Cochrane: We examined research published up to January 2014 on the effect of rituximab (Mabthera, Rituxan) for people with rheumatoid arthritis. From eight studies evaluating 2720 people with rheumatoid arthritis, we found that rituximab probably:
- improved pain, function and other symptoms;
- reduced disease activity;
- reduced joint damage as seen on the x-ray.
We often do not have precise information about side effects and
complications. This is particularly true for rare but serious side
effects. Possible side effects are infusion reactions, vascular disorders, and infections.
What is rheumatoid arthritis and what is rituximab?
When you have rheumatoid arthritis,
your immune system, which normally fights infection, attacks the lining
of your joints. This makes your joints swollen, stiff, and painful.
There is no cure for rheumatoid arthritis at present, so the treatments aim to relieve pain and improve your ability to move.
Rituximab works by depleting the levels of B-cells, a type of immune
cell in the body that causes swelling and joint damage in people who
have rheumatoid arthritis. Rituximab is given intravenously. Rituximab is of great interest to rheumatoid arthritis patients based on improvements in symptoms and radiographic progression, and the low rate of short-term side effects.
What happens to people with rheumatoid arthritis who are given rituximab plus methotrexate?
ACR 50 (number of tender or swollen joints, pain, and disability)
- 21 more people out of 100 experienced improvement in their
symptoms after 6 months with rituximab plus methotrexate compared to
methotrexate alone (21% absolute improvement)*.
- 29 people out of 100 experienced improvement with rituximab plus
methotrexate compared to 9 out of 100 who took methotrexate alone.
Disease activity
- 11 more people out of 100 achieved remission of their rheumatoid arthritis after 1 year with rituximab plus methotrexate compared to methotrexate alone (11% absolute improvement).
- 22 people out of 100 on rituximab plus methotrexate achieved remission compared to 11 out of 100 who took methotrexate alone.
Physical function
- 24 more people out of 100 achieved a meaningful improvement in
their physical function after 2 years with rituximab plus methotrexate
compared to methotrexate alone (24% absolute improvement).
- 85 people out of 100 on rituximab plus methotrexate achieved a
meaningful improvement in their physical function compared to 61 out of
100 who took methotrexate alone.
X-rays of the joints
- 19 more people out of 100 had no damage to their joints after 2
years with rituximab plus methotrexate compared to methotrexate alone
(19% absolute improvement)*.
- 57 people out of 100 on rituximab plus methotrexate had no damage
to their joints compared to 39 out of 100 who took methotrexate alone.
Quality of life - physical component (general health, pain, and ability to perform physical activities)
- 34 more people out of 100 perceived their general health, pain, and
ability to perform physical activities better after 6 to 12 months with
rituximab plus methotrexate compared to methotrexate alone (34%
absolute improvement)*.
- 70 people out of 100 who took rituximab plus methotrexate perceived
their general health, pain, and ability to perform physical activities
to be better compared to 36 out of 100 who took methotrexate alone.
Quality of life - mental component
- 13 more people out of 100 perceived their mental well-being better
after 6 to 12 months with rituximab plus methotrexate compared to
methotrexate alone (13% absolute improvement).
- 48 people out of 100 who took rituximab plus methotrexate perceived
their mental well-being to be better compared to 35 out of 100 who took
methotrexate alone.
Discontinuations due to adverse events
- 2 less people out of 100 discontinued rituximab plus methotrexate
due to side effects after 2 years compared to methotrexate alone (-2%
absolute withdrawals).
- 3 people out of 100 who took rituximab plus methotrexate
discontinued methotrexate due to side effects compared to 5 out of 100
who took a placebo.
Serious adverse events
- 4 less people out of 100 experienced serious side effects after 2
years with rituximab plus methotrexate compared to methotrexate alone
(-4% absolute harms).
- 13 people out of 100 who took rituximab plus methotrexate had side
effects compared to 17 out of 100 who took methotrexate alone.
*1% unit difference due to rounding.