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Showing 79 results for “Clinical Trial”.

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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January 2023

Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00507-z

This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.

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December 2022

Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a Randomized Phase IIb Study of Abatacept in Psoriatic Arthritis

Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keac073

In this study abatacept 30/10 mg/kg and 10 mg/kg doses were associated with greater improvements from baseline in MRI detected synovitis and tenosynovitis, respectively, compared with placebo, confirming the clinical outcomes. Indeed, inflammatory components demonstrated the greatest change from baseline.

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Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases

Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00505-1

Salinas, et al. evaluate baricitinib safety with respect to VTE, MACE, and serious infection relative to TNFi in patients with RA, in routine care and observe an increased risk of VTE in patients taking baricitinib, compared to TNFi.

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October 2022

Comparative Performance of Composite Measures From Two Phase III Clinical Trials of Ixekizumab in Psoriatic Arthritis

RMD Open. 2022 doi: 10.1136/rmdopen-2022-002457

In this latest investigation into ixekizumab more patients achieved targets assessed by mCPDAI and DAPSA than with other composites. This study assess’ the concordance and variability in performance of the composite measures in patients with PsA, as well as to provide greater granularity to the frequency and severity of residual symptoms in patients who achieve treatment targets.

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