There is increasing evidence to suggest that therapeutic drug monitoring (TDM) will allow for more tailored and rational use of biologics in psoriasis.
There is increasing evidence to suggest that therapeutic drug monitoring (TDM) will allow for more tailored and rational use of biologics in psoriasis, according to a recent study.
For patients with inflammatory bowel disease (IBD) and rheumatoid arthritis (RA), adequate serum concentrations of biologics have been linked with sustainable clinical responses, and now, there is growing evidence to suggest that TDM is beneficial in psoriasis as well.
When it comes to biosimilars, however, there is a lack of data in using TDM. The published TDM data focuses on the use of infliximab biosimilars in IBD and RA, with studies suggesting that biosimilar switching is feasible, with few adverse events.
One study sought to determine if patients with IBD with or without measurable infliximab (Remicade) antibodies for their cross reactivity to the biosimilar Remsima. All 56 patients who tested negative for anti-Remicade antibodies tested negative for antibodies to the biosimilar; all 69 patients who tested positive for anti-Remicade antibodies also tested positive for antibodies to Remsima. In addition, the antibody titres against both the originator and the biosimilar were strongly correlated (P <.001). Similarly, another study reported that 27 patients with varied rheumatological conditions switched from infliximab to a biosimilar and had no significant difference in infliximab serum levels and disease activity for up to 12 months after the switch.
The study proposed a treatment algorithm for TDM of biologics for psoriasis, as there is a need for evidence-based and cost-effective use of biologics, given the high prevalence of psoriasis, the impact on patients’ lives, and the cost of the therapy, the researchers said. Not all patients respond to therapy, or they may stop responding over time, despite the development of medications targeting anti-tumor necrosis factor agents as well as interleukin (IL)-23, IL-22 and IL-17.
The researchers conducted a literature review on the TDM of anti-TNFs (adalimumab, infliximab, and etanercept), IL12/23 antagonists (usekinumab, guselkumab, and tildrakizumab) and IL-17 inhibitors (secukinumab, ikekizumab). While target therapeutic ranges for biologics are preferred, so far this has only been explored in adalimumab, the researchers said.
For adalimumab, the incidence rates of anti-adalimumab antibodies in psoriasis have ranged from 6.5% to 45%. The most recent report of a therapeutic range for adalimumab trough levels range from 3.51-7.00 mg/L.
For etanercept, the researchers wrote that it appears to exhibit immunogenicity less often than other biologics, with anti-etanercept antibodies observed in 0%-18.3% of patients.
For ustekinumab, anti-ustekinumab antibodies (AUA) have been reported in 3.8%-6.0% of patients. In addition, serum ustekinumab concentrations are affected by weight, with lower serum concentrations observed in heavier patients.
The researchers said additional research is needed, especially for newer biologics, to evaluate target therapeutic ranges. For instance, little is known about the TDM of secukinumab and ixekizumab; both selectively bind and neutralize interleukin-17A, the primary effector of Th17 cells. The same is true of guselkumab and tildrakizumab, which target interleukin-23.
While the researchers said they recommend the measurement of biologic serum trial concentrations and anti-drug antibody levels in routine clinical practice when possible, they noted that can be challenging, especially if patients take medication in the office but may skip doses in between visits.
Reference
Liau MM, Oon HH. Therapeutic drug monitoring of biologics and psoriasis (published online July 5, 2019). Biologics. doi: 10.2147/BTT.S188286.
Comparable Disease Activity, Drug Persistence in Patients With JIA Who Switch to Biosimilars
September 12th 2024Switching children with juvenile idiopathic arthritis (JIA) from anti-tumor necrosis factor (TNF) originators to biosimilars showed similar disease activity and drug persistence, with good tolerability, supporting the safety and effectiveness of non-medical switching.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Prioritizing Patient-Centered Care in PsA: Key Insights From the 2023 EULAR Guidelines
August 29th 2024The 2023 European Alliance of Associations for Rheumatology (EULAR) recommendations for psoriatic arthritis (PsA) provide an evidence-based treatment strategy, prioritizing conventional and biological disease-modifying antirheumatic drugs, including biosimilars, tailored to disease manifestations, with an emphasis on safety, cost-effectiveness, and patient-centered care.
Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results
August 21st 2024Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel
August 19th 2024CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.