Risankizumab treats moderate to severe chronic plaque psoriasis.
AbbVie recently announced positive results from three phase 3 clinical trials investigating risankizumab, an investigational IL-23 inhibitor, in patients with psoriasis.
The investigational drug met co-primary endpoints and outperformed 2 psoriasis drugs, ustekinuab and adalimumab, according to a press release.
AbbVie reported that the results of the clinical trials showed that after 16 weeks of risankizumab therapy, a majority of patients achieved at least 90% improvement in the Psoriasis Area and Severity index (PASI 90) and static Physician Global Assessment score of clear or almost clear (sPGA 0/1) compared with placebo or adalimumab, according to the release.
"We are encouraged by these positive results for risankizumab. What is particularly exciting is the number of patients who achieved high rates of skin clearance in these 3 head-to-head clinical trials. Risankizumab has the potential to provide a meaningful new treatment option for people living with psoriasis," said Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to advancing care for patients with immune-mediated diseases. We are building on our two decades of expertise as a leader in immunology to develop a robust portfolio of innovative therapies addressing continued unmet needs."
In the uItIMMa-1 and ultIMMa-2 trials, the investigators analyzed the safety and efficacy of risankizumab compared with placebo or ustekinumab.
At 16 weeks, 75% of risankizumab-treated patients across both studies achieved PASI 90, while only 5% of placebo patients in uItIMMa-1 and 2% in ultIMMa-2 achieved this result, according to the release. Additionally, only 42% and 48% of patients treated with ustekinumab in uItIMMa-1 and ultIMMa-2 achieved this, respectively.
Approximately 88% and 84% of patients in uItIMMa-1 and ultIMMa-2 achieved sPGA 0/1, respectively, which was significantly greater than the scores in patients treated with ustekinumab, according to AbbVie.
Notably, at 16 weeks and at 1 year, twice as many risankizumab-treated patients achieved total skin clearance compared with ustekinumab. AbbVie reported that all primary and secondary endpoints were statistically significant compared with placebo and ustekinumab.
"Skin clearance is an important goal of treatment and remains an unmet need for many of our patients who suffer from psoriasis. By showing superior efficacy in these two trials, these data support the potential for risankizumab to be an impactful treatment for our patients," said principal investigator of the ultIMMa-1 study Kenneth B. Gordon, MD.
In the IMMvent study, 72% of patients treated with risankizumab achieved PASI 90 compared with only 47% of adalimumab-treated patients who achieved this at 16 weeks, according to the release. Additionally, 40% of risankizumab patients and 23% of adalimumab patients achieved complete skin clearance.
At week sixteen, 84% of patients treated with risankizumab achieved sPGA 0/1, while only 60% of patients treated with adalimumab achieved this, according to AbbVie.
In an extension, patients who had a response of PASI 50 to PASI 90 to adalimumab were randomized to continue therapy or switch to risankizumab.
The investigators discovered that 66% of patients who switched achieved PASI 90 at week 44, while only 21% of patients who continued therapy achieved PASI 90, according to the release.
"In this trial, 4 out of 5 patients achieved clear or almost clear skin with risankizumab at week 16. High levels of skin clearance, PASI 90, were also seen at week 44 for patients who received risankizumab, with a 12-week dosing regimen," said principal investigator of the IMMvent study Kristian Reich, MD. "These data support previous results showing the potential of risankizumab to address unmet needs for patients suffering from psoriasis."