Avsola (infliximab-axxq) / Amgen - LARVOL DELTA

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) - P2 | N=30 | Suspended | Sponsor: Therakos LLC | Initiation date: Jan 2025 ➔ Dec 2025 | Not yet recruiting ➔ Suspended

Checkpoint inhibition • Trial initiation date • Trial suspension • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ASSOCIATED COST DIFFERENCES OF SWITCHING BETWEEN INFLIXIMAB PRODUCTS (CCCongress 2025) - "Ninety-two percent (n=1,642) of all first-time switches were from the infliximab originator to a biosimilar, with 72% (n=1,286) switching to infliximab-dyyb, 13% (n = 227) to infliximab-abda and 7% (n=129) to infliximab-axxq. The prevalence of switching to an infliximab biosimilar increased throughout the study period with more than half of infliximab product switches occurring in 2021. Cost savings following a switch was most significant in 2019. This study did not demonstrate any savings for patients when switching infliximab products."

Pediatrics

Infliximab Biosimilars in Pediatric Inflammatory Bowel Disease: Comparison and Adverse Effects (AIBD 2024) - " A retrospective chart review was conducted on the potential acute AEs experienced by patients receiving either infliximab infusions or 1 of 3 infliximab biosimilar infusions: infliximab-dyyb, infliximab-abda, or infliximab-axxq...All patients were premedicated with acetaminophen and diphenhydramine... Infusions of infliximab biosimilars were not associated with an increase of acute infusion reactions compared with infliximab infusions indicating that biosimilar infusions are well-tolerated and safe to use for treatment of IBD in pediatric patients. No adverse events were noted when interchanging between Infliximab and Infliximab Biosimilar."

Adverse events • Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

A Survey Among IBD Patients Following Switching From Originator Infliximab to Its Biosimilars (ACG 2024) - "Since 2016, the FDA has approved three IFX biosimilar agents (SB2), Renflexis®, Avsola™, and Inflectra®. Sixty-seven eligible patients (12 UC and 55 CD) were enrolled in the study, with 41 patients completing the survey. For question 1 (Q1), 84.6% of respondents answered "very satisfied," indicating that their providers did an excellent job counseling them on SB2. Regarding symptom control (Q2) and overall experience with SB2 (Q3), 82% and 85.4% of patients, respectively, rated their satisfaction as "Satisfied" or above."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Ulcerative Colitis

Comparison of Reference and Biosimilar Medications for Pediatric Noninfectious Uveitis. (PubMed, Int Ophthalmol Clin) - "The most common reason for biosimilar initiation was insurance mandate. Compared with the reference infliximab, pediatric patients had fewer number of flares per year on biosimilar infliximab, but they were also on the biosimilar for a shorter duration of time compared with the reference which may confound an accurate assessment. Biosimilar infliximab had a lower cost profile compared with reference infliximab."

Clinical • Journal • Retrospective data • Inflammation • Ocular Inflammation • Ophthalmology • Pediatrics • Uveitis

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Therakos, LLC, a Mallinckrodt Company

Checkpoint inhibition • New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Patterns of infliximab biosimilar uptake for Medicare, Medicaid, and private insurance from 2016-2022. (PubMed, Arthritis Rheumatol) - "Our results have two key findings for policy makers. First, our results suggest that 1 or 2 biosimilars may not generate enough competition to speed adoption rates for biosimilars. Second, Medicare, which covers most patients receiving biologics nationally, had slow adoption rates even after the third biosimilar was introduced. Policy levers to speed adoption among Medicare beneficiaries are needed."

Journal • Medicaid • Medicare • Reimbursement • US reimbursement • Rheumatology

Pembrolizumab + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2023 ➔ Jun 2025

Adverse events • Combination therapy • Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jun 2023 ➔ Jun 2030 | Trial primary completion date: Jun 2023 ➔ Jun 2030

Checkpoint inhibition • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Melanoma • Oncology • Skin Cancer • Solid Tumor • PD-1 • PD-L1

CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - P4 | N=900 | Recruiting | Sponsor: Connecticut Children's Medical Center | Phase classification: P ➔ P4

Phase classification • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology

Outcomes of the use of infliximab biosimilars in rheumatology and gastroenterology clinics. (PubMed, J Manag Care Spec Pharm) - "Clinical trials comparing infliximab biosimilars with the originator product have consistently demonstrated noninferiority, along with similar adverse effect profiles, leading to the approval of 3 additional biosimilars: Renflexis (infliximab-abda), Avsola (infliximab-axxq), and Inflectra (infliximab-dyyb). We conclude that the effort to convert clinically stable patients to a biosimilar product resulted in a significant increase in biosimilar use within the health system. This is thought to have resulted in significant financial advantages both to our institution as well as patients, without sacrificing overall clinical control."

Journal • Gastroenterology • Rheumatology

FDA Approves Infliximab Biosimilar for Subcutaneous Use Another infliximab biosimilar has been FDA approved, but this new version of Inflectra can be given subcutaneously for patients with inflammatory bowel disease. https://bit.ly/471jafo https://bit.ly/49pxZty

Regulatory

Comparing Uptake of Biosimilar Infliximab Among Patients with Medicare, Medicaid and Private Insurance in U.S. Rheumatology Practices 2016-2022 (ACR Convergence 2023) - "Background/Purpose: The first infliximab biosimilar (infliximab-dybb) entered the U.S. market in 2016, and two additional products have subsequently been introduced (infliximab-axxq (2017) and infliximab-abda (2020)). Adoption of biosimilar infliximab was quickest for Medicaid, with private insurance catching up after the release of a third biosimilar. Medicare uptake lagged significantly. To reduce drug spending, efforts are needed to understand poor Medicare uptake of biosimilars such as manufacturer rebates for biologics, and lack of financial incentives to switch to biosimilars."

Clinical • Medicaid • Medicare • Reimbursement • US reimbursement • Rheumatology

Therapeutic Hemicolectomy for Intractable Hemorrhage in New-Onset Fistulizing Crohn’s Disease (ACG 2023) - "Intravenous methylprednisolone 60mg daily with an infliximab-axxq loading regimen was ineffective as the patient required transfusion of >20 units of blood products over the course of 2 weeks. Figure: Figure 1: Multiple oozing ulcers visualized in the descending colon Figure 2: Active bleeding visualized throughout the ascending colon Figure 3: Large clot present in the sigmoid colon. Figure 4: Normal appearing ileum with an iatrogenic petechia."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Bowel Disease

Expanded table: Some drugs for inflammatory bowel disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

REMODEL-CD: Precise Infliximab Exposure and Pharmacodynamic Control (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: Children's Hospital Medical Center, Cincinnati | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics • CRP • IFNG

CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - P=N/A | N=900 | Recruiting | Sponsor: Connecticut Children's Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology

Psoriasis Biosimilars Appear to Match Up to Original Products, With Caveats (MedPageToday) - "'In the U.S., biologics comprise less than 3% of the volume of drugs on the market, but account for more than one third of all spending,' wrote Luigi Naldi, MD...'The reasons for the high cost of biologics are manifold, including the complexity of their development process, lack of competition, and high demand for their use.'"

Media quote • Psoriasis

Uptake of infliximab biosimilars among U.S. rheumatology practices through 2022 (EULAR 2023) - "Background The first infliximab biosimilar (infliximab-dybb) entered the U.S. market in 2016 and two additional products are now available (infliximab-axxq and infliximab-abda). Figure 1. Proportion of patients in the RISE registry using infliximab bio-originator or biosimilars between 2016 and 2022."

Rheumatology

TREATMENT PATTERNS OF AN INFLIXIMAB BIOSIMILAR (ABP 710) AMONG PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD): A RETROSPECTIVE US CLAIMS DATABASE ANALYSIS (DDW 2023) - "In this analysis of IBD patients who received ABP 710 (majority switched from an IFX originator), most patients persisted on treatment during a median follow-up of 295 days. The switch back rate to an IFX originator was generally low. Reasons for switching and differences in switching patterns between IFX-naïve patients and switchers were unknown and warrant further investigation."

Claims database • Retrospective data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis

CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - P=N/A | N=900 | Not yet recruiting | Sponsor: Connecticut Children's Medical Center | Trial completion date: Apr 2029 ➔ Jul 2029 | Initiation date: Apr 2023 ➔ Jul 2023 | Trial primary completion date: Apr 2028 ➔ Jul 2028

Trial completion date • Trial initiation date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology

CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (clinicaltrials.gov) - P=N/A | N=900 | Not yet recruiting | Sponsor: Connecticut Children's Medical Center

New trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology

Risankizumab (Skyrizi) - An IL-23 antagonist for Crohn's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Crohn's disease • Dermatology • Gastroenterology • Immunology • Inflammatory Bowel Disease • Psoriasis • IL23A

REMODEL-CD: Precise Infliximab Exposure and Pharmacodynamic Control (clinicaltrials.gov) - P2/3 | N=180 | Not yet recruiting | Sponsor: Children's Hospital Medical Center, Cincinnati

New P2/3 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Pediatrics • CRP • IFNG

The Evolving Spectrum of TNF Inhibitors in the Management of Psoriatic Disease - Episode 10: Psoriasis Case Impressions (DermatologyTimes) - "Mark G. Lebwohl, MD: I love your answer. I would say the same things. I'll add a couple of things that weren't said outright but that I know you meant. Both of us would be thrilled if the patient lost weight. Second, lisinopril has only a little negative impact on psoriasis. Because of that, whenever I have a patient like this, I'll ask the general practitioner to switch them to an ARB [angiotensin-receptor blocker] like losartan instead of lisinopril. Third, when I get stuck with a headache patient like this-because of the weight, infliximab takes on some real meaning because you can up the dose. With some of the drugs-certolizumab pegol, adalimumab, you can give the dosing more frequently and get that higher dosing too. You mentioned bimekizumab, which is coming, and JAK inhibitors. Those are all options."

Video • Psoriasis