Currently, beyond the evaluation of a patient’s 28-joint disease activity score (DAS28), there are no standard methods to determine whether patients will respond well to dose reduction of anti–tumor necrosis factor therapy.
Dose tapering or discontinuation of anti—tumor necrosis factor (anti-TNF) therapy has been shown to be safe and effective in certain patients with rheumatoid arthritis (RA). However, beyond the evaluation of a patient’s 28-joint disease activity score (DAS28), there are no standard methods to determine whether patients will respond well to dose reduction.
Researchers have identified mental health as a possible marker for disease flare due to the connection between poor mental health and its possible influence on symptom reporting and interference with self-management behavior. In addition, poor mental health has been associated with increased pain and fatigue, as well as higher disease activity in patients with RA.
A study newly published in Rheumatic and Musculoskeletal Diseases sought to evaluate whether fatigue, baseline mental health (assessed via depression, anxiety, or low mood), and functional states (as measured by self-reported questionnaires) can indicate the risk of flares in patients who are tapering therapy.
Researchers analyzed results from the Optimizing TNF Tapering in RA (OPTTIRA) trial, a multicenter, prospective, randomized, open-label study that investigated anti-TNF tapering in patients with RA who were in sustained low disease activity (LDA).
The study comprised 2 phases: the randomized, controlled, open-label, proof-of-principle phase (from month 0 to month 6), followed by the open, exploratory phase (month 6 to month 12) for patients who completed the initial trial period.
Between 2011 and 2013, 244 patients were screened, 103 were randomized, and 97 accepted their allocated treatment. The majority of patients participating in the study were receiving methotrexate in combination with their anti-TNF therapy (n = 67, 69%) and the median disease duration was 11 years (interquartile range, 7-17), with 73 patients (75%) fulfilling DAS28 remission criteria (a DAS28 score of less than 2.6).
In the first phase of the study, 3 patients who tapered anti-TNF therapy by 33% (experimental group 1) and 6 patients who tapered anti-TNF therapy by 66% (experimental group 2) flared, versus 8 patients in the control arm.
In the second phase, flares were observed in 9 patients in experimental group 1 and 4 patients in experimental group 2 who continued to taper therapy until complete termination of treatment. Of the control group, 3 patients who tapered anti-TNF treatment by 33% and 8 patients who tapered anti-TNF agents by 66% flared.
Overall, a higher DAS28 score at the start of the study was associated with an increased risk of flare. The association remained significant even after adjusting for co-variates (HR, 1.96; 95% CI, 1.18-3.24; P =.04).
A fatigue and a short-form mental health survey (SF-36) also predicted flare in univariate models, but when analyses were adjusted, only mental health continued to be a statistically significant predictor of flare (adjusted HR per 10 units, 0.74; 95% CI, 0.60-0.93; P =.01).
The researchers concluded that baseline depression as measured by SF-36 mental health scale, as well as DAS28, can independently predict flare events in patients with sustained LDA who taper anti-TNF therapy. Based on the findings of the analysis, researchers have recommended that an assessment of mental health and functional status should be considered prior to beginning dose reduction in patients with RA.
Reference
Bechman K, Sin EF, Ibrahim F, et al. Mental health, fatigue and function are associated with increased risk of disease flare following TNF inhibitor tapering in patients with rheumatoid arthritis: an exploratory analysis of data from the Optimizing TNF Tapering in RA (OPTTIRA) trial. RMD Open. 2018; 4(1):e000676. doi: 10.1136/rmdopen-2018-000676.
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.