Janssen has announced that the U.S Food and Drug Administration has approved Tremfya (guselkumab) for treating adult patients with psoriatic arthritis. The drug can be administered as monotherapy or in combination with disease-modifying anti-rheumatic drugs (like methotrexate).
The approval is based on two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which evaluated the safety and efficacy of Tremfya versus placebo. DISCOVER-1 study enrolled patients who were previously treated with two anti-tumor necrosis factor agents, whereas DISCOVER-2 trial enrolled treatment naïve patients. Methotrexate is co-administered in fifty-eight patients in both the trials.
In DISCOVER-1 trial, 59% of patients who were on every four weeks treatment with Tremfya had a 20% improvement in ACR response (ACRO20), 52% of patients who were on treatment with Tremfya every eight weeks had improvement in ACR20. 22% of patients who were on placebo achieved ACR20 response. 37% of patients who were administered with Tremfya every four weeks achieved ACR50, 30% of patients who were administered with Tremfya every eight weeks achieved ACR50. Only 9% of patients who were on placebo achieved ACR50.
In the DISCOVER-2 trial, 64% of the patients who were on Tremfya had improvement in ACR20 response compared to 33% of patients who were on placebo. 33% of patients who were administered with Tremfya every four weeks achieved ACR50, 31% of patients who were administered with Tremfya every eight weeks achieved ACR50 at week 24. Only 9% of patients who were on placebo achieved ACR50.
Tremfya was administered as a 100 mg subcutaneous injection on weeks 0 and 4, and then every eight weeks after that.
Tremfya is a selective interleukin-23 inhibitor. It is the first IL-23 inhibitor approved for psoriatic arthritis. The product has been prior approved for psoriasis in the U.S., Canada, European Union, Japan, and other countries. The product has been approved in Japan and Brazil for psoriatic arthritis in addition to the U.S.
About psoriatic arthritis:
Psoriatic arthritis is characterized by painful joint and skin inflammation. There are more than 1.5 million patients in the United States who are suffering from psoriatic arthritis.
For a pipeline, market overview, SLRs, and market access reports (syndicate and customized), please write to firstname.lastname@example.org