-confirmed sacroiliitis in two phase 3, randomized, placebo-controlled studies (DISCOVER-1 and DISCOVER-2), patients treated with guselkumab, an IL-23p19 inhibitor, had greater axial symptom improvements compared with placebo. Confirmatory imaging at baseline was restricted to the sacroiliac (SI) joints, occurred prior to/at screening, and was locally read. The STAR study will prospectively assess efficacy outcomes in PsA patients with magnetic resonance imaging (MRI)-confirmed axial inflammation. Eligible, biologic-naïve patients with PsA ( N = 405) for ≥ 6 months and active disease (≥ 3 swollen and ≥ 3 tender joints, C-reactive protein [CRP] ≥ 0.3 mg/dL) despite prior non-biologic disease-modifying antirheumatic drugs, apremilast, and/or nonsteroidal anti-inflammatory drugs will be randomized (1:1:1) to guselkumab every 4 weeks (Q4W) guselkumab at week (W) 0, W4, then every 8 weeks (Q8W) or placebo with crossover to guselkumab at W24, W28, then Q8W. Patients will have Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4, spinal pain component score (0–10 visual analog scale) ≥ 4, and screening MRI-confirmed axial involvement (positive spine and/or SI joints according to centrally read Spondyloarthritis Research Consortium of Canada [SPARCC] score ≥ 3 in ≥ 1 region). The primary endpoint is mean change from baseline in BASDAI at W24 multiplicity controlled secondary endpoints at W24 include AS Disease Activity Score employing CRP (ASDAS), Disease Activity Index for PsA (DAPSA), Health Assessment Questionnaire – Disability Index (HAQ-DI), Investigator’s Global Assessment of skin disease (IGA), and mean changes from baseline in MRI SI joint SPARCC scores. Centrally read MRIs of spine and SI joints (scored using SPARCC) will be obtained at W0, W24, and W52, with readers blinded to treatment group and timepoint. Treatment group comparisons will be performed using a Cochran-Mantel-Haenszel or chi-square test for binary endpoints and analysis of covariance, mixed model for repeated measures, or constrained longitudinal data analysis for continuous endpoints. This study will evaluate the ability of guselkumab to reduce both axial symptoms and inflammation in patients with active PsA. This trial was registered at ClinicalTrials.gov, NCT04929210 , on 18 June 2021. Protocol version: Version 1.0 dated 14 April 2021.
Publisher: The Journal of Rheumatology
Date: 11-2020
Abstract: The Tight Control of inflammation in Psoriatic arthritis (TICOPA isrctn.com : ISRCTN30147736 ) trial compared standard care (StdC) and tight control (TC) in early psoriatic arthritis (PsA), demonstrating better outcomes for TC. This substudy evaluated the performance metrics of modern imaging outcomes and compared them to the clinical data. Non-contrast 0.2T magnetic resonance imaging (MRI single hand) was assessed using the Outcomes in Rheumatology (OMERACT) PsA MRI Scoring System (PsAMRIS) with an additional global inflammation score. Ultrasound (US same hand) was scored for greyscale, power Doppler, and erosions at the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints and scores summated. Seventy-eight patients had paired (baseline and 48 weeks) US data and 61 paired MRI data 50 had matched clinical, MR, and US data. Significant within-group changes were seen for the inflammatory PsAMRIS components at MCP level: MRI global inflammation [median difference (range), standardized response mean (SRM)]: 3.25 (−5.0 to 12.0), 0.68 1.0 (−4.5 to 17.5), 0.45 for TC and StdC, respectively. Similar within-group differences were obtained for US: 1.0 (−13.0 to 23.0), 0.45 3.0 (−6.0 to 21.0), 0.77 for TC and StdC, respectively. No differences were seen between treatment groups. Significant correlations were found between baseline and change MRI and US scores. A significant correlation was found between baseline PsA disease activity scores and MRI global inflammation scores (Spearman ρ for MCP, PIP: 0.46, 0.63, respectively). No differences in erosion progression were observed. The PsAMRIS and US inflammation scores demonstrated good responsiveness. No between-group differences were demonstrated, but this substudy was likely underpowered to determine differences between the 2 treatment strategies.
Publisher: BMJ
Date: 29-04-2022
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Philip Helliwell.