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Johnson & Johnson release long-term data showing skin clearance, joint symptom relief, and safety of Tremfya (guselkumab)
Source: janssen.com
Tremfya (guselkumab)
Quote:
Johnson & Johnson today announced long-term data from the Phase 3 DISCOVER-2a study showing that the skin clearance, joint symptom relief, and safety of TREMFYA® (guselkumab) previously demonstrated through 24 weeks and one year (Week 52) in adults with active psoriatic arthritis (PsA) continued through two years (Week 112). These findings also confirmed that the robust efficacy TREMFYA demonstrated in patients at Week 24 on physical function, physical aspects of health-related quality of life, and resolution of enthesitis and dactylitis was also seen through Week 100. In addition, the extent of radiographic progression was studied through two years. These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, March 16–20, 2021.1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. to treat both adults with active PsA and adults with moderate to severe plaque psoriasis (PsO).
“PsA can be a chronically painful and debilitating disease, and many PsA patients are still searching for enduring relief of their symptoms,” said Philip J. Mease,e M.D., of the Swedish Medical Center/Providence St. Joseph Health and the University of Washington in Seattle, Washington and presenting author. “These data, which show that the observed benefits of TREMFYA in PsA continue through two years, represent positive news for physicians and patients alike.”
Results showed that at Week 100:
Complete Skin Clearance: In patients who had clinically meaningful skin involvement at baseline, 59 percent of those receiving TREMFYA every four weeks and 53 percent of those receiving TREMFYA every eight weeks achieved complete skin clearance (Psoriasis Area Severity Index [PASI] 100; utilizing non-responder imputation [NRI], with this method of analysis, subjects with missing data are assumed to be non-responders).
Joint Symptom Improvement: Among randomized patients, 76 percent of those receiving TREMFYA and 74 percent of those receiving TREMFYA achieved at least 20 percent improvement in the American College of Rheumatology (ACR 20) response criteria (utilizing NRI).
Radiographic Progression: At Week 24, TREMFYA demonstrated statistically significant inhibition of radiographic progression of joint structural damage (p=0.011) (as measured by PsA-modified van der Heijde-Sharp [vdH-S scores]). TREMFYA afforded numerically, but not statistically significant, less radiographic progression (p=0.072) compared with placebo. From Week 52-100, low rates of radiographic progression of joint damage were observed in patients receiving TREMFYA (0.75) and TREMFYA (0.46), which were both further numerically reduced from the results observed during Weeks 0-52 (1.06, 0.99,). In the group of patients who crossed over from placebo to TREMFYA at Week 24, mean changes in vdH-S scores were 1.12 from Week 0-24 while receiving placebo, and 0.34 from Week 24-52 and 0.13 from Week 52-100 while receiving TREMFYA, indicating that further numerical improvements were also made through Year Two in this group.
Durability: Robust joint and skin response rates and mean improvements from baseline in outcome measures were maintained through two years, and approximately 90 percent of patients randomized to TREMFYA continued treatment with TREMFYA through Week 100.
Safety: No new safety signals were observed in the safety analysis conducted through Week 112. TREMFYA safety in patients with active PsA through two years was comparable to safety at six months and one year and generally consistent with TREMFYA safety in patients with moderate to severe plaque PsO.
In addition, results showed 56 percent of TREMFYA patients and 55 percent of TREMFYA patients achieved at least 50 percent improvement in ACR score (utilizing NRI). Among patients who had clinically meaningful PsO at baseline, 62 percent of TREMFYA 4 week patients and 55 percent of TREMFYA 8 week patients achieved complete skin clearance as measured by the Investigator Global Assessment (IGA) score of 0 (utilizing NRI).
Source: janssen.com
Tremfya (guselkumab)
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