New Data Shows TREMFYA Improved Psoriatic Arthritis Symptoms through One Year

Janssen announced longer-term results from a Phase 2 study investigating TREMFYA (guselkumab), the first selective anti-interleukin (IL)-23 monoclonal antibody to show positive results in the treatment of active psoriatic arthritis. According to findings presented at the 2017 ACR/ARHP Annual Meeting, more than 70 percent of patients receiving TREMFYA 100 mg subcutaneous injections achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) using observed data at week 56. These data follow initial results that showed 58 percent of patients treated with TREMFYA achieved an ACR 20 response at week 24, the primary endpoint of the study, compared with 18.4 percent of patients receiving placebo (p<0.001). Based on the Phase 2 study results, Janssen has initiated two Phase 3 studies to evaluate the efficacy and safety of TREMFYA in the treatment of patients with active psoriatic arthritis who may have been previously treated with anti-tumor necrosis factor (TNF) alpha therapies (DISCOVER-1), and in patients who have not received prior treatment with a biologic therapy (DISCOVER-2).

TREMFYA received U.S. Food and Drug Administration (FDA) approval in July for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and in September the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization in the European Union for the use of TREMFYA in the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

"Patients with active psoriatic arthritis live with substantial disease burden, experiencing joint pain, swelling and stiffness, along with painful skin plaques associated with psoriasis," said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and study steering committee member. "It is encouraging to see that patients receiving this IL-23 inhibitor demonstrated improvement in symptoms of active psoriatic arthritis at week 24, and results were maintained through one year with guselkumab therapy. I look forward to future results from the Phase 3 trials."

The Phase 2 study met all primary and secondary endpoints with statistical significance at week 24. At week 24, patients in the placebo group crossed over to receive TREMFYA, and patients originally randomized to active treatment continued TREMFYA therapy, both groups receiving every eight-week therapy (after 2 starter doses at weeks 0 and 4) with the final injection administered at week 44.

At week 56, based on the observed data, signs and symptoms of psoriatic arthritis including tender and swollen joints, pain and physical function [measured by the health assessment questionnaire-disability index (HAQ-DI) score], levels of skin clearance (PASI improvements) and patient-reported quality of life outcomes (measured by the SF-36 questionnaire) improved through week 24 and were maintained through week 56 in patients treated with TREMFYA.

Post-week 24, there were no observed differences in adverse event (AE) rates among patients with differing lengths of exposure to TREMFYA. Through week 56, 40 percent of all patients experienced AEs, the most common of which were infections. Serious AEs were reported in six percent of patients and included one myocardial infarction and one malignancy (basal cell carcinoma).