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Johnson & Johnson today announced new Tremfya (guselkumab) efficacy and safety data from the Phase 3b Cosmos trial, evaluating this selective interleukin IL23 inhibitor in adults with active psoriatic arthritis (PsA)
Source: jnj.com
Tremfya (guselkumab)
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Johnson & Johnson today announced new TREMFYA® (guselkumab) efficacy and safety data from the Phase 3b COSMOS trial, evaluating this selective interleukin (IL)-23 inhibitor in adults with active psoriatic arthritis (PsA) who demonstrated inadequate efficacy or intolerance to tumor necrosis factor inhibition (TNFi). Results showed significantly higher proportions of patients treated with TREMFYA had improvement in joint signs and symptoms and complete skin clearance versus placebo at week 24 in this documented TNFi-IRa patient population, which is often more difficult to treat. Furthermore, improvements in signs and symptoms of PsA were maintained or numerically increased through one year (week 48) among TREMFYA-randomized patients.
“Active psoriatic arthritis is a heterogenous disease and a significant number of patients do not respond adequately to TNF inhibition,” said lead author Laura Coates, M.D., Ph.D., Associate Professor, University of Oxford, UK.b “The COSMOS data demonstrate that TREMFYA significantly improved signs and symptoms of active psoriatic arthritis across multiple clinical disease domains, including patient reported outcomes, with treatment effects observed by week four. These findings reinforce the utility of this alternative mechanism of action as a therapeutic option for adults with active psoriatic arthritis who have not responded to one or more therapies.”
Results show:
Joint Symptom Improvement:
44.4 percent (84/189) of patients who received TREMFYA versus 19.8 percent (19/96) of patients who received placebo achieved at least 20 percent improvement in the American College of Rheumatology criteria (ACR20) at week 24, the study’s primary endpoint. Results of the Early Escape (EE)-correction sensitivity analysisd indicated an ACR20 response rate of 48.1 percent (91/189) in the TREMFYA group. 54.9 percent of placebo patients who crossed over to TREMFYA at week 24 achieved ACR20 at week 48.
ACR20 response rates continued to improve across different analysis sets during the first year – 57.7 percent of TREMFYA patients at week 48 utilizing non-responder imputation [NRI] and >80 percent of week 24 responders maintained a response at week 48.
TREMFYA-treated patients had higher ACR20 and ACR50 response rates versus placebo as early as weeks four and eight, respectively.
At week 24, TREMFYA-treated patients had a greater least square (LS) mean change in Disease Activity in Psoriatic Arthritis (DAPSA)e score (-14.5 vs -5.7) and a higher DAPSA low disease activity (LDA) response rate (29.6 percent vs 13.5 percent) versus placebo, which increased over time to 44.4 percent at week 48.1 At week 24, the proportion of patients achieving DAPSA remission was numerically higher in the TREMFYA group versus placebo (5.3 percent vs 2.1 percent).
Among patients affected at baseline, numerically higher proportions of TREMFYA-treated patients than placebo patients had resolved enthesitisf (39.7 percent vs 18.8 percent) or dactylitisg (44.8 percent vs 25 percent) at week 24.
Improvements in Physical Function, Health-Related Quality of Life (HRQoL) and Fatigue:
At week 24, higher proportions of TREMFYA-treated patients versus placebo (37.5 percent vs 16.1 percent) achieved clinically meaningful improvements in physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]),h which increased to 53.4 percent at week 48.
TREMFYA-treated patients also reported better physical aspects of HRQoL (Short Form [SF]-36 Physical Component Summary [PCS] scores) versus placebo.
At week 24, higher proportions of TREMFYA-treated patients achieved a ≥4-point increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) versus placebo (42.9 percent vs 20.8 percent), reflecting a clinical meaningful improvement in fatigue.1,j This response was maintained and increased over time to 55.6 percent at week 48.
Complete Skin Clearance:
At week 24, the proportion of patients with ≥3 percent body surface area psoriatic involvement and an Investigator's Global Assessment (IGA)k score of ≥2 at baseline achieving complete skin clearance (100 percent improvement in Psoriasis Area Severity Index [PASI])l was significantly higher among those receiving TREMFYA than those receiving placebo (30.8 percent vs 3.8 percent).
At week 48, more than half of patients (53.4 percent) receiving TREMFYA (utilizing NRI) achieved complete skin clearance (PASI 100).
Consistent Safety Profile:
The TREMFYA treatment group demonstrated low rates of adverse events (AEs) leading to discontinuation and serious AEs (SAEs), which were comparable to that of the placebo group.
Through week 56, time-adjusted incidences of SAEs and AEs leading to treatment discontinuation, and serious infections were 6.3, 2.7, and 0.8 per 100 patient years, respectively.1 In the TREMFYA treatment group, one patient experienced a major adverse cardiovascular event at week 44; one malignancy occurred (prostatic adenocarcinoma); and two patients reported psychiatric disorders as SAEs.1 One case of suspected, but unconfirmed, inflammatory bowel disease was reported around one month after the patient discontinued TREMFYA due to an influenza-like illness.
Two TREMFYA-treated patients had a serious infection: one TREMFYA-randomized patient was hospitalized with community-acquired pneumonia diagnosed at week 12 (history of chronic obstructive pulmonary disease and heart disease) and the patient recovered with antibiotic treatment and resumed study agent. The second patient was hospitalized with acute pneumonia (week 48), who recovered following antibiotic therapy and continued TREMFYA.1 No opportunistic infections, cases of active TB, or deaths occurred.
These safety findings in TNFi-IR PsA patients through week 56 of COSMOS expand upon, and are consistent with, the accumulated TREMFYA safety profile established in psoriasis (PsO) patients receiving TREMFYA through five years (VOYAGE 1 and 2) and those seen in bio-naïve and TNFi-experienced PsA patients evaluated in DISCOVER-1 (one year) and DISCOVER-2 (two years).
“Results from this study provide further evidence that TREMFYA is effective in treating patients with various manifestations of active psoriatic arthritis even when TNF inhibitor treatment has failed,” said Soumya D. Chakravarty, M.D., Ph.D., Senior Director, Strategic Lead, Rheumatology Therapeutic Area, Janssen Scientific Affairs, LLC. “Active psoriatic arthritis is a chronic and often debilitating disease, so patients need treatment options with durable efficacy and an established safety profile. It is our goal to advance therapeutic options for people living with active psoriatic arthritis to enhance their chances to live life with reduced symptoms of active PsA.”
Source: jnj.com
Tremfya (guselkumab)