Rheumatology

The researchers concluded that rituximab should be considered as a preferred biologic treatment for rheumatoid arthritis (RA) therapy, though treatment of RA with any biologic medication improved quality of life significantly.

Pfizer’s PF-06410293, a proposed biosimilar adalimumab referencing Humira, shares similar efficacy, safety, and immunogenicity profiles with its reference at 26 weeks of treatment, new research reports.

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.

Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.

Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.

Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.

A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis.

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

In the short term, nonmedical switching (NMS) of stable patients with a rheumatic condition from originator biologics to biosimilars could have “considerable” short-term costs for a rheumatology medical center, according to a study presented at the annual European Congress of Rheumatology.

Research presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology concluded that patients’ attitudes and level of satisfaction with switching to a biosimilar for etanercept or infliximab was associated with their level of health literacy, defined as being given sufficient and necessary information concerning their health.

New International League of Associations for Rheumatology (ILAR) recommendations are now available for the treatment of patients with psoriatic arthritis living in resource-poor regions, including Central and South America and Africa.

The study, conducted in 80 patients with rheumatic diseases who elected to switch from treatment with originator etanercept to biosimilar etanercept, found that 80% were willing to switch, and switching did not affect treatment effectiveness during 1 year of follow up.

Guidelines recommend that disease activity should be assessed every 1 to 3 months in patients with high or moderate disease activity, and every 6 to 12 months in those with low disease activity or remission, but implementation of these principles has not been well evaluated in the United States.

Rituximab has previously been shown to be effective at doses of 1000 mg in treating patients with rheumatoid arthritis (RA) who had previously received other biologic agents. Research presented at the European League Against Rheumatism's Annual European Congress of Rheumatology demonstrates that using lower doses of biosimilar rituximab—which may provide a substantial cost savings—is also effective.

At the European League Against Rheumatism Annual European Congress of Rheumatology, researchers presented findings on 3 studies in which patients switched to a biosimilar etanercept molecule from the reference Enbrel.

This week, the American College of Rheumatology (ACR) released a new position statement on the importance of pharmacovigilance and the critical need to continue monitoring new drugs after they reach the market.

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers presented findings on adalimumab biosimilars, referencing Humira.

At the European League Against Rheumatism (EULAR)'s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers reported on Biocad’s Russian-authorized biosimilar infliximab, BCD-055, and on switches to the widely approved infliximab biosimilar CT-P13 (Inflectra, Remsima).

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, researchers published findings on the economic impacts of nonmedical switching; while 1 study found that switching to biosimilar infliximab brought down costs without sacrificing efficacy or safety, but another raised concerns about increases in overall healthcare utilization.

If European League Against Rheumatism guidelines are followed, when a patient with rheumatoid arthritis (RA) does not reach remission or a state of low disease activity after 6 months of treatment, then the patient’s treatment should be modified regardless of the drug therapy being used (biologic or small molecule).

Two biosimilar developers today announced that they have received positive opinions for products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).