Nearly half of the study participants achieved complete skin at week 16, while 87% maintained the response at week 52.
Marek Honczarenko, MD, PhD
AbbVie has announced positive top-line results from IMMhance, the fourth pivotal phase 3 clinical trial evaluating risankizumab 150 mg for the treatment of patients with moderate-to-severe plaque psoriasis.
IMMhance, an ongoing phase 3 study, is designed to evaluate the safety and efficacy of risankizumab versus placebo in adult patients with moderate-to-severe plaque psoriasis. The study includes 2 phases.
“We are encouraged by the significant rates of skin clearance, maintenance of clinical response at 1 year and the safety results in the studies to-date," Marek Honczarenko, MD, PhD, vice president immunology development, AbbVie, told MD Magazine. "These data further support the potential for risankizumab to be an important new treatment option for psoriasis patients."
Results from the first phase of the IMMhance study showed that after 16 weeks of treatment, risankizumab met the co-primary endpoints of at least a 90% improvement in the Psoriasis and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1 compared to placebo).
Approximately 73% of patients receiving risankizumab achieved a PASI 90 score compared to 2% of patients receiving placebo. An sPGA 0/1 was achieved by 84% of risankizumab patients compared to 7% of patients that received the placebo.
The second phase of the study, weeks 28—104, are evaluating the safety and efficacy of continuous therapy with risankizumab versus randomized withdrawal through retreatment.
In the first phase, study findings demonstrated that nearly half (47%) of patients receiving risankizumab achieved PASI 100 compared to 1% of patients receiving the placebo. About 46% of patients receiving risankizumab achieved an sPGA 0 compared to 1% of patients receiving the placebo.
In the second phase of the study, patients randomized to risankizumab who achieved sPGA 0/1 at week 28 were re-randomized to risankizumab maintenance or placebo withdrawal. At week 32, participants that experienced a relapse were retreated with risankizumab immediately, 4 weeks later and every 12 weeks after.
The second phase primary endpoint was sPGA 0/1 at week 52. Among those participants in the maintenance group, 87% of patients maintained sPGA 0/1 at 1 year, compared to 61% of patients in the withdrawal group.
“These positive results are consistent with the previous data we have seen with risankizumab throughout the pivotal phase 3 clinical trial program,” Michael Severino, MD, executive vice president, research and development, chief scientific officer, AbbVie, said in a statement. “With a significant portion of risankizumab patients achieving high levels of skin clearance, these results add to the data supporting risankizumab’s potential to be an impactful new treatment option for patients living with psoriasis.”
The safety profile was consistent with previously reported phase 3 trials with no new safety signals detected.
Through week 16, serious adverse effects occurred in 2% of patients in the risankizumab group and 8% of patients in the placebo group.
In the second part of the study, serious adverse effects occurred in 6% of patients re-randomized to the risankizumab group and 6% of patients re-randomized to the placebo group.
One patient receiving risankizumab had intestinal adenocarcinoma and metastatic hepatic cancer and died, while a second patient treated with risankizumab died due to an unknown cause that was adjudicated as a major adverse cardiovascular event (MACE).
There were 2 additional adjudicated MACE cases: 1 event occurred in the placebo arm in the first phase, while the second occurred in the risankizumab arm in the second phase. All three MACE case patients had a previous history of cardiovascular risk factors.
“We look forward to sharing additional data from the pivotal trial program with the scientific community and regulatory authorities as we prepare to move forward with global regulatory submissions,” Severino added.
Risankizumab is part of a collaboration with Boehringer Ingelheim and AbbVie and is currently being evaluated to treat several immune-mediated conditions.
A press release was made available.