New rheumatoid arthritis treatments show promise
Rheumatoid arthritis improved with two new investigational drugs |
Two investigational drugs for rheumatoid arthritis — tocilizumab and certolizumab pegol — have shown promise in Phase III studies, data from which were presented at the Annual
European Congress of Rheumatology, held last month in Barcelona.
Investigators randomised 623 patients with moderate to severe rheumatoid
arthritis to receive tocilizumab — a novel monoclonal antibody
targeting interleukin-6 signalling developed by Roche — at a dose
of 8mg/kg or 4mg/kg, or placebo every four weeks. All patients continued
receiving methotrexate at their usual dose throughout the study.
More patients receiving tocilizumab achieved a 20 per cent improvement
according to the American College of Rheumatology Criteria (ACR20 response)
at 24 weeks than those given placebo (8mg/kg 58.5 per cent, 4mg/kg 47.9
per cent, compared with placebo 26.5 per cent; P<0.0001 for
both comparisons).
More patients receiving tocilizumab 8mg/kg achieved
50 per cent improvement (ACR50; 43.9 per cent) and 70 per cent improvement
(ACR70; 22.0 per cent)
than patients given placebo (10.8 per cent and 2.0 per cent, respectively; P<0.0001 for both comparisons).
The researchers reported that tocilizumab treatment led to statistically
significant and clinically meaningful improvements in both health-related
quality of life and physical function scores for rheumatoid arthritis
patients.
The overall frequency of adverse events was similar in all three groups,
the researchers state. Serious infections were reported in six patients
in the tocilizumab 8mg/kg group, three patients in the 4mg/kg group and
two patients in the placebo group (no P-values were presented).
In Phase III studies of certolizumab pegol — a pegylated anti-tumour
necrosis factor drug developed by UCB — more patients in the certolizumab
treatment groups (400mg on weeks 0, 2 and 4 followed by 200mg every two
weeks plus methotrexate; or 400mg every two weeks plus methotrexate)
achieved ACR20, ACR50 and ACR70 responses at 24 weeks than those assigned
to placebo plus methotrexate (P<0.001 for each). Another study presented
at the conference showed certolizumab given every four weeks as monotherapy
to be more effective than placebo.
Certolizumab lacks the “Fc region” found in other anti-TNF
drugs, which is believed to be associated with cytotoxicity rather than
efficacy. |
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Pharmaceutical Journal
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