Johnson & Johnson (J&J) has reported that Tremfya (guselkumab) minimised the symptoms and signs of active psoriatic arthritis (PsA) at 24 weeks in individuals, against a placebo in the randomised Phase IIIb APEX trial.
The double-blind, placebo-controlled, multi-centre trial involves individuals with active PsA who are biologic naïve and do not have an adequate response to standard treatments.
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It includes a 24-week double-blind period, followed by a 24-week active treatment duration and a 12-week safety follow-up.
An additional two-year active treatment period is available for those entering the long-term extension before the final safety follow-up.
The trial demonstrated that this fully-human, dual-acting monoclonal antibody inhibited the advancement of the joint structural damage, along with space narrowing and joint erosions at week 24, as per the PsA modified van der Heijde-Sharp (vdH-S) score measurements.
The mean change from baseline to this week in the modified vdH-S score was found to be 0.55 and 0.54 for those who were being given Tremfya every four weeks (Q4W) and every eight weeks (Q8W), respectively, against 1.35 in the placebo group.
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By GlobalDataAdditionally, 67% (Q4W) and 63% (Q8W) of Tremfya-treated subjects experienced no radiographic progression, against 53% in the placebo group.
According to the company, the antibody also improved joint and skin symptoms in active PsA patients, with significantly greater proportions of patients achieving the American College of Rheumatology response criteria (ACR20) at week 24 versus those receiving placebo.
Over twice as many Tremfya-treated subjects achieved ACR50 at week 24. In terms of skin clearance, a greater proportion of patients treated with the antibody achieved an Investigator’s Global Assessment (IGA) score of 0/1, indicating clear or almost clear skin, compared to those on placebo.
The safety profile of the antibody was found to be consistent with previous data, without any safety signals observed.
Johnson & Johnson Innovative Medicine rheumatology disease area leader and vice-president Terence Rooney said: “With these results from the APEX study, Tremfya has set a new bar for joint preservation as the only IL-23 inhibitor proven to significantly inhibit structural damage in active psoriatic arthritis, an inflammatory arthritis that can develop in up to 30% of people living with psoriasis.”
Earlier this year, Tremfya also showed success in a Phase III trial for ulcerative colitis, with 27.6% of subjects achieving clinical remission.
