Although switching patients with rheumatoid arthritis to a second biologic disease-modifying anti-rheumatic drug when their disease has failed to respond to the first agent is generally advocated, no consensus exists on whether the second agent should have the same or a different mechanism of action.
Although switching patients with rheumatoid arthritis (RA) to a second biologic disease-modifying anti-rheumatic drug (DMARD) when their disease has failed to respond to the first agent is generally advocated, no consensus exists on whether the second agent should have the same or a different mechanism of action (ie, a tumor necrosis factor-alpha [TNF-alpha] inhibitor or a non—TNF-alpha biologic). Since TNF-alpha inhibitors are the most frequently prescribed first biologic DMARD, rheumatologists face a dilemma about an ideal switching pattern.
Nanxin Li, PhD, MBA, of Analysis Group Inc, and colleagues recently sought to clarify the issue by analyzing the medical records of patients with RA in the United Kingdom, France, and Germany to assess real-world effectiveness associated with the use of several TNF-alpha inhibitors and non—TNF-alpha biologics after discontinuation of etanercept (Enbrel) treatment. The study, published in the August 2017 issue of Current Therapeutics, found that after patients discontinued treatment with etanercept, TNF-alpha inhibitors were less effective overall as second biologic DMARDs than non—TNF-alpha biologics. The study was funded by AbbVie.
All patients in the study were 18 years or older, had discontinued use of etanercept, and had initiated use of another TNF-alpha inhibitor or a non—TNF-alpha biologic between January 2014 and May 2015.
The TNF-alpha inhibitors used by the patients (n = 296) were adalimumab (n = 137) and other biologics (n = 159): certolizumab pegol, golimumab, and infliximab. The non—TNF-alpha biologics used by patients (n = 276) were abatacept and tocilizumab.
Study outcomes included the European League Against Rheumatism (EULAR) response and change in Clinical Disease Activity Index (CDAI) score. Patient characteristics at the index visit were similar across treatment groups.
Patients’ reasons for discontinuing etanercept and selecting a second biologic DMARD included inadequate response, adverse effects, and patient preference. TNF-alpha inhibitors overall were associated with a significantly lower EULAR good response rate (56.0% versus 64.4%; P <0.05) and smaller CDAI score change (—6.3 versus –7.3; P = .06) than non—TNF-alpha biologics.
A secondary analysis was conducted to compare outcomes among adalimumab, other TNF-alpha inhibitors, and non—TNF-alpha inhibitors. Rituximab was not included in the analysis because of unfavorable reimbursement decisions issued by health technology assessment authorities in the United Kingdom and France.
The proportion of patients achieving a EULAR good response was numerically higher for adalimumab than for other TNF-alpha inhibitors (61.1% versus 51.6%; P = .11) and comparable with non—TNF-alpha biologics (61.1% versus 64.4%; P = .52). Adalimumab was equally or more effective than other TNF-alpha inhibitors and non—TNF-alpha biologics, the authors said, as shown by a CDAI score change that was significantly greater than that of other TNF-alpha inhibitors (–7.1 vs –5.8; P<.05) and comparable with that of non—TNF-alpha biologics (–7.1 versus –7.3; P = .79).
The researchers said their findings were important because switching between TNF-alpha inhibitors is so common. It is important, they note, to help physicians optimize their treatment strategies. More real-world studies that compare different biologic agents used as first and second biologic DMARDs are needed to optimize a treatment algorithm for RA, to maximize clinical outcomes, and to inform policy decisions and clinical guidelines. “Future studies should evaluate and compare the clinical outcomes associated with the switch from other commonly used first-line TNF-alpha inhibitors, such as adalimumab, to another TNF-alpha inhibitor or a non—TNF-alpha biologic,” they write.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
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.
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.
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.