Relapses in People With Multiple Sclerosis Treated With Cladribine Tablets Followed for Up to 5 Years: A Plain Language Summary

Abstract

What is this summary about?

This is a summary of an article originally published in the Multiple Sclerosis Journal. The article presents the results from the CLARITY and CLARITY Extension studies, which looked at how well cladribine tablets work in treating people with multiple sclerosis (shortened to MS). Cladribine tablets are a medication approved for treating relapsing forms of MS. This study looked at how treatment with cladribine tablets affects the frequency and severity of relapses in people with MS. A relapse is when new symptoms develop or old symptoms return or get worse after a period of stability or improvement.

What happened in the studies?

In the CLARITY study, 870 people received either cladribine tablets (3.5 mg/kg, the approved dose) or placebo (a dummy pill). After the CLARITY study ended, some participants who received cladribine tablets chose to take part in a second study called the CLARITY Extension study. Of these participants, 98 were given placebo for 2 more years following an interval period of up to 10 months between participating in each study.

What were the results?

People with MS who were treated with cladribine tablets for 2 years in the CLARITY study had lower risks of any relapse compared with those given placebo. Participants taking placebo (after cladribine tablets) in the CLARITY Extension study experienced these same benefits, which continued for up to 3 more years after having received cladribine tablets in the CLARITY study.

What do the results mean?

Researchers concluded the recommended 2-year dosing of cladribine tablets may reduce the number and severity of relapses in people with MS for up to 5 years.

Clinical Trial Registration: NCT00213135 (ClinicalTrials.gov)

Clinical Trial Registration: NCT00641537 (ClinicalTrials.gov)

To read the full Plain Language Summary of this article, click here to view the PDF.

Link to original article here

Keywords:

• cladribine tablets
• CLARITY
• CLARITY Extension
• lay summary
• multiple sclerosis
• plain language summary
• relapse

Acknowledgements

The authors would like to thank everyone who took part in the CLARITY or CLARITY Extension studies.

Financial & competing interests disclosure

Plain language summary writing and editorial support was provided by Jenna Steere, PhD, Rebecca Harris, PhD, Dena McWain, Martin Edwards, and Delisa O’Brien of Ashfield MedComms (New York, NY, USA), an Inizio company, and was funded by EMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA. The authors had full control of this summary and provided their final approval of all content. Full author disclosure information for the authors can be found in the original article.