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.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
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.
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
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.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.