A study1 has shown that rheumatoid arthritis patients given multiple courses
of MabThera experienced further improvements in their condition with each
subsequent treatment course. The patients in the study all suffered from
moderate to severe rheumatoid arthritis (RA) and had failed to respond
adequately to another class of RA drug known as tumour necrosis factor (TNF)
inhibitors, the most commonly prescribed first-line biologic therapy for RA.
The continued response seen with MabThera is a particularly important
outcome as it highlights durable efficacy over time.
The impressive new data presented at the American College of Rheumatology
(ACR) annual meeting in San Francisco show that MabThera continues to
improve RA symptoms with each subsequent course of treatment, maximising
patient response. The number of patients achieving remission from their
disease doubled over three successive treatment courses with MabThera
(Disease Activity Scores (DAS)[*] increased from 8.8% after the first course
to 17.6% after the third course). Additionally, almost twice as many
patients achieved a 70% reduction of their symptoms after their third course
of treatment compared to their first course of treatment (increase in
ACR70[†] response from 14% to 25.7%).
“Prolonged treatment with MabThera clearly demonstrates an improvement in
symptoms for patients with rheumatoid arthritis who do not respond
adequately to TNF inhibitor therapy,” said Professor Edward Keystone,
Rheumatology Department at the University of Toronto, Canada. “These
findings confirm that MabThera controls rheumatoid arthritis effectively,
giving patients greater freedom from the disease with repeat courses of
treatment.”
Long-term treatment with MabThera also shown to reduce joint damage
MabThera's effectiveness over the long term is reinforced by further data
presented at ACR which demonstrate that the drug continues to significantly
inhibit the progression of joint damage caused by RA over a period of two
years in those patients who do not respond to TNF inhibitor therapy2. Damage
to the structure of joints ultimately causes joint destruction and
contributes to joint deformity and loss of mobility. The inhibition of
structural damage is therefore a major goal of treatment. In patients who do
not respond to TNF inhibitor therapy, MabThera is the first and only therapy
to have demonstrated a reduction in joint structural damage.
Data demonstrates long-term safety of MabThera
Six-year follow-up data also presented at the ACR prove that MabThera
continues to be well-tolerated over several courses of treatment. The safety
profile of MabThera remained consistent with a low rate of adverse events
and infections in 2578 patients, receiving multiple treatment courses. These
results add to the wealth of data contributing to MabThera's safety profile
with 5013 patient-years of follow-up now collected.3
Commenting on the findings, Dr Ronald van Vollenhoven, Rheumatology Unit at
Karolinska University Hospital, Sweden, said, “This data confirms that the
excellent safety profile identified with MabThera in clinical trials after
one course of therapy is maintained over multiple courses. This is very
reassuring for physicians. Given that rheumatoid arthritis is a long-term
condition, we want to ensure that treatments for patients are both effective
and safe over an extended period of time.”
1 Keystone, EC et al. Efficacy and safety of repeat treatment courses of
rituximab (RTX) in RA patients with inadequate response to tumor necrosis
factor inhibitors: long-term experience from the REFLEX study. ACR 2008. 2
Cohen S et al. Continued inhibition of structural damage in RA patients
treated with rituximab at two years: REFLEX study. ACR, 2008. 3 van
Vollenhoven, RF et al. Long-term safety of rituximab: 6-year follow-up of
the RA clinical trials and re-treatment population. ACR 2008.
