Bristol-Myers Squibb (BMS) could be adding another drug to its rheumatoid arthritis (RA) franchise after reporting encouraging phase IIb data on clazakizumab this week.
The results of the study found that the anti-interleukin-6 antibody was as effective as AbbVie’s big-selling anti-TNF drug Humira (adalimumab) in patients with moderate to severe RA who had not responded to methotrexate.
Intriguingly though, there was also a suggestion that when both comparator drugs were given alongside methotrexate, there was a non-significant trend towards higher remission rates for clazakizumab. The study was reported this week at the American College of Rheumatology (ACR) meeting in San Diego.
At all doses tested (from 25mg to 200mg subcutaneously once per month), clazakizumab monotherapy and combination treatment was more effective than methotrexate given alone after 12 weeks of treatment in achieving an ACR20, defined as a 20 per cent improvement in symptoms such as tender and swollen joints.
While still very preliminary, the remission data – coupled with results showing that disease activity scores tended to be lower for clazakizumab than Humira – give an early indication BMS could have a strong contender on its hands.
“Currently, less than 30 per cent of RA patients experience sustained remission as defined by ACR criteria,” pointed out musculoskeletal disease specialist and clinical investigator Paul Emery of the Leeds Teaching Hospitals Trust in the UK. “Clazakizumab … provides promising remission data that will need to be further investigated,” he added.
As it affects IL-6, clazakizumab is in roughly the same therapeutic category as Roche’s Actemra (tocilizumab), although its dosing is more favourable as Roche’s drug is currently given as a 60-minute intravenous infusion every four weeks (although a new subcutaneous version allowing dosing every other week has just been approved in the US).
Humira is also given subcutaneously every other week, and leads the RA market with sales of $7.6bn in the first nine months of this year. Meanwhile, Actemra sales have also been growing strongly, thanks to its robust efficacy profile, rising 33 per cent to 733m Swiss francs ($816m) year-to-date.
BMS has exclusive worldwide rights to develop and commercialise clazakizumab for all indications outside of cancer under an agreement with Alder Biopharmaceuticals, which originally developed it.
If it reaches market the drug will slot into the company’s RA portfolio alongside anti-CD80 antibody Orencia (abatacept), which brought in a little over $1bn in the first nine months of 2013.