TREATMENT DATABASE
Rituximab (trade names: Rituxan, MabThera) is a monoclonal antibody which acts against the protein CD20. Rituximab was first approved by the FDA in 1997 for the treatment of non-Hodgkin's lymphoma.
All cells have receptors on their surfaces which allow molecules to attach themselves and cause metabolic changes within the cell. One of these receptors, primarily found on the surface of B cells, is called CD20. Molecules that attach to CD20 can affect the growth and development of tumor cells, and, sometimes, cause the production of new tumor cells. Tests confirming the expression of CD20 antigens are important in diagnosing B-cell lymphomas and leukemia.
Rituximab was developed using cloning and recombinant DNA technology from human and murine (mice or rat) genes. It is believed that rituximab destroys tumors by attaching to the CD20 receptor on B cells, causing the tumor cells to disintegrate. In some non-Hodgkin's B-cell lymphomas, rituximab prevents the production of more tumor cells.
Rituximab is also used in the treatment of autoimmune disorders, such as rheumatoid arthritis and Wegener's granulomatosis. In these cases, rituximab works by temporarily depleting the total number of B cells, which are important in promoting inflammation.
USES IN ME/CFS: The effect of rituximab on CFS/ME patients was discovered by accident. Two Norwegian doctors, Øystein Fluge and Olav Mella of Haukeland University Hospital, noticed that after treating a ME/CFS patient for Hodgkin's lymphoma with rituximab, she recovered from ME/CFS. This led the doctors to initiate a small study of rituximab on ME/CFS patients.
Three ME/CFS patients were given rituximab in an open-label trial (that is, the patients knew they were receiving the drug). All three patients experienced significant improvement; two of them responded within six weeks and the third had a delayed response, occurring six months after treatment. The positive effects lasted for between 16 and 44 weeks. After relapse, the patients were administered another dose of rituximab, with the same positive results. The investigators hypothesized that B cells of the immune system might play a significant role in ME/CFS, at least for a subset of patients, and that “CFS may be amenable to therapeutic interventions aimed at modifying B-cell number and function.”
The positive results of this, as well as a second open-label trial, led Drs. Fluge and Mella to conduct a larger study with a more rigorous design to test the effects of the drug. In 2009 they initiated a double-blind, placebo-controlled phase trial with 30 ME/CFS patients. As in the earlier open-label studies, the responses to rituximab were significant. Sustained overall improvements were noted in 67% of the patients (as opposed to 13% of the control group). Four of the rituximab patients showed improvement past the study period. The authors concluded that the delayed responses starting from 2–7 months after rituximab treatment, in spite of rapid B-cell depletion, “suggests that CFS is an autoimmune disease and may be consistent with the gradual elimination of autoantibodies preceding clinical responses.”
In spite of early successes, in 2017 Drs. Fluge and Mella reported that preliminary results from the Phase III trial were negative. This led to a cancellation of the UK trial of rituximab for ME.
| Rating | Side Effects | Reason for Treatment | Dosage / Duration | Age | Sex M/F | # of years Ill | Additional Comments | Illness Severity | Date Added |
|---|---|---|---|---|---|---|---|---|---|
| 5 | B cells depletion brought some disadvantages, despite rigorous hygiene (avoid contact, use hydroalcoholic gel+++, wear a FFp2 mask).I had (reactivated?) Either mycoplasma pneumoniae or chlamydia Pneumoniae, or both (?),during the winter when I was immunocompromised, and sadly, during the 3 months / 3.5 months it took me to completely heal (versus 7/8 weeks for the same infection / pneumopathy without Ritux), I was then returned to the same stage of ME as prior-Ritux. Then immunosuppression led to an episode of oral and vaginal candidiasis. Nothing really bad. The worst side effect for me was a reactional depressive épisode, when in my country they ( internists doctors) refuse to give me some more Rituximab, officialy because its off label for ME/ no published phase III yet. | Hoping healing. It helped a loooot, I went from 5% of my pre-disease capacities to max 40%/ 45% during the 7 weeks that Rituximab helped at its paroxysm (week +33 to week + 39). NB: it helped on ALL the symptoms. Absolutely all. It was miraculous. Unfortunately phase III of RituxME was apparently not conclusive enough ........It helped before and after, of course, but it was progresive | 15 month The same protocole as RituxME Norway's phase II study 1X day | 35 | Female | 9 | You better ask for test prior to Rituximab biotherapy ,by lumbar puncture if you have west nile virus. | Moderate | 12/10/17 |
| 5 | B cells depletion brought some disadvantages, despite rigorous hygiene (avoid contact, use hydroalcoholic gel+++, wear a FFp2 mask).I had (reactivated?) Either mycoplasma pneumoniae or chlamydia Pneumoniae, or both (?),during the winter when I was immunocompromised, and sadly, during the 3 months / 3.5 months it took me to completely heal (versus 7/8 weeks for the same infection / pneumopathy without Ritux), I was then returned to the same stage of ME as prior-Ritux. Then immunosuppression led to an episode of oral and vaginal candidiasis. Nothing really bad. The worst side effect for me was a reactional depressive épisode, when in my country they ( internists doctors) refuse to give me some more Rituximab, officialy because its off label for ME/ no published phase III yet. | Hoping healing. It helped a lot, I went from 5% of my pre-disease capacities to max 40%/ 45% during the 7 weeks that Rituximab helped at its paroxysm (week +33 to week + 39). NB: it helped on ALL the symptoms. Absolutely all. It was miraculous. Unfortunately phase III of RituxME was apparently not conclusive enough ........It helped before and after, of course, but it was progresive | 15 month The same protocol as RituxME Norway's phase II study 1X day | 35 | Female | 9 | You better ask for test prior to Rituximab biotherapy by lumbar puncture if you have West Nile virus. | Moderate | 12/10/17 |
| 2 | None | Lymphoma, though I have CFS | 2 year 1000 mg 6X year | 61 | Female | 37 | I'm on a maintenance dose of Rituxan (no chemo) for Lymphoma, and I was hoping it would help my CFS. Sadly, there has been no improvement in CFS symptoms. | Moderate/Severe | 09/13/19 |