Johnson & Johnson's Janssen Pharmaceutical unit announced Wednesday that in a Phase III study, Tremfya (guselkumab) was superior to Novartis' Cosentyx (secukinumab) in treating adults with moderate-to-severe plaque psoriasis. Johnson & Johnson noted that results from the ECLIPSE trial, which were presented at the Inflammatory Skin Disease Summit, mark "the first-ever results from a head-to-head study comparing an IL-23-targeted biologic therapy with an IL-17 inhibitor."
In the trial, 1048 adults with moderate-to-severe plaque psoriasis were randomly assigned to treatment with Tremfya, given subcutaneously at weeks zero, four and 12 followed by treatment every eight weeks, or Cosentyx administered twice weekly for five weeks followed by treatment every four weeks thereafter. The study's primary endpoint was the proportion of patients exhibiting a 90-percent improvement on the Psoriasis Area Severity Index (PASI 90) at week 48, while secondary goals were measured at weeks 12 and 48.
Findings for the primary endpoint showed that 84.5 percent of patients treated with Tremfya achieved PASI 90 at week 48, compared with 70 percent of those who received Cosentyx. Johnson & Johnson added that Tremfya demonstrated non-inferiority to Cosentyx on a key secondary goal, with 84.6 percent of patients achieving a PASI 75 response at both weeks 12 and 48, compared to 80.2 percent for Cosentyx, although the finding did not demonstrate superiority.
Johnson & Johnson noted that as superiority was not demonstrated for this secondary endpoint, p-values for all the subsequent five major secondary goals were considered nominal. The company indicated that the PASI 100 rates at week 48 were 58.2 percent in the Tremfya arm and 48.8 percent in the Cosentyx group. Meanwhile, 62.2 percent of patients who received Tremfya achieved an Investigator's Global Assessment score of 0, versus 50.4 percent of those treated with Cosentyx.
Regarding the non-inferiority of Tremfya versus Cosentyx at week 12, 89.3 percent of patients in the Tremfya arm achieved PASI 75 responses, compared to 91.6 percent of Cosentyx-treated patients. Moreover, the PASI 90 rates in these groups were 69.1 percent and 76.1 percent, respectively.
Commenting on the results, study investigator Richard Langley said "the response-over-time curves show that maximum response rates with Tremfya are achieved after six months and are maintained over time through one year." Langley added that the data "confirm a slightly more rapid onset of response with Cosentyx, but importantly, in a chronic disease like psoriasis, these data provide new insights into comparative longer-term efficacy."
Tremfya was approved in the US and EU last year for use in adults with moderate-to-severe plaque psoriasis who are suitable for systemic therapy or phototherapy. The therapy was developed using MorphoSys' HuCAL technology platform, with the company indicating earlier this week that positive results were shortly expected from the ECLIPSE study.
In October, Novartis reported that sales of Cosentyx grew 35 percent year-over-year to $750 million, with growth seen in the US and EU, where the drug garnered approval in 2015. Earlier this year, Novartis initiated a mid-stage head-to-head study comparing Cosentyx to Tremfya in patients with psoriatic plaques resistant to treatment with Johnson & Johnson's Stelara (ustekinumab), with results expected next year. For related analysis, see ViewPoints: Head-to-head studies increasingly the norm for ultra-competitive pharma.
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