Tremfya gets FDA approval in moderate-to-severe plaque psoriasis

Janssen has announced the US Food and Drug Administration (FDA) approval of its novel drug Tremfya One-Press (guselkumab) for adults with moderate-to-severe plaque psoriasis.

The drug is the first FDA approved press patient-controlled injector, and is administered as a 100mg subcutaneous injection once every eight weeks, after starter doses at weeks 0 and 4.

In the Phase III multi centre and randomised ORION study, patient experience with One-Press was assessed through a validated Self-Injection Assessment Questionnaire (SIAQ).

The questionnaire evaluated patient experience at weeks 0, 4 and 12 on a scale of 0 (worst) to 10 (best) in factors such as self-image, self-confidence, pain and skin reactions during or after the injection, ease of use of the self-injection device and satisfaction with self-injection.

In the study a greater proportion of patients in the Tremfya group achieved an IGA score of 0 or 1 or a PASI 90 response at week 16 than in the group dosed with placebo.

“The results of the ORION study showed the administration of Tremfya with One-Press was safe and effective, providing patients with a new, more convenient way to inject their treatment,” said Laura Ferris, associate Professor, Department of Dermatology at the University of Pittsburgh Medical Centre.

She continued, “These findings are also exciting as they demonstrated that treatment with Tremfya helped half the patients achieve complete clearance with a PASI 100 response at week 16.”

Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, red lesions, or plaques, which can cause physical pain and itching.”

28th February 2019

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