Data on the use of rituximab in treating patients with systemic lupus erythematosus (SLE) has been far from clear; 2 randomized controlled trials of rituximab in patients with SLE failed to meet their primary endpoints, while open-label trials have reported the drug’s efficacy in this indication.
Despite advances in the treatment of systemic lupus erythematosus (SLE) in recent years, a number of patients are refractory to conventional immunosuppressive therapies, or require unacceptably high doses of glucocorticoids for adequate disease control. Because B cells play a role in SLE, rituximab has been proposed as a potential treatment for SLE. However, data on the use of rituximab in this indication has been far from clear; 2 randomized controlled trials of rituximab in patients with SLE failed to meet their primary endpoints, while open-label trials have reported the drug’s efficacy in patients with refractory SLE.
In a paper newly published in Rheumatology, researchers used the British Isles Lupus Assessment Group Biologics Register to describe the baseline characteristics of patients in the United Kingdom who were initiating biologic therapy during the first 5 years of the register, and to evaluate the early efficacy of rituximab treatment in the first 6 months.
Patients (n = 270) with SLE who were aged 5 years or older and had started a new biologic therapy in the past 12 months were included. Patients were followed up at 3, 6, and 12 months, then annually for at least 2 years. Most patients were women (92%), the mean disease duration was 8.4 years (standard deviation, 8.7 years), and the majority (60%) were white. Most (74%) had 1 or more comorbidity. In total, 91% of patients were taking antimalarial drugs, and 93% were taking glucocorticoids. Among patients who started a biologic, 97% initiated treatment with rituximab.
A total of 178 patients who received rituximab completed baseline and 6-month assessments. At 3 months, 91 (51%) patients had responded to rituximab treatment, and at 6 months, 88 (49%) had responded. Another 9 (5%) patients—all of whom had required unacceptably high levels of steroids—experienced no worsening in disease control over 6 months after treatment with rituximab, and were able to reduce their steroid dosages.
A major clinical response was achieved by 33 (18.4%) patients. After rituximab treatment, disease activity increased in 26 (15%) patients at 3 months and 33 (19%) patients at 6 months, however.
There were 185 infections reported in 82 (30%) of patients, with respiratory and urinary tract infections most commonly reported.
More work will be necessary to identify predictors of response to rituximab, but, say the authors, “It is notable that almost one in five patients achieved a major clinical response at 6 months.” The authors conclude that rituximab appears to be safe and efficacious in treating refractory SLE, and that as additional biologic agents become available, inclusion of these agents in the register will allow for real-world comparison of treatments in identifying which patients will benefit from biologic therapies.
Reference
McCarthy EM, Sutton E, Nesbit S, et al. Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: results from the British Isles Lupus Assessment Group Biologics Register. Rheumatology. 2018;57(3):470-479. doi: 10.1093/rheumatology/kex395.
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.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars
April 16th 2023What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.