The following is a summary of the “Expert opinion on the long-term use of cladribine tablets for multiple sclerosis: Systematic literature review of real-world evidence,” published in the January 2023 issue of Multiple Sclerosis and Related Disorders by Guevera, et al.
Relapsing multiple sclerosis (RMS) patients treated with cladribine tablets (CladT), an immune reconstitution therapy, undergo two brief treatment cycles in years 1 and 2. Most CladT patients find long-term success. However, some may develop illness relapse (DA). The long-term care of these individuals may raise questions for doctors after they have been given the prescribed dose. Real-world evidence (RWE) has been growing since the EU approved CladT more than 5 years ago, and it may offer some insights and recommendations for therapeutic practice. Here, we present the results of a Study of RWE and experts’ opinions on six questions concerning the long-term application of CladT.
A steering group (SC) of 14 international MS experts developed pertinent clinical issues about breakthrough DA in Year 1, new DA after 2 years of treatment, long-term management of stable patients, and whether or not more rounds of CladT may be required or safe.
They conducted a systematic literature review (SLR) in EMBASE and PubMed using the population, intervention, comparators, outcomes, and study design (PICOS) framework to find publications relevant to our topic area published within the last 15 years. They also reviewed the proceedings of the most important conferences during the past 2 or 3 years. Having reviewed the findings and RWE, the SC developed and reached a consensus on expert opinion statements for each inquiry. This review includes 35 papers that present RWE for CladT. In the actual world, patients transitioning from anti-lymphocyte trafficking drugs are more likely to experience breakthrough DA in Year 1. This DA did not result in therapy withdrawal in most individuals. After the therapeutic benefit of CladT has been established (at the end of Year 2, 3, or 4), the reported rates of DA range from 12.0 to 18.7%, according to the few studies that were able to be located. For patients who are stable by Year 5, no RWE was found to support management recommendations.
The group’s opinions were split on this issue, too, so members had to cast ballots on the statements made by the experts. Just two studies mentioned using CladT beyond the initial course. However, they didn’t publish any safety data. There is growing robust evidence (RWE) for using CladT long-term in treating RMS; however, there are still knowledge gaps. Wherever possible, the SLR-identified RWE was used to develop expert comments; however, in areas where RWE is still scarce, statements were instead based entirely on experiences and opinions to provide some direction on subjects and questions that arise in everyday clinical practice. Additional field-based research with extended follow-up times is urgently required and eagerly anticipated.
Source: sciencedirect.com/science/article/pii/S2211034822009634