Yuflyma Demonstrates Continued Interchangeability with Humira
Results are from an open-label extension of a phase 3 trial assessing the pharmacokinetics, efficacy, safety, and immunogenicity of adalimumab-aaty and its reference formulation Humira.
Adalimumab-aaty (Yuflyma) has demonstrated continued success in treating patients with moderate-to-severe chronic plaque psoriasis when compared to the reference formulation (Humira), according to data published in Dermatology and Therapy.1 Results from the study further support interchangeability between reference adalimumab and adalimumab-aaty.
“A biosimilar is a medicine made using living cells that is highly similar to an original (‘reference’) medicine,” wrote authors of the study. “As biosimilars are typically cheaper than reference medicines, their use may make it easier for patients to get treatment. CT-P17, approved to treat inflammatory conditions, is a biosimilar of a reference medicine called adalimumab.”
Interchangeability of adalimumab formulations could make life exponentially easier for patients with psoriasis and pharmacists as well. | image credit: Javier / stock.adobe.com
Adalimumab-aaty, previously known as CT-P17, was approved by the FDA in May 2023 as a biosimilar to Humira.2 Less than a year later, adalimumab-aaty received interchangeability designation, meaning both adalimumab-aaty and the reference adalimumab could be used at the same effectiveness.3
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With adalimumab-aaty previously exhibiting efficacy and safety in patients with psoriasis, researchers wanted to further understand the interchangeability between the 2 formulations. AbbVie’s Humira formulation of adalimumab controlled the marketplace for about 20 years, and collected $200 billion in revenue, before the first adalimumab biosimilar (Amjevita) was approved in early 2023.4
Since then, several biosimilars have been approved, including adalimumab-aaty. As researchers of the current study further explore interchangeability, successful results could make life exponentially easier for patients with psoriasis and pharmacists as well.
“[Interchangeability] would allow pharmacists to dispense CT-P17 directly when reference adalimumab is initially prescribed, providing flexibility, timely treatment access, and potentially reducing patient costs,” continued the authors.1 “In this study, patients with psoriasis were switched between CT-P17 and adalimumab multiple times (switching period).”
With the goal of further demonstrating adalimumab-aaty’s interchangeability, they conducted a repeated-switch scenario for 52 weeks. In a randomized, double-blind, phase 3 study, patients with moderate-to-severe chronic plaque psoriasis were given reference adalimumab on day 1, half the dose 1 week later, and another dose every other week until week 11.
By week 13, researchers began randomizing patients to either continue taking reference adalimumab (“continuous group”) or switch repeatedly between reference adalimumab and adalimumab-aaty until week 25 (“switching group”). After week 25, patients entered an open-label extension (OLE) period where adalimumab-aaty was administered every other week. Researchers collected data on pharmacokinetics (PK), efficacy, safety, and immunogenicity.1
A total of 346 patients were included in the final analysis. Of the patient population, 152 were included in the “switching group” and 160 patients were in the “continuous group.”
“Results showed that [adalimumab-aaty] can be used interchangeably with reference adalimumab by demonstrating similar PK (how the body absorbs, processes, and excretes a drug), effectiveness, safety, and immunogenicity (risk of unwanted immune reactions) between patients who switched medicines and those receiving reference adalimumab throughout,” they wrote.1
Indeed, adalimumab-aaty showed continued success as an interchangeable version of Humira. Improvements in efficacy were identified up to week 27, were maintained during the OLE, and demonstrated comparability between patients on either formulation. At week 52, psoriasis severity improved by an overall mean of 90.34%.
“In the present 52-week analysis, PK, efficacy, safety, and immunogenicity findings with CT-P17 and reference adalimumab remained similar throughout the OLE (week 27-52) of this phase 3 study in patients with moderate-to-severe chronic plaque psoriasis, regardless of prior treatment, and were also generally comparable across time points,” continued the authors.1 “These longer-term, open-label data support the study’s primary findings at week 27 and the previously reported interchangeability of CT-P17 and reference adalimumab.”
With the continued success of adalimumab-aaty in treating chronic plaque psoriasis, future studies may explore interchangeability of other Humira biosimilars, such as adalimumab-aacf (Idacio), adalimumab-adaz (Hyrimoz), or adalimumab-adbm (Cyltezo), to name a few.2
“This further supports the interchangeability of CT-P17 and reference adalimumab for the treatment of moderate-to-severe plaque psoriasis,” concluded authors of the current study.1
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