FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis - 19/02/25
, Jerry Bagel, MD b, Yu-Huei Huang, MD, PhD c, Andrew E. Pink, PhD d, Stephen K. Tyring, MD, PhD e, Georgios Kokolakis, MD, PhD f, Amy M. DeLozier, DrPH g, Shu Li, PhD h, Yaung-Kaung Shen, PhD h, Charles Iaconangelo, PhD h, Takayuki Ota, MD, PhD g, Robert Bissonnette, MD iAbstract |
Background |
More patients with moderate-to-severe plaque psoriasis achieved responses with JNJ-77242113, a targeted oral peptide inhibiting interleukin-23 receptor signaling, versus placebo (PBO) at week (W)16 of the phase 2 FRONTIER-1 study.
Objective |
FRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.
Methods |
FRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16–52. Safety follow-up continued through W56.
Results |
Most (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16–52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16–56, 59% of JNJ-77242113–treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.
Limitations |
The study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.
Conclusion |
Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.
Il testo completo di questo articolo è disponibile in PDF.Key words : IL-23, JNJ-77242113, long-term extension, oral, phase 2, plaque psoriasis
Abbreviations used : AE, COVID-19, GI, IGA, IL, LSM, LTE, MedDRA, MMRM, PASI, PBO, PsO, PSSD, SD, ss-IGA
Mappa
| Funding sources: This study was supported by Janssen Research and Development, LLC. |
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| JNJ-77242113 was jointly discovered by Protagonist and Janssen. The authors thank the patients, investigators, and trial personnel who made this phase 2 trial successful. Medical writing support was provided by Erica Chevalier-Larsen, PhD, of Janssen Scientific Affairs, LLC, under the direction of the authors and in accordance with Good Publication Practice guidelines (DeTora LM, et al. Ann Intern Med. 2022;175:1298-1304). |
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| Patient consent: Written informed consent was obtained from all patients. No recognizable patient photographs or other identifiable information is reported. |
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| IRB approval status: The protocol and all its amendments, informed consent forms, and recruiting materials were approved by the appropriate IRB. |
Vol 92 - N° 3
P. 495-502 - marzo 2025 Ritorno al numero
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