As AbbVie’s best-selling Humira faces oncoming biosimilar competition, the drug maker is developing a new innovator product that could help it retain a hold on the market; new results from 3 phase 3 clinical trials show AbbVie’s investigational interleukin-23 inhibitor, risankizumab, to be more effective than adalimumab (Humira) or ustekinumab (Stelara) in patients with moderate-to-severe plaque psoriasis.
As AbbVie’s best-selling Humira faces oncoming biosimilar competition, the drug maker is developing a new innovator product that could help it retain a hold on the market; new results from 3 recent phase 3 clinical trials show AbbVie’s investigational interleukin-23 (IL-23) inhibitor, risankizumab, to be more effective than adalimumab (Humira) or ustekinumab (Stelara) in patients with moderate-to-severe plaque psoriasis.
All 3 trials met the co-primary endpoints of at least a 90% improvement in symptoms in the Psoriasis Area and Severity Index (PASI 90), and a score of clear or almost clear as measured by the static Physician Global Assessment (sPGA) scale at week 16, compared with placebo or adalimumab.
“What is particularly exciting is the number of patients who achieved high rates of skin clearance in these 3 head-to-head clinical trials,” said Michael Severino, MD, AbbVie’s executive vice president of research and development and chief scientific officer. “Risankizumab has the potential to provide a meaningful new treatment option for people living with psoriasis.”
Two of the trials reported [ultIMMA-1 (n = 506) and ultIMMa-2 (n= 491)] were replicate phase 3 trials evaluating the safety and efficacy of risankizumab (150 mg) compared with placebo or ustekinumab (45 mg or 90 mg based on patient weight). The third trial, IMMvent, studied risankizumab versus adalimumab (n = 605).
AbbVie notes that phase 3 trials of risankizumab in psoriasis are ongoing, and the drug is also being investigated to treat Crohn’s disease and psoriatic arthritis. Future trials are planned to investigate risankizumab in ulcerative colitis.
Risankizumab Versus Placebo or Ustekinumab (ultIMMA-1 and ultIMMa-2)
After 16 weeks of treatment, 75% of patients receiving risankizumab in both studies achieved a response of PASO 90, compared with 5% of patients receiving placebo in ultIMMa-1 and 2% receiving placebo in ultIMMa-2. These response rates were significantly greater than the ustekinumab PASI 90 response rates of 42% (ultIMMa-1) and 48% (ultIMMa-2). Additionally:
Risankizumab Versus Adalimumab (IMMvent)
IMMvent data showed that patients receiving risankizumab had significantly higher response rates than those receiving adalimumab:
In the second phase of IMMvent (week 16 to 44), patients with a response to adalimumab of PASI 50 to less than PASI 90 at week 16 were re-randomized to either switch to risankizumab or continue adalimumab. Of these patients:
“In this trial, 4 out of 5 patients achieved clear or almost clear skin with risankizumab at week 16,” noted Kristian Reich, MD, the principal investigator for IMMvent. He said the results support previous findings that risankizumab has the potential to address unmet needs for patients with psoriasis.
No new safety signals were detected across the phase 3 program for plaque psoriasis. In ultIMMa-1 and ultIMMa-2, serious adverse events through week 16 occurred in 2% of patients on risankizumab in both studies, compared with 3% and 1% of patients on placebo and 8% and 3% of patients on ustekinumab, respectively.
Through 1 year, SAEs in the ultIMMa-1 and ultIMMa-2 trials occurred in 8% and 7% of patients in the continuous risankizumab group, respectively, compared with 11% and 7% of patients treated continuously with ustekinumab. One patient in ultIMMa-2 receiving risankizumab died from a sudden cardiac arrest 101 days after the last dose of study drug; a second patient receiving risankizumab died 161 days after the last dose (cause of death is unknown). Both patients had a history of cardiovascular risk factors. There were no deaths reported among patients in ultIMMa-1.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.