From the CEO’s Desk: November 2011
By K. Kimberly McCleary
A patient receiving her infusion is kept company by a study nurse and Drs. Mella and Fluge (far right)
On Oct. 19, 2011, a team of researchers in Norway, led by Drs. Olav Mella and Øystein Fluge at Haukeland University Hospital, published promising results of a small phase II clinical trial of rituximab (Rituxan) in CFS patients. Although it involved just 30 patients, the study was double-blinded and placebo-controlled, the most rigorous kind of clinical trial designed to reduce the potential bias of the investigators and the subjects involved. After two infusions of rituximab (a monoclonal antibody FDA-approved for two forms of cancer and rheumatoid arthritis), 67 percent of subjects in the treatment arm experienced significant improvement in all CFS symptoms. Just 12 percent of the placebo-treated patients benefitted. (For more details, please read our summary of the study and links to media coverage: http://bit.ly/oPSwTo.)
The researchers are following up these encouraging results with two open-label studies in hopes of improving the protocol for administration and dosing of the agent. There has been tremendous interest from researchers and physicians in the U.S., U.K., Spain and other countries to initiate other studies, although we don’t have any specific news to share yet. Some people were surprised that this type of treatment would be applied to CFS, but there are plausible mechanisms (in at least a subset of patients) for its success found in published studies of immune abnormalities in CFS going back to the early 1990s. The study authors have responded to a letter to the PLoS ONE editor, providing an interesting exchange of ideas about the mechanism of action that might be at work. (See http://bit.ly/sgutnc.) We’ve posted systems biologist Dr. Gordon Broderick’s observations about rituximab’s early success here: http://bit.ly/oQk7dw.
Dr. John Sweetenham
Rituximab is approved to treat five conditions and it has been tested in a wide variety of cancers and inflammatory and autoimmune disorders. Oncologist Dr. John Sweetenham of the Cleveland Clinic answered some of the basic questions about rituximab here: http://bit.ly/sQtJdc. We addressed several additional questions in the comments on that post and the others linked here.
It is “early days,” as they say, and there is much to learn about the use of this novel therapy in CFS. It is very encouraging to hear the stories of patients who have benefited from the trial and to see the response from the authorities in Norway, including an apology from the Norwegian Directorate of Health to ME/CFS patients who have received inadequate care in their national health system. (Our story about TV2 news coverage in Norway: http://bit.ly/ol8JAR.) Drs. Fluge and Mella have also reported that there is now a national effort to conduct a larger, multicenter phase III study, but they caution it will take some time to plan and get necessary approvals. We’ll host a Q&A with them later this month (after they’ve had some time to breathe!). The doctors have stated in several interviews that use of rituximab in CFS should, for now, be restricted to research studies.
We see these study results as a new lever in our efforts to mobilize resources that will advance objective diagnosis and effective treatment. It’s important that this lead is followed and that other promising research continues as well. We have 26 grant applications for exciting new research projects now under review for scientific and strategic merit. Our SolveCFS BioBank and the biomarker “hit” list we’re working to develop will be even more valuable resources for the field in light of recent publications. We’ll post updates from our funded investigators and about other aspects of our research program later this month. In the meantime, please consider becoming a catalyst for research with a gift of any amount to the Catalyst Fund. Contributions of up to $10,000 each will be matched through year-end and will support the next round of research grants and other exciting work being led by the Association. In return, you’ll receive access to exclusive Catalyst updates and events. You can make an online donation at our secure page: http://bit.ly/2011fund.
The Saturday Evening Post recently interviewed Suzanne Vernon, our scientific director, and the interview is now posted on the magazine’s website; a second part will run in the November/December print edition’s “Medical Mailbox” feature. Media coverage about other research-focused topics continues almost daily; we regularly update the detailed listing here on Research1st.
K. Kimberly McCleary has been the Solve ME/CFS Initiative ’s chief staff executive since 1991November 3, 2011