Rheumatology and Therapy

Summary of Research: Ten-Year Safety and Clinical Benefit from Open-Label Etanercept Treatment in Children and Young Adults with Juvenile Idiopathic Arthritis
Vojinović J, Foeldvari I, Dehoorne J, Panaviene V, Susic G, Horneff G, Stanevica V, Kobusinska K, Zuber Z, Dobrzyniecka B, Avcin T, Borlenghi C, Arthur E, Zang C, Tsekouras V, Vlahos B, Martini A, Ruperto N and
This is a summary of the original article 'Ten-year safety and clinical benefit from open label etanercept treatment in children and young adults with juvenile idiopathic arthritis'. Juvenile idiopathic arthritis (JIA) usually appears before the age of 16. JIA causes pain, swelling, and stiffness in the joints. People with JIA receive treatment for several years until the disease goes into prolonged remission. Therefore, the long-term safety of these treatments is an important topic. Etanercept is a treatment for JIA, which acts on the body's immune system to reduce arthritis. This summary of research article describes safety and how well etanercept works in children with JIA taking it for up to 10 years.
Fibro-adhesive Bursitis: A Novel Sonographic Finding in Adhesive Capsulitis Patients and a Proposal of Management
Vita F, Gualtierotti R, Miceli M, Tedeschi R, Origlio F, Cavallo M, Galletti S, Stella SM, Guerra E, Donati D and Faldini C
Adhesive capsulitis, also known as "frozen shoulder," is a debilitating shoulder condition increasingly linked to fibroadhesive bursitis, particularly after COVID-19 and related vaccinations. There is no definitive gold standard for its treatment, the primary therapeutic objectives of which are the reduction of pain and the restoration of shoulder range of motion. The aim of our study was to analyze treatment outcomes based on quantitative measures of shoulder function and symptom relief.
Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status
Ogdie A, Kristensen LE, Soriano ER, Akar S, Sun Y, Gruben D, Fallon L, Kinch CD and Gladman DD
Routine care studies of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) demonstrated attenuated responses to tumor necrosis factor inhibitors in current/past versus never smokers. This post hoc analysis assessed tofacitinib efficacy and safety in patients with PsA or AS by cigarette smoking status at trial screening.
Tofacitinib Safety and Effectiveness in Canadian Patients with Rheumatoid Arthritis by Cardiovascular Risk Enrichment: Subanalysis of the CANTORAL Study
Haraoui B, Khraishi M, Choquette D, Fortin I, Kinch CD, Galos C, Roy P, Gruben D, Vaillancourt J, Sampalis JS and Keystone EC
ORAL Surveillance, a post-authorisation safety study of patients with rheumatoid arthritis (RA) enriched for cardiovascular (CV) risk, demonstrated increased risk of major adverse CV events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) for tofacitinib versus tumour necrosis factor inhibitors (TNFi). This analysis of a real-world Canadian observational study evaluated tofacitinib safety/effectiveness in patients meeting or not meeting CV risk criteria.
Patient-Reported and Economic Racial and Ethnic Disparities in Patients with Psoriatic Arthritis: Results from the National Health and Wellness Survey
Lin I, Krupsky K, Way N, Patel AA and Tieng A
Psoriatic arthritis (PsA) is a chronic, autoimmune form of arthritis that is associated with a substantial humanistic and economic burden. Potential differences in patient-reported outcomes (PROs) and economic outcomes among groups of varying PsA severity and different races/ethnicities have not been well studied.
Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials
Mease P, Korotaeva T, Shesternya P, Kokhan M, Rukavitsyn A, Vasilchenkov D, Sharaf M, Lavie F and Deodhar A
There are limited data on the use of advanced therapies to treat psoriatic arthritis (PsA) in Russia. Guselkumab, an interleukin (IL)-23p19-subunit inhibitor, demonstrated efficacy in patients with PsA in the phase 3 DISCOVER-1 and -2, and COSMOS trials. This analysis evaluated the efficacy and safety of guselkumab in patients with PsA in Russia.
Does Concomitant Use of Methotrexate with JAK Inhibition Confer Benefit for Cardiovascular Outcomes? A Commentary
Taylor PC, Balsa A, Mongey AB, Filková M, Chebbah M, Le Clanche S, Verhagen LAW, Witte T, Opris-Belinski D, Marotte H and Avouac J
This commentary explores the potential cardiovascular (CV) benefits of combining methotrexate (MTX) and Janus kinase inhibitors (JAKis) in the treatment of rheumatoid arthritis (RA). While European guidelines recommend MTX as first-line treatment, concerns about the CV risks associated with JAKis have emerged. This article reviews the existing literature to assess the role of concomitant MTX in reducing CV risk when used with JAKis. Clinical trials confirm the efficacy of JAKis in combination with MTX in terms of treatment outcomes in RA. However, the number of major adverse cardiovascular events (MACEs) reported is too low to draw conclusions on adverse CV outcomes. Indirect evidence does, however, suggest potential protective effects of MTX on CV outcomes, as several mechanisms may contribute to MTX's cardioprotective effects, including reduced inflammation, adenosine monophosphate-activated protein kinase (AMPK) activation, increased cholesterol efflux, and adenosine accumulation. These mechanisms and the available data may support the case for CV benefits of concomitant MTX when JAKis are used in the treatment of patients with RA, although further research is needed. In particular, the lipid paradox associated with RA highlights the complex relationship between RA treatments (MTX, JAKis, tumor necrosis factor (TNF) inhibitors, and interleukin (IL)-6 receptor inhibitors), inflammation, different lipid profiles, and CV risk. In the absence of contraindications and when MTX is tolerated, this commentary suggests the concomitant use of MTX and JAKis as a preferred option for optimizing CV protection in patients with RA.
The Development and Content Validation of the Sjögren's Related Quality of Life Instrument (SRQoL)
Marvel J, Gargon E, Howse C, Chohan A, Mayhew M, Kenney G, Stone L, Fisher BA, Steenackers M, Williamson N, Perella C and Goswami P
Several clinical outcome assessment (COA) instruments assess Sjögren's disease (Sjögren's) symptoms, but do not provide comprehensive assessment of the health-related quality of life (HRQoL) impact of Sjögren's. This study aimed to develop a patient-reported outcome (PRO) instrument for the assessment of HRQoL, intended for use in clinical trials and clinical practice in the assessment of treatment benefit.
How Are We Addressing Axial Psoriatic Arthritis in Clinical Practice?
Michelena X, López-Medina C, De Miguel E, Moreno-Ramos MJ, Queiro R, Marzo-Ortega H and Juanola X
Psoriatic arthritis (PsA) is a chronic inflammatory disease affecting the musculoskeletal system, skin and nails. In addition to peripheral joints, inflammation of the spine and sacroiliac joints may occur. Yet, research into this axial phenotype has lagged behind partly because of the challenge in its clinical identification with a lack of specific clinical, molecular or imaging biomarkers. In the absence of a validated definition of what constitutes axial PsA (axPsA), guidelines for the management of axial involvement in PsA in clinical practice are scarce. On the basis of a literature review and their clinical expertise, a group of rheumatology experts provide their opinion to aid the diagnosis and management of axial PsA in clinical practice.
Disease Overlap, Healthcare Resource Utilization, and Costs in Patients with Eosinophilic Granulomatosis with Polyangiitis: A REVEAL Sub-study
Xu X, Edmonds C, Kim Y, Stokes M, Stirnadel-Farrant HA, Kwiatek J and Katial R
Eosinophilic granulomatosis with polyangiitis (EGPA) is an eosinophil-associated disease (EAD) characterized by inflammation in small- to medium-sized blood vessels. In the REal-world inVestigation of Eosinophilic-Associated disease overLap (REVEAL) study, overlap among 11 EADs was assessed. In the present sub-study, we evaluated EGPA overlap with other EADs, all-cause EAD- and EGPA-related healthcare resource utilization (HCRU) and costs, and their relationship with blood eosinophil count and treatments received.
Literature Review to Understand the Burden and Current Non-surgical Management of Moderate-Severe Pain Associated with Knee Osteoarthritis
Castro-Dominguez F, Tibesku C, McAlindon T, Freitas R, Ivanavicius S, Kandaswamy P, Sears A and Latourte A
To conduct a literature review exploring the humanistic burden, costs, and guideline recommendations for non-surgical management of moderate-severe pain in knee osteoarthritis (KOA).
Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials
Curtis JR, Deodhar A, Soriano ER, Rampakakis E, Shawi M, Shiff NJ, Han C, Tillett W and Gladman DD
Patterns of treatment response can inform clinical decision-making. This study assessed the course and impact of achieving minimal clinically important improvement (MCII) in clinical measures and patient-reported outcomes (PROs) with guselkumab in patients with active psoriatic arthritis (PsA).
Real-world Effectiveness of Sarilumab in RA: Results from the Open-label, Prospective, Single-arm Observational PROFILE Study
Kivitz A, Gottenberg JE, Bergman M, Qiu C, van Hoogstraten H, de Nijs R and Bessette L
The 1-year PROspective sarilumab (preFILled syringe/pen) multinational, obsErvational (PROFILE) study evaluated the real-world effectiveness and safety of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA).
Characteristics and Management of Uncontrolled Gout Prior to Pegloticase Therapy: A 2-year Claims Analysis
Morlock RJ, Dalal D, Divino V, DeKoven M, Taylor SD, Powers A, Barretto N, Holt RJ and LaMoreaux B
Gout is a progressive form of arthritis that causes significant pain and disability. Patients with treatment-refractory (or uncontrolled) gout experience a higher prevalence and severity of comorbidities than those whose gout is controlled. Pegloticase is a recombinant PEGylated uricase indicated for the treatment of gout in patients refractory to conventional therapy. We evaluated the treatment journey of patients with chronic uncontrolled gout before initiation of pegloticase therapy.
Summary of Research: Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA
Strand V
This Summary of Research overviews the results of a study that looked at patient-reported outcomes in the VOLTAIRE-RA trial (NCT02137226), originally published in Rheumatology and Therapy. A biosimilar is a biologic medicine made to be very similar to the original biologic medicine (also known as the reference product). The VOLTAIRE-RA trial compared the efficacy and safety of an adalimumab biosimilar (Cyltezo, adalimumab-admb) with the adalimumab reference product, Humira, in people with rheumatoid arthritis. As part of the VOLTAIRE-RA study, participants took either adalimumab-adbm or adalimumab reference product for 24 weeks. Patient-reported outcomes were captured after 12 weeks and after 24 weeks of treatment to assess the effects of treatment on each participant's health-related quality of life. People with rheumatoid arthritis who were given adalimumab-adbm or adalimumab reference product experienced similar clinically meaningful improvements in their health-related quality of life after 12 weeks of treatment. A high proportion of people in this trial who were given adalimumab-adbm or adalimumab reference product reported greater improvement versus a reference US population matched by age and sex. This is notable, as it represents a treatment goal that was difficult to achieve in earlier rheumatoid arthritis trials of non-biologic treatments.
Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J and McInnes IB
The relative efficacy of bimekizumab and risankizumab in patients with PsA who were biologic disease-modifying anti-rheumatic drug naïve (bDMARD naïve) or with previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR) was assessed at 52 weeks (Wk52) using matching-adjusted indirect comparisons (MAIC).
Treatment with Targeted Therapy in Patients with Psoriatic Arthritis and Inadequate Response to Methotrexate: Proposal for a Rational Strategy
Goupille P, Carvajal Alegria G, Verhoeven F and Wendling D
The therapeutic arsenal for psoriatic arthritis (PsA) is gradually being expanded, but the use of these targeted treatments must be optimal. Our objective was to guide the choice of targeted therapy to use as first-line treatment in a patient with PsA in whom methotrexate (MTX) has failed.
The Challenge of IBD-Related Arthritis Screening Questionnaires in Early and Predominantly Entheseal Phenotypes
Zabotti A, Cabas N, Cacioppo S, Zoratti C, Giovannini I, Berretti D, Luchetti MM, De Vita S, Quartuccio L, Terrosu G and Marino M
Inflammatory bowel disease (IBD)-related arthritis is recognized as the most prevalent extraintestinal manifestation (EIM) of IBD. The objective of this study was to determine the prevalence and characteristics of undiagnosed IBD-related arthritis and to compare two screening questionnaires, DETection of Arthritis in Inflammatory boweL diseases (DETAIL) and IBd Identification of Spondyloarthritis Questionnaire (IBIS-q), for early disease detection.
Ixekizumab Treatment Patterns and Health Care Resource Utilization Among Patients with Axial Spondyloarthritis: A Retrospective United States Claims Database Study
Danve A, Vadhariya A, Lisse J, Cholayil A, Bansal N, Bello N and Bakewell C
Real-world data on ixekizumab utilization in axial spondyloarthritis (axSpA) are limited. We evaluated ixekizumab treatment patterns and health care resource utilization (HCRU) in patients with axSpA using United States Merative L.P. MarketScan Claims Databases.
Clinical and Ultrasonographic Remission in Bio-naïve and Bio-failure Patients with Rheumatoid Arthritis at 24 Weeks of Upadacitinib Treatment: The UPARAREMUS Real-Life Study
Picchianti Diamanti A, Cattaruzza MS, Salemi S, Di Rosa R, Sesti G, De Lorenzo C, Felice GM, Frediani B, Baldi C, Chimenti MS, D'Antonio A, Crepaldi G, Luchetti MM, Paci V, Zabotti A, Giovannini I, Canzoni M, Sebastiani G, Scirocco C, Perricone C, Laganà B and Iagnocco A
Clinical remission is the main target in the management of patients with rheumatoid arthritis (RA). However, several authors found synovitis in patients with RA in clinical remission at ultrasonography (US). Upadacitinib is a selective Janus kinase 1 inhibitor that achieved significantly higher remission rates than adalimumab and abatacept in patients with RA. Here we present the 24-week data of the UPAdacitinib Rheumatoid Arthritis REmission UltraSonography (UPARAREMUS) study.
Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies
Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewé RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J and Coates LC
Psoriatic arthritis (PsA) is a chronic inflammatory disease requiring long-term treatment. Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated tolerability and sustained clinical efficacy for up to 1 year for patients with PsA. Here, we report the longer-‍term safety and efficacy of bimekizumab up to 2 years.