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Showing 83 results for “Clinical Trial”.

September 2023

Long-Term Safety and Efficacy of Ixekizumab in Patients with Axial Spondyloarthritis: 3-year Data from the COAST Program

J Rheumatol. 2023;50(8):1020–1028 doi: 10.3899/jrheum.221022

Three-year data from the ixekizumab (IXE) COAST programme provide additional evidence that patients with axSpA receiving IXE experience long-term safety, and sustained improvements in efficacy outcomes, at 3 years.

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The effect of ixekizumab on axial manifestations in patients with psoriatic arthritis from two phase III clinical trials: SPIRIT-P1 and SPIRIT-P2

Ther Adv Musculoskelet Dis. 2023;15:1759720X231189005 doi: 10.1177/1759720X231189005

Post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 concludes that ixekizumab (IXE) is effective in improving axial symptoms in patients with active PsA presenting with axial manifestations.

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July 2023

Pain and Inflammation as Mediators of Tofacitinib Treatment Effect on Fatigue in Patients with Ankylosing Spondylitis: A Mediation Analysis

Rheumatol Ther. 2023 doi 10.1007/s40744-023-00570-0 Epub ahead of print

Kristensen, et al. used mediation modelling to show that tofacitinib indirectly improved fatigue symptoms via back pain and morning stiffness. This study was carried out using FACIT-F- and BASDAI Q1-based models to determine the relationship between these variables.

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May 2023
March 2023

Association Between Baseline Cardiovascular Risk and Incidence Rates of Major Adverse Cardiovascular Events and Malignancies in Patients with Psoriatic Arthritis and Psoriasis Receiving Tofacitinib

Ther Adv Musculoskelet Dis. 2023 doi: 10.1177/1759720X221149965

Baseline 10-year atherosclerotic cardiovascular disease risk and metabolic syndrome are potentially associated with the incidence of both MACE and malignancies in patients receiving TOFA in the PsA and PsO clinical trial programs. This post hoc analysis aimed to examine the baseline CV disease risk and its association with the occurrence of MACE and malignancies in TOFA-treated patients with PsA and PsO.

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February 2023

The Effect of Guselkumab on Inhibiting Radiographic Progression in Patients with Active Psoriatic Arthritis: Study Protocol for APEX, a Phase 3b, Multicenter, Randomized, Double‑blind, Placebo‑controlled Trial

Trials. 2023 doi: 10.1186/s13063-022-06945-y

Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.

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Herpes zoster in Patients with Inflammatory Arthritides or Ulcerative Colitis Treated with Tofacitinib, Baricitinib or Upadacitinib: A Systematic Review of Clinical Trials and Real-world Studies

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

Overall, this evidence supports that HZ-risk is a “class” effect of JAKi, observing a higher risk compared to other non-biologic/biologic drugs . This study aimed to systematically review the incidence of HZ among RA, PsA, AS and UC patients treated with TOFA, BARI or UPA.

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Selective Inhibition of the MK2 Pathway: Data From a Phase IIa Randomized Clinical Trial in Rheumatoid Arthritis

ACR Open Rheumatol. 2023. doi: 10.1002/acr2.11517 Epub ahead of print

Data show that the first-in-class MK2 pathway inhibitor ATI-450 was well tolerated and induced sustained anti-inflammatory efficacy over 12 weeks in patients with moderate-to-severe RA.

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Impact of Cardiovascular Risk Enrichment on Incidence of Major Adverse Cardiovascular Events in the Tofacitinib Rheumatoid Arthritis Clinical Programme

Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-223406 Epub ahead of print

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

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