November 08, 2023
Tremfya (Guselkumab) Shines in Real-World Settings: Unveiling Significant Improvements in Patient-Reported Outcomes for Active Psoriatic Arthritis
Janssen Pharmaceuticals recently unveiled data derived from real-world scenarios, illuminating substantial improvements in patient-reported outcomes for those grappling with active psoriatic arthritis (PsA) undergoing treatment with Tremfya (guselkumab). These insights, extracted from the CorEvitas Psoriatic Arthritis and Spondyloarthritis Registry, underscored significant enhancements in pain relief, improved physical function, and reduced fatigue over a six-month period in individuals dealing with treatment-resistant active PsA.
Beyond the real-world observations, a thorough examination covering three pivotal clinical trials—DISCOVER-1, DISCOVER-2, and COSMOS—revealed that Tremfya treatment led to heightened rates of meaningful clinical improvements across multiple facets. This composite assessment considered patient-reported pain, fatigue, physical function, skin conditions, and PsA-related depression, using the PsA 5-Thermometer Scale Domains (PsA-5T-Ds) during the initial evaluation.
Tremfya, distinguished as the premier fully human selective interleukin (IL)-23p19-subunit inhibitor therapy sanctioned for active PsA in adults, has demonstrated efficacy across diverse PsA domains, solidifying its position as a promising therapeutic avenue for individuals dealing with treatment-resistant active disease.
An in-depth analysis of CorEvitas registry data uncovered noteworthy improvements in key aspects among individuals persisting with Tremfya treatment:
PsA-Related Pain Reduction: Participants grappling with moderate PsA-related pain before commencing Tremfya reported significant reductions, with a substantial proportion experiencing clinically meaningful improvements. 30% of patients treated with Tremfya had ≥30 percent reduction and 40% reported ≥15-mm reduction.
Joint and Skin Disease Improvement: Assessment of overall joint and skin disease indicated that a significant percentage of participants achieved clinically meaningful improvements.
Enhanced Physical Function: Participants evaluated for physical function exhibited substantial improvements, experiencing clinically meaningful enhancements.
Fatigue Reduction: The mean change in PsA-related fatigue from baseline at six months demonstrated a significant reduction, providing substantial relief.
These findings hold particular significance as they address the formidable challenges associated with psoriatic arthritis, significantly influencing the health-related quality of life for individuals navigating the complexities of PsA. Moreover, the scrutiny of clinical trial data substantiates the entrenched efficacy of Tremfya across pivotal patient-reported outcomes for PsA.
November 07, 2023
TAK-279, Takeda's TYK2 Inhibitor, Demonstrates Positive Efficacy in Patients with Active Psoriatic Arthritis
Takeda announced the Phase 2b study of oral TYK2 inhibitor, TAK-279 in patients with active psoriatic arthritis.
The trial successfully achieved its primary endpoint, with 53.3% (15 mg) and 54.2% (30 mg) of patients treated with TAK-279 attaining at least an American College of Rheumatology 20 (ACR 20) response, surpassing the 29.2% in the placebo group by week 12.
Takeda is set to launch Phase 3 studies for plaque psoriasis in FY23 and psoriatic arthritis in FY24. Additionally, explorations for TAK-279 are underway in systemic lupus erythematosus, inflammatory bowel disease, and other indications.
In the study, TAK-279 showcased significant advancements in various aspects:
ACR 50 Response: 26.7% (15 mg) and 26.4% (30 mg) achieved ACR 50 response, in contrast to 9.7% in the placebo group.
ACR 70 Response: A greater percentage of individuals administered TAK-279 at 15 mg (14.7%) and 30 mg (13.9%) achieved an ACR 70 response in contrast to those receiving the placebo (5.6%).
PASI 75 in Patients with BSA ≥3% at Baseline: A greater percentage of patients treated with TAK-279 (45.7% [30 mg], 28.3% [15 mg], and 25.6% [5 mg]) achieved PASI 75 compared to placebo (15.4%).
Joint Count Reduction: Decreases in the mean change from the baseline were noted in both tender joint count and swollen joint count, demonstrating more substantial reductions in the 15 mg and 30 mg dosages.
MDA Response Rates: Higher MDA response rates were recorded in TAK-279 15 mg and 30 mg groups compared to placebo.
The most common treatment-emergent adverse events (TEAEs) included nasopharyngitis, upper respiratory tract infections, headache, and rash.
November 07, 2023
Amgen's Otezla Demonstrates Significant Efficacy in Early Oligoarticular Psoriatic Arthritis in Phase 4 FOREMOST Study
Amgen has presented efficacy data regarding Otezla in patients diagnosed with early oligoarticular psoriatic arthritis. This revelation stemmed from the Phase 4 FOREMOST study, where the effectiveness of Otezla (apremilast) was showcased in individuals grappling with early oligoarticular psoriatic arthritis.
The Phase 4 FOREMOST trial is a Phase IV placebo-controlled study specifically designed for patients dealing with early oligoarticular psoriatic arthritis.
The primary endpoint of the research was the modified minimal disease activity (MDA-joints), indicating that 33.9% of patients treated with Otezla successfully met the endpoint, as opposed to 16.0% of patients on placebo.
MDA-Joints is a comprehensive assessment method that involves a tender joint count of one or less and a swollen joint count of one or less. Additionally, patients must achieve at least three of the following criteria to meet this standard:
Psoriasis Body Surface Area (BSA) of three percent or lower, patient-assessed pain rating using a 100-mm visual analogue scale of 15 or less
Patient Global Assessment (PtGA) of disease activity using a 100-mm scale of 20 or less
Health Assessment Questionnaire-Disability Index (HAQ-DI) score indicating the physical function of 0.5 or less
Enthesitis count of one or less according to the Leeds Enthesitis Index.
Furthermore, in terms of Clinical Disease Activity in psoriatic arthritis (cDAPSA) remission, the study showed that 70.2% of patients treated with Otezla reached the endpoint, while 51.8% of patients on placebo achieved the same level of remission.