On December 12, Janssen announced the 48-week results of the head-to-head PKECLIPSE Phase III study of Tremfya (guselkumab) and Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis. In the Tremfya treatment group, the psoriasis area and severity index improved by more than 90% (PASI 90, primary endpoint) by 84.5%, compared with 70% in the Cosentyx treatment group, and Tremfya was superior to Cosentyx. The detailed results of the study will be published at the 3rd Inflammatory Skin Disease Summit Forum on December 12-15.
The PKECLIPSE study was a multicenter, randomized, double-blind study comparing the efficacy and safety of Tremfya with Cosentyx in 1048 patients with moderate to severe adult psoriasis. In the Tremfya treatment group, 100 mg of the test drug was administered subcutaneously at 0, 4, and 12 weeks, and then once every 8 weeks. Cosentyx was given a dose of 300 mg (150 mg x 2) of the control drug subcutaneously at 0, 1, 2, 3, and 4 weeks, and then once every 4 weeks.
The PKECLIPSE study also set six secondary endpoints, including week 12 and week 48 PASI 75, week 48 PASI 100, week 48 IGA score (researcher’s overall assessment) was 0 (skin clean), 0 Or 1 (the proportion of patients with completely clean skin or minimal disease).
At week 48, the proportion of patients who achieved PASI 100 (100% improvement in psoriasis area and severity index compared with baseline) in the Tremfya treatment group was 58.2%, and the proportion of patients with IGA score 0 was 62.2%; the proportion of PASI 100 patients in the Cosentyx treatment group was 48.4%, the proportion of patients with IGA 0 was 50.4%.
At week 12, the proportion of patients who achieved PASI 75 in the Tremfya treatment group was 89.3%, the proportion of patients with PASI 90 was 69.1%, and that in the Cosentyx treatment group was 91.6% and 76.1%, respectively.
In terms of safety, the performance of the two drugs was consistent with previous studies, and the proportion of patients with at least one adverse event was close, at 77.9% and 81.6%, respectively. At week 44, 27 patients (5.1%) in the Tremfya treatment group discontinued treatment, and 48 patients (9.3%) in the Cosentyx treatment group.
Professor Richard Langley of the Dalhousie University School of Medicine commented: “The patient’s response to Tremfya increased with the treatment time, reached the highest level after 6 months of treatment, and performed better at the primary endpoint. This study suggests that Cosentyx The onset time is faster, but for chronic diseases like psoriasis, Tremfya is more prominent in terms of long-term efficacy.”
Psoriasis is a chronic, autoimmune skin disease with approximately 125 million patients worldwide. Plaque psoriasis is the most common form of psoriasis, and scalp psoriasis is also seen in 50% of patients with psoriasis, with approximately 30% of patients with psoriasis having or progressing to psoriatic arthritis. Although a variety of drugs have been approved for the treatment of psoriasis, because psoriasis can not be cured, existing drugs can only improve the symptoms of the disease, so the psoriasis drug market is very an area of ”Qian Jing”.
Cosentyx is the world’s first marketed IL-17A monoclonal antibody, achieving an impressive $1.128 billion in the second year of FDA approval. Currently approved indications include plaque psoriasis and psoriasis joints. Inflammation and compulsory spondylitis have become the pillar products of Novartis in the field of autoimmune diseases. Cosentyx’s global sales in 2017 was $2.071 billion, and sales for the first nine months of this year were $2.031 billion.
After Novartis entered the field of Johnson & Johnson as a challenger, although Johnson’s old psoriasis product Stelara continued to grow well with the expansion of the market, Cosentyx was strong, IL-17A Drugs have been approved in succession, and these fierce students have made Johnson and Johnson extremely uneasy.
Tremfya belongs to the monoclonal antibody targeting IL-23 and is an upgraded product of Stelara. It has become a weapon for Johnson & Johnson to suppress opponents. On July 13, 2017, Tremfya was approved by the FDA for approval four months in advance, thanks to a prioritized review voucher. Moreover, Johnson & Johnson is also very flexible in terms of price. By working closely with payers and pharmacy welfare management agencies, Tremfya will inject six $58,100 discounts to $45,000. For patients who meet the conditions of assistance, Johnson & Johnson works with the insurer to allow the patient to pay no more than $5 per bundle.
Regrettably, such a heavy product that was betrayed by Johnson & Johnson, the performance after listing must be unsatisfactory, and sales were not disclosed in the Johnson & Johnson quarterly report. What we can still see is that Stelara is always strong and strong. The sales revenue in the first three quarters of this year was 3.712 billion US dollars (+26.7%).
In fact, the reason why Tremfya is not warm after the listing is very simple, because the clinical data on which it was approved for listing is only the comparative advantage obtained from the old Humira. Unlike Cosentyx, which stepped on Humira and Stelara to the top, and continued to release new follow-up data, it set itself a new benchmark in the field of psoriasis. In addition, Stelara was backed by Lilly’s IL-17 monoclonal antibody Taltz (ixekizumab). In the IXORA-S study, Taltz’s response rate was proven to be higher than Stelara.
The publication of the PKECLIPSE Phase III study data allowed Johnson & Johnson to regain the lead in the field of psoriasis. Tremfya defeated Cosentyx head-to-head and was better in terms of long-term results. Plus, at a more competitive price, Johnson & Johnson had double insurance. Looking forward to seeing the market performance of Tremfya.