Janssen’s ‘Tremfya’ approved for psoriatic arthritis

The first IL-23 inhibitor to be approved for use in psoriatic arthritis in Korea… improved symptoms through week 52

Janssen Pharmaceutical Companies of Johnson & Johnson announced on the 5th that the Korean Ministry of Food and Drug Safety (MFDS) approved its psoriatic arthritis treatment ‘Tremfya (guselkumab)’ on March 29th.

 

With the approval, Tremfya may now be used for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug (DMARD) therapy.

 

Tremfya is the first and only interleukin (IL)-23 inhibitor to be approved for the treatment of active psoriatic arthritis in Korea.

 

Tremfya is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at week 0 and 4.

 

Patients who are at high risk for joint damage may consider 100 mg subcutaneous doses every 4 weeks according to clinical judgment and may consider using Tremfya in combination alone or with other disease-modifying antirheumatic drugs (DMARDs).

 

The approval was based on two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which demonstrated that after 100mg SC injection of Tremfya, patients with psoriatic arthritis who had an inadequate response to conventional treatment showed improved signs and symptoms, including joint symptoms and skin symptoms at week 24.

 

In DISCOVER-1, which evaluated patients who were naive to biologics or had an inadequate response to one or two standard therapies, 52% of the patients who received Tremfya every 8 weeks following two starter doses at week 0 and 4 achieved an ACR20 response at 24 weeks.

 

In addition, 50% and 26% of the patient group achieved Psoriasis Area and Severity Index 90 (PASI 90) and PASI 100 response rates respectively, showing a significant improvement compared to the placebo group.

 

In DISCOVER-2 which studied biologic-naïve patients, 64% of the patients who received Tremfya every 8 weeks achieved an ACR20 response at 24 weeks.

 

Also, 69% and 45% of the Tremfya-treated patient group achieved PASI 90 and PASI 100 response rates respectively, showing a significant improvement compared to the placebo group.

 

Integrated analysis of the two studies showed that Tremfya significantly improved enthesitis and dactylitis.

 

From baseline, 50% of the patients who had enthesitis (114/230) and 59% of the patients who had dactylitis showed symptom improvement at 24 weeks since receiving Tremfya every 8 weeks, which is a significant difference from the 29% (75/255) and 42% (65/154) of the placebo group.

 

“We are pleased to be able to provide a new treatment option to patients suffering from psoriatic arthritis in Korea with the approval of Tremfya,” said Jenny Zheng, Area Managing Director of Janssen Korea.

 

“From plaque psoriasis, palmoplantar pustulosis, to psoriatic arthritis, we hope the extended indication will allow Tremfya to be more widely used in the field of psoriasis.” Previously, Tremfya has been approved in Korea for the treatment of adult patients with plaque psoriasis in 2018, and for the treatment of palmoplantar pustulosis in 2019.