UCB has presented new data on its biologic Cimzia showing that the drug is proving to be effective in 'real life' patients suffering from rheumatoid arthritis.
Phase IIIb data has been presented at the American College of Rheumatology meeting in Atlanta which show Cimzia (certolizumab pegol) performed as well in a large ‘real-life’ population of rheumatoid arthritis patients as it did in the rarefied setting of earlier pivotal clinical trials where patient entry criteria are strictly controlled.
In the new trial, called REALISTIC, 1,063 patients with active RA, typical of those seen in routine clinical practice, were randomised in a 12-week double-blind study to take either Cimzia, the only pegylated anti-tumor necrosis factor therapy on the market, or placebo in addition to their usual treatment before entering a 16-week open-label extension. These patients were included regardless of how long they had suffered with RA or of their exposure to up to two other anti-TNF drugs, to methotrexate or to prior use of disease-modifying drugs where they had seen no or limited response. In the pivotal trials patients usually have a limited history of RA disease and no prior exposure to anti-TNF drugs at all.
By the end of 12 weeks, twice the percentage of Cimzia-allocated patients achieved the primary outcome measure of ACR20 as the control group (51.1% vs 25.9%). Patients receiving Cimzia experienced a rapid clinical response, had superior ACR50/70 responses and superior results on other outcomes (DAS28 disease activity score and Health Assessment Questionnaire-Disability Index measuring physical function).
Responses were very significantly superior on the ACR20 measure from week 2 (31.8% vs 8.5%). For the ACR50 measure at week 2, results were 9.6% vs 1.4%). Results on the other measures were also rapid and significant.
When results were compared for patients with and without prior methotrexate or anti-TNF drugs, results were still superior for patients receiving active treatment with more than three times the percentage experiencing ACR20/50 responses compared to those getting placebo (26% and 13% vs 9.9% and 2.8% respectively.)
Commenting on the data, Roy Fleischmann of University of Texas, one of the lead investigators, said the study results overturned some common misconceptions: “Before this study clinicians would have thought the chances of a patient responding well to this biologic drug would be slim if they hadn’t responded to anti-TNF drugs before. So the good results we saw were one very interesting outcome.”
The other perception-busting finding was the belief that patients with early disease would be much more likely to respond exceptionally well than patients with long-standing disease and prior treatment with multiple therapies, or long exposure to methotrexate, Dr Fleischmann said. “That wasn’t true. Patients had just as good and fast a response if they had lived with the disease a long time as those more recently diagnosed.”
This opens the question as to how much of a window of opportunity to treat exists. “We know the earlier that patients are treated effectively will mean they experience less joint damage. But the question remained as to whether or not patients would respond as well if they got effective treatment later than if they got it earlier. This study tells us the answer is yes, if they are responders, they will respond regardless of their disease history,” he added.
UCB chief executive Roch Doliveux noted that “Cimzia has some unique features in design that sets it apart from other anti-TNF agents", ie it is pegylated and is a fragmented antibody. He added that “one of the big changes in rheumatology is a better understanding that getting a response early matters. It lessens patients’ chances of becoming disabled.”
This is now enshrined in new European League Against Rheumatism (EULAR) treatment guidelines, Mr Doliveux noted. Cimzia’s demonstrated ability to act very quickly with patients experiencing a response from a week onwards and results evident within 12 weeks puts it in a good position that clinicians are increasingly recognising. The product is gaining market share each month, he disclosed.