APEX 48-week topline findings
- 57% discount in radiographic development after placebo sufferers switched to Tremfya.
- Sustained ACR50 positive factors from week 24 to week 48 throughout each Q4W and Q8W dosing schedules.
- ~50% of change sufferers reached ACR50 by week 48.
- Sturdy joint enhancements maintained by 48 weeks.
- Security in line with Tremfya’s established profile; no new security indicators recognized.
Johnson & Johnson has shared new, long-term information from the Part IIIb APEX scientific trial (NCT04882098) evaluating Tremfya (guselkumab) in lively psoriatic arthritis (PsA).1
Lengthy-term information present sustained discount in PsA signs
Outcomes from the examine, introduced on the Inflammatory Pores and skin Illness Summit (ISDS) 2025, confirmed that Tremfya continued to cut back each indicators and signs of lively PsA and inhibit development of structural injury at 48 weeks.
Additional information introduced present:
- Placebo sufferers who switched to Tremfya at week 24 noticed radiographic development gradual by 57%, with imply PsA-modified van der Heijde-Sharp (vdH-S) rating change dropping from 0.96 (weeks 0-24) to 0.41 (weeks 24-48).
- Tremfya produced sustained will increase in American Faculty of Rheumatology response standards (ACR50) responses from week 24 to week 48 in each the every-4-week and every-8-week dosing teams.
- Practically half of placebo-treated sufferers who transitioned to Tremfya at week 24 achieved ACR50 by Week 48.
- Enhancements in joint outcomes have been sturdy by week 48 throughout dosing schedules.
- Security findings aligned with Tremfya’s established profile, with no new security indicators recognized.
In an organization press launch, Christopher Ritchlin, MD, MPH of the College of Rochester Medical Heart and APEX examine investigator, mentioned: “Psoriatic arthritis is a persistent situation the place joint injury can start early and progress rapidly if left untreated. The APEX examine outcomes present that guselkumab can inhibit this course of, even as soon as it has begun, making it a beneficial remedy possibility for each initiating remedy early and for sufferers who already present indicators of joint injury.”
Newest outcomes assist sBLA submission
Earlier in July, J&J
APEX outcomes from the time confirmed that the examine achieved its major consequence measure of decreasing joint signs (ACR20), in addition to its main secondary measure of inhibited development of structural injury as measured by change within the modified vdH-S rating at week 24, in comparison with placebo in bio-naïve sufferers.
In a press release from the sBLA announcement, Brandee Pappalardo, PhD, MPH, vice chairman, medical affairs, dermatology & rheumatology, Johnson & Johnson Modern Medication, mentioned: “Psoriatic arthritis is a fancy illness that may result in extreme and irreversible joint injury, which is why we’re devoted to creating revolutionary therapies that comprehensively tackle the long-term influence in addition to the on a regular basis challenges of this situation. With this new proof, Tremfya would change into the primary and solely IL-23 inhibitor confirmed to supply symptom management and to considerably inhibit the development of joint injury in sufferers dwelling with lively PsA.”
Earlier Tremfya findings reveal efficacy at 24 weeks
Extra
- By week 24, sufferers receiving Tremfya confirmed considerably much less radiographic development, with imply adjustments in modified vdH-S scores of 0.55 (Q4W) and 0.54 (Q8W), in comparison with 1.35 within the placebo group (p=0.002 and p<0.001, respectively).
- ACR20 responses have been achieved by 67% of sufferers within the Q4W group and 68% within the Q8W group, versus 47% within the placebo group (p<0.001).
- ACR50 response charges have been 41% for Q4W and 42% for Q8W dosing, in comparison with 20% for placebo.
APEX trial design
APEX is a multicenter, randomized, double-blind, placebo-controlled examine in biologic-naïve sufferers with lively PsA who had insufficient response to prior customary therapies.
- The trial begins with a 24-week double-blind, placebo-controlled remedy interval.
- That is adopted by a 24-week active-treatment part for all members.
- After remedy, sufferers full a 12-week security follow-up interval.
- Contributors who enter the long-term extension obtain a further 2 years of lively remedy earlier than a closing security follow-up.
References
1. New long-term information reinforces TREMFYA® (guselkumab) as the one IL-23 inhibitor confirmed to considerably inhibit structural joint injury in lively psoriatic arthritis. Information launch. Johnson & Johnson. November 17, 2025. Accessed November 17, 2025.
2. J&J Submits sBLA to FDA for Tremfya Label Growth Based mostly on PsA Joint Injury Inhibition Information. Utilized Medical Trials. July 29, 2025. Accessed November 17, 2025.
3. Part IIIb APEX Trial Finds Tremfya Considerably Slows Joint Injury Development in Psoriatic Arthritis. Utilized Medical Trials. June 11, 2025. Accessed November 17, 2025.
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