Guselkumab

Johnson & Johnson (J&J) has announced new data showing that Tremfya (guselkumab) reduces symptoms of psoriatic arthritis (PsA) and also inhibits structural joint damage associated with the condition. Tremfya is a dual-acting monoclonal antibody that works by blocking IL-23, a cytokine known to drive immune-related conditions. Tremfya also binds to CD64, a receptor that produce IL-23. It is the only drug of its kind approved to treat PsA. J&J’s phase 3 APEX study showed that Tremfya continued to inhibit joint damage up to and throughout week 48 of the study. Participants also showed a clinically meaningful improvement in the American College of Rheumatology’s response criteria rates, which measure tenderness and swelling in affected joints. No new safety signals associated with Tremfya were demonstrated in the study, in line with the drug’s well-established safety profile. J&J recently submitted a Biologics License Application to the US FDA for approval to edit the Tremfya label, adding new evidence for its capacity to inhibit the progression of joint damage. “This long-term data show that Tremfya has set a new benchmark as the only IL-23 inhibitor proven to inhibit structural damage in active psoriatic arthritis, which can develop in up to 30% of people living with psoriasis,” said Leonard Dragone, vice president, rheumatology and autoantibody disease area leader, Johnson & Johnson Innovative Medicine. PsA is a long-term inflammatory arthritis condition characterised by symptoms such as pain, swelling and stiffness in the joints, as well as fatigue and possible flare-ups of psoriasis-related skin symptoms. The condition can be severely disabling, and early intervention is important for the prevention of joint damage. Christopher Ritchlin, an investigator in the APEX study, said: “Psoriatic arthritis is a chronic condition where joint damage can begin early and progress quickly if left untreated. The APEX study results show that guselkumab can inhibit this process, even once it has begun, making it a valuable treatment option for both initiating treatment early and for patients who already show signs of joint damage.”

THURSDAY, Nov. 20, 2025 — New guidelines recommend doctors tackle Crohn’s disease head-on, calling for the use of cutting-edge drugs as early as possible to quell the autoimmune GI disorder as quickly as possible. The updated American Gastroenterological Association guidelines reject a “ step-up ” approach in which people get more advanced drugs only after they’ve tried cheaper, less effective medications like steroids or immunomodulating drugs like thiopurines . Instead, doctors should go straight to monoclonal antibody drugs that target different factors that promote Crohn’s disease, according to 2025 guidelines published in the journal Gastroenterology . “The science in Crohn’s disease is moving quickly, and our goal was to translate that evidence into clear, meaningful recommendations for front-line clinicians,” guideline author Dr. Siddharth Singh , a gastroenterologist with the Mayo Clinic in Phoenix, Arizona, said in a news release. Insurance companies encourage the step-up approach as a means of limiting costs, the AGA says. Patients are required to try less effective but cheaper drugs before insurers will agree to cover more advanced medications. “We didn’t write this guideline to follow insurance rules,” Singh said. “Insurance coverage should follow the evidence.” Crohn’s disease occurs when the immune system causes damaging inflammation in a person’s digestive tract, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The most common symptoms are diarrhea, abdominal pain and weight loss, but if left untreated Crohn’s disease can lead to anemia, bone loss, malnutrition and colon cancer, the NIDDK says. In its new guideline, the AGA recommends infliximab , adalimumab , ustekinumab , risankizumab , mirikizumab , guselkumab or upadacitinib as first-line treatments for moderate-to-severe Crohn’s disease. Most of these drugs are monoclonal antibody therapies that target different biological factors that drive the inflammation associated with Crohn’s, experts said. The guidelines also recommmend a small-molecule drug called upadacitinib, which helps by inhibiting an enzyme that promotes inflammation. Other suggested drugs include certolizumab pegol and vedolizumab . The guideline specifically suggests against using the class of immune-modulating drugs known as thiopurines to make Crohn’s symptoms go away. However, thiopurines can be used to keep Crohn’s at bay in patients who’ve gone into remission using steroid drugs, the guideline says. “These recommendations are about helping patients and providers make informed choices,” Singh said. “Our goal is to empower shared decision-making and ensure these evidence-based options are accessible and covered by insurance.” “Patients should recognize that there are now multiple treatment options available to them, regardless of where they are in their treatment journey,” Dr. Frank Scott , chair of the guideline panel, said in a news release. “These guidelines highlight those options — and they call for payors to align their formularies with evidence-based medicine.” Sources American Gastroenterological Association, news release, Nov. 20, 2025 Gastroenterology, December 2025