Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials
ConclusionHigher rates of serious infection, HZ, lymphopenia, and NMSC were observed with upadacitinib versus adalimumab in PsA; slightly elevated rates for most of these TEAEs were seen with upadacitinib in PsA versus axSpA. Upadacitinib 15 mg demonstrated a generally consistent safety profile across disease states with no new safety signals identified.Trial RegistrationSELECT-AXIS 1: NCT03178487; SELECT-AXIS 2: NCT04169373; SELECT-PsA 1: NCT03104400; SELECT-PsA 2: NCT03104374. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 29, 2024 Category: Rheumatology Source Type: research
A Phase 1a Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7303509, an Anti-TGF β3 Antibody, in Healthy Volunteers
ConclusionRO7303509 was well tolerated at single SC doses up to 1200 mg in HVs with favorable pharmacokinetic data that appeared to increase dose-proportionally. TGFβ3-specific inhibition may be suitable for development as a chronic antifibrotic therapy.Trial RegistrationISRCTN13175485. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 25, 2024 Category: Rheumatology Source Type: research
Elevating the Standard of Care for Patients with Axial Spondyloarthritis: ‘Calls to Action’ from Rheumacensus, a Multistakeholder Pan-European Initiative
ConclusionRheumacensus identified CTA to help bridge the disparities observed in axSpA care. It is now imperative for all stakeholders to take practical steps towards addressing these CTA to elevate the SoC and treatment ambition in patients with axSpA. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 25, 2024 Category: Rheumatology Source Type: research
Population Pharmacokinetics of the Anti-Interferon-Gamma Monoclonal Antibody Emapalumab: An Updated Analysis
ConclusionsEmapalumab pharmacokinetics in patients with primary HLH and MAS in sJIA were described by a two-compartment model with fixed allometric exponents and an age-related effect. Differences in total IFN γ levels between patients with primary HLH and MAS may affect emapalumab pharmacokinetics, suggesting that each indication may require different dosing to rapidly control hyperinflammation.Trial registrationClinicaltrials.gov identifiers: NCT01818492, NCT03311854 and NCT02069899. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 25, 2024 Category: Rheumatology Source Type: research
Elevating the Standard of Care for Patients with Psoriatic Arthritis: ‘Calls to Action’ from a Multistakeholder Pan-European Initiative
ConclusionRheumacensus has identified shortcomings in the current SoC for patients with PsA and provides a foundation for change through practical CTA. It is hoped that all stakeholders will now take practical steps towards implementing these CTA across Europe to elevate the SoC for patients with PsA. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 25, 2024 Category: Rheumatology Source Type: research
A Machine Learning Approach for Prediction of CDAI Remission with TNF Inhibitors: A Concept of Precision Medicine from the FIRST Registry
ConclusionsWhile external cohort validation is warranted for broader applicability, this study highlights the potential for a low-cost predictive model to predict CDAI remission following TNFi treatment. The approach of the study using only baseline data and 6-month CDAI measures, suggests the feasibility of establishing regional cohorts to generate low-cost models tailored to specific regions or institutions. This may facilitate the application of regional/in-house precision medicine strategies in RA management. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 18, 2024 Category: Rheumatology Source Type: research
Exploring the Effects of Ixekizumab on Pain in Patients with Ankylosing Spondylitis Based on Objective Measures of Inflammation: Post Hoc Analysis from a Large Randomized Clinical Trial
ConclusionThis post hoc analysis is supportive of the hypothesis that ixekizumab reduces pain in AS by additional mechanisms other than the reduction of measurable inflammation.Trial Registration NumberNCT02696785. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 18, 2024 Category: Rheumatology Source Type: research
Efficacy and Safety of Secukinumab in US Patients with Psoriatic Arthritis: A Subgroup Analysis of the Phase 3 FUTURE Studies
ConclusionsIn this challenging sub-population of US patients with PsA, secukinumab provided rapid improvements in disease activity and QoL. Patients with PsA and active psoriasis might benefit more from secukinumab 300 mg than 150 mg. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 16, 2024 Category: Rheumatology Source Type: research
Clinical Characteristics of “Severe” Peripheral Psoriatic Arthritis: A Retrospective Analysis of a Longitudinal Cohort
ConclusionsOur study showed that severe patients with PsA had more disease activity, pain, and impact of disease than non-severe patients. Furthermore, we demonstrated that severity and disease activity are not interchangeable concepts. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 9, 2024 Category: Rheumatology Source Type: research
Current Use and Barriers to Point-of-Care Ultrasound in Rheumatology: A National Survey of VA Medical Centers
ConclusionCurrently, half of rheumatology groups use diagnostic and procedural ultrasound applications. Most rheumatology groups desire training, and lack of training and equipment were the most common barriers to ultrasound use. Deliberate investment is needed in ultrasound training and infrastructure for systematic adoption of POCUS in rheumatology.Graphical Abstract available for this article.Trial RegistrationNCT03296280.Graphical Abstract (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 6, 2024 Category: Rheumatology Source Type: research
Characteristics and 6-Month Outcomes in Patients with Rheumatoid Arthritis Initiating Infliximab Biosimilar IFX-dyyb in a Real-World Setting
ConclusionIn this real-world population of patients with RA initiating IFX-dyyb, the majority switched from IFX-REF or a non-IFX biologic/tsDMARD. CDAI remained stable in patients switching from IFX-REF/IFX biosimilar and improved in patients switching from a non-IFX biologic/tsDMARD and in biologic/tsDMARD-na ïve patients. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 20, 2024 Category: Rheumatology Source Type: research
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial
ConclusionsRisankizumab demonstrated durable efficacy and tolerability through 100 weeks; most patients who achieved ACR20 and MDA responses at week 52 maintained this achievement through week 100. There were no new safety signals in patients who had csDMARD-IR and bDMARD-IR.Trial RegistrationClinicalTrials.gov NCT03671148. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 18, 2024 Category: Rheumatology Source Type: research
Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany
ConclusionCM-chitosan showed a rapid onset of pain relief after 1 week and with a duration of 9 months. In a real-world setting, treatment with CM-chitosan would appear to be a potentially effective option to reduce pain and improve physical function and global condition in patients with knee OA, opening new perspectives in patients who are considered as refrac tory to current symptomatic therapies and where the unmet need is high.Trial Registration NumberNCT04757051 (ClinicalTrials.gov). (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 18, 2024 Category: Rheumatology Source Type: research
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial
ConclusionsFor patients with active PsA who are csDMARD-IR, risankizumab demonstrated durable long-term efficacy and was generally well tolerated, with a consistent long-term safety profile.Trial RegistrationClinicalTrials.gov identifier, NCT03675308. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 18, 2024 Category: Rheumatology Source Type: research
Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison
ConclusionsAccording to MAICs, bimekizumab demonstrated greater or comparable efficacy on ACR50/70 and MDA outcomes than guselkumab in patients with PsA who were bDMARD-na ïve and TNFi-IR at week 48/52. Bimekizumab had a more favorable likelihood than guselkumab in achieving more stringent treatment outcomes.Trial RegistrationsNCT03895203, NCT03896581, NCT04009499, NCT03158285, NCT03796858. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 15, 2024 Category: Rheumatology Source Type: research
