Rheumatology

In analyzing the association between biologic-free remission maintenance and the type of biologic drugs that patients had used, a notable difference emerged between patients who used infliximab, adalimumab, or golimumab versus those who received etanercept and certolizumab pegol.
Full 52-week results of the study, which included a switch from the reference adalimumab to SB5, demonstrate that the biosimilar was well tolerated and that switching led to no change in treatment-emergent adverse events. 
 
Combination treatment is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events with methotrexate that make monotherapy desirable.
Korean drug maker Celltrion has announced that it ready to begin phase 1 and phase 3 clinical trials for CT-P17, a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is used to treat a variety inflammatory diseases. The trials will be conducted simultaneously at 75 sites in 8 nations in the European region including the United Kingdom, and the company indicates that the trials will be completed by 2020.
 
Pfizer’s Ixifi, a biosimilar infliximab product that was approved for all indications of its reference in the United States in December 2017, received FDA clearance with a data package that included findings from a phase 3, randomized, double-blind, active-controlled, multinational study comparing the biosimilar with the reference infliximab in combination with methotrexate in patients with rheumatoid arthritis (RA). The data were presented in an abstract at the American College of Rheumatology’s annual meeting in 2017, and the results for the initial 30-week treatment period have now been published in Arthritis Research and Therapy.
 
The researchers hypothesized that currently used doses of rituximab, of 375 mg/m2 or greater, significantly exceed the half-maximal effective dose of rituximab, at which differences between a biosimilar and the reference would be most likely to be found. 
While data are becoming more numerous on the feasibility of withdrawing a biologic from a patient who has reached low disease activity (LDA) on combination therapy, data concerning the ability to maintain a treatment target on biologic monotherapy are fewer. A new, post-hoc study reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with RA for up to 3 years in more than half of patients who reached LDA after combination therapy.
 
Rituximab, primarily used as a second-line biologic therapy, was used in a cost-saving and adverse-event reducing on-demand schedule in 94.6% of patients; these patients were assessed for signs of relapse and the need for another rituximab infusion at their regularly scheduled visits, and they also had the option of contacting a healthcare provider by phone if they felt that they were relapsing.
Six months after patients switched from reference infliximab to biosimilar infliximab, there was no meaningful increase in patients’ outpatient healthcare use, according to a new study.
In a recent study, only 44.5% of patients with psoriatic arthritis (PsA) persisted with their index biologic for 12 months or more.

Click here to view Biosimilars CME Activities

Click here to view Biosimilars PTCE Activities


Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747
Copyright © 2006-2018 Intellisphere, LLC. All Rights Reserved.