Japanese investigators say more needs to be known about what happens post treatment with biosimilar infliximab in patients with rheumatoid arthritis (RA).
Japanese investigators hope to shed light on durability of clinical remission in rheumatoid arthritis (RA) following discontinuation of treatment with an infliximab biosimilar (CT-P13, Remsima).
“It is the next great issue whether disease activity can be maintained…after discontinuation of CT-P13, because no evidence is available” regarding the clinical outcome after biosimilar infliximab is stopped in RA, they wrote.
Rheumatoid arthritis is a chronic, systemic inflammatory disease that when uncontrolled can lead to joint destruction and deformity, lowering patients’ quality of life. Advances in the use of biologic disease modifying antirheumatic drugs, including biosimilars, have improved clinical outcomes, leading to low disease activity and clinical remission.
In the ongoing IFX-SIRIUS STUDY I, investigators are evaluating whether continued treatment with biosimilar infliximab is not inferior to treatment with the originator product in maintaining nonclinical relapse. The new study, IFX-SIRIUS STUDY II, continues with the evaluation of what happens once treatment with the biosimilar is stopped.
The clinical findings will be important, the investigators note, because infliximab is a costly drug whether the originator or a biosimilar is used. Therefore, it is important to know if disease activity can be suppressed following discontinuation of the biosimilar in patients with RA.
Previous Findings Show Lasting Benefit
Previous studies have suggested that the disease can be controlled following treatment cessation with antirheumatic drugs, so the investigators expect encouraging findings from IFX-SIRIUS STUDY II. According to findings published in 2010, of 102 patients with RA, 55% of those who attained low disease activity on infliximab were able to discontinue the drug for more than 1 year without radiologically detectable joint destruction.
Results from the HONOR study, reported in 2016, suggested the same long-term, medication-free benefit. The study enrolled 197 patients with RA treated with adalimumab. One year after discontinuation, 79% of patients who began the period with deep remission had not experienced flaring of inflammation and showed no functional or structural damage. The study also found that readministration of the drug to patients with flare-ups was effective in controlling RA.
Despite such findings, more needs to be known about “optimal approaches for discontinuation,” the investigators wrote.
In IFX-SIRIUS STUDY II, disease activity will be measured by musculoskeletal ultrasound as well as by clinical disease activity in order to accurately assess inflammation at the joint level. Investigators will also measure serum levels of cytokines and chemokines to determine whether these biomarkers can predict nonclinical relapse after discontinuation of biosimilar infliximab.
“We expect that a certain proportion of patients with RA will have clinical relapse after discontinuation of CT-P13; thus, we will also evaluate the effectiveness and safety of CT-P13 retreatment in patients with RA who have clinical relapse,” they said.
The prospective, interventional, single-arm, multicenter study based in Japan will begin with enrollment of ≤ 80 patients and baseline screening, followed by evaluations at 3-month intervals and final evaluation at 48 weeks. For enrollment, patients must have been on biosimilar infliximab during the IFX-SIRIUS STUDY I and have experienced a nonclinical relapse during that study period.
Patients will discontinue CT-P13 at points throughout the study period, and if they have a relapse following discontinuation, CT-P13 will be readministered.
The primary end point is the proportion of patients who had clinical relapse during the 48-week period.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
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.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.