“The common initiation in North America of infliximab as monotherapy is concerning, given the now substantial body of evidence…documenting the importance of concomitant [immunomodulators] in reducing the likelihood of secondary loss of responsiveness related to anti-infliximab antibodies," write the researchers.
The use of anti—tumor necrosis factor (anti-TNF) drugs, which are highly effective in treating pediatric inflammatory bowel disease (IBD), varies in different global territories. A recent initiative of the international Pediatric IBD Network (PIBDNet) explored regional differences in anti-TNF use in pediatric IBD in order to help understand regional differences and how those differences may impact a patient’s outcomes.
PIBDNet developed an electronic survey that was sent to all members who are physicians treating pediatric IBD, and responses were gathered from 344 providers in 43 countries (54% in North America, 29% in Europe, 6% in Oceania, 6% in Asia, 3% in Africa, and 2% in South America). The respondents each treated a median of 40 patients with IBD.
The survey explored practice patterns, including the percentage of patients who were given anti-TNF therapy, the percentage of the time that anti-TNF agents were used as the first line of therapy, how often a patient was given infliximab versus adalimumab, choice of immunomodulator, and other issues.
The researchers found that North American physicians used anti-TNF agents as first-line therapy 80% of the time in treating Crohn disease (CD), versus 38% of the time in Europe and 30% of the time in other territories. North Americans also used infliximab (though not adalimumab) in combination with an immunomodulator less often in both patients naïve to immunomodulation and in those who had failed prior treatment.
While physicians worldwide used similar adalimumab induction regimens and similar treatment intensification protocols, North Americans were also less likely (42%) than other physicians (90% in Europe and 100% elsewhere) to adhere strictly to standard infliximab induction protocols.
In treating ulcerative colitis (UC), anti-TNF drug use was also higher in North America, with a median of 20% of patients receiving anti-TNF agents in North America versus 10% in Europe and 5% elsewhere. Infliximab was the most used first anti-TNF agent in all areas. As in CD, physicians treating UC used the drug more frequently as a first-line therapy (76% of the time) than did physicians in Europe (47%) or elsewhere (36%).
Interestingly, more routine testing, such as testing for tuberculosis, before starting anti-TNF therapy was undertaken in Europe (95% of cases) versus North America (90% of cases) or elsewhere (83%). However, after starting therapy, more annual screening was performed in North America (39% of cases) than Europe (14% of cases) or elsewhere (16% of cases).
The researchers concluded that the use of anti-TNFs varies significantly in North America from the rest of the world.
“Our North American pediatric data are very different from adult surveys of the American Gastroenterological Association in 2009 and of gastroenterologists in Maryland and Washington, DC, in 2007, where 70% and 48% of respondents, respectively, said they would use [immunomodulators] prior to prescribing [infliximab],” wrote the authors.
They add that “The common initiation in North America of infliximab as monotherapy is concerning, given the now substantial body of evidence…documenting the importance of concomitant [immunomodulators] in reducing the likelihood of secondary loss of responsiveness related to anti-infliximab antibodies.”
Reference
Church PC, Hyams J, Ruemmele F, de Ridder L, Turner D, Griffiths AM. The continental divide: anti-TNF use in pediatric IBD is different in North America compared to other parts of the world. Can J Gastroenterol Hepatol. 2018;2018:3190548. doi: 10.1155/2018/3190548.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
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 Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
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.