A review was recently conducted among 2 different types of randomized clinical trials in the treatment of rheumatoid arthritis (RA): those comparing reference biologics’ efficacy versus placebo, and those comparing reference biologics’ efficacy versus biosimilars.
A review was recently conducted among 2 different types of randomized clinical trials in the treatment of rheumatoid arthritis (RA): those comparing reference biologics’ efficacy versus placebo, and those comparing reference biologics’ efficacy versus biosimilars. The researchers performed a systematic review of literature and meta-analysis of the data, the results of which will be presented during the American College of Rheumatology (ACR) Annual Meeting in Chicago, Illinois, held from October 19-24, 2018.
The study’s authors searched for randomized, double-blind, placebo-controlled or biosimilar controlled trials in RA. The review included randomized clinical trials in those with inadequate response to methotrexate and other disease-modifying anti-rheumatic drugs. However, randomized clinical trials involving monotherapy, methotrexate-naïve patients, or those who responded inadequately to biologics were excluded. In total, the review included 22 articles: 12 reference—placebo trials and 10 reference–biosimilar trials. The primary endpoint was the American College of Rheumatology’s criteria for a 20% improvement (ACR20).
The treatment timeframe for each group was approximately 24 weeks, and the characteristics of the population such as disease duration, disease activity, seropositivity, and methotrexate dose were similar. The global rates of ACR20 responders in both groups were calculated by performing a meta-analysis.
For the reference—placebo group, the global rate of ACR20 response was 58% (range, 54%-62%). In the reference–biosimilar group, however, the global ACR20 response rate was 70% (64%-76%). The researchers also evaluated the global rate of the American College of Rheumatology 50% (ACR50) response. In the reference–placebo group, ACR50 rate was 34% (30%-39%), whereas the rate for the reference–biosimilar group was 44% (37%-51%).
The researchers concluded that “The efficacy of reference agents is better in recent non-inferiority [randomized clinical trials] where all patients were treated with the reference agents or [a] biosimilar, than in pivotal [randomized clinical trials] where the patients could potentially be treated with the biologic agents or a placebo.” Notably, the authors say that a nocebo effect could explain lower efficacy found in reference—placebo trials.
Reference
Lopez L, Richez C, Truchetet ME, et al. Efficacy of the reference biologic agents in two different types of randomized clinical trials: 1/ the ones comparing their efficacy vs. placebo and 2/ the ones comparing their efficacy vs. biosimilar in rheumatoid arthritis: a systematic review of literature and meta-analysis. Presented at the American College of Rheumatology 2018 meeting, October 19-24, 2018; Chicago, Illinois. Abstract 2520.https://acrabstracts.org/abstract/efficacy-of-the-reference-biologic-agents-in-two-different-types-of-randomized-clinical-trials-1-the-ones-comparing-their-efficacy-vs-placebo-and-2-the-ones-comparing-their-efficacy-vs-biosimilar/.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
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.
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.