Wednesday, May 24, 2017

What new drugs do we need in Rheumatology?

Sometimes in workshops I have been asked about unmet needs for drugs in rheumatology. At the same time my colleagues and I were looking at new drugs, emerging principles to treat rheumatoid arthritis.
If you look at current pipelines there are several drugs like sarilumab, sirukumab, brodalumab, ixekizumab and biosimilars. We already have five TNF-inhibitors, two JAK- inhibitors, an IL-6-inhibitor, an anti-CD20-agent, a second-signal-inhibitor (CD80 or CD86). Any of these drugs is expensive. Do we need more expensive drugs? Maybe – I won’t rule out that there is a niche for a new principle, but I doubt it. We hear about “promising results” of mavrilimumab (a human monoclonal antibody inhibiting human granulocyte macrophage colony-stimulating factor receptor), but is it coming to the market?

It seems that nobody is working on a drug on the price level of leflunomide. 25 mg of iguratimod (manufactured as Careram by Eisai and as Kolbet by Toyama Kagaku in Japan) [1,2] cost around 1.20-2.40 € per day, which is much less than 52.36 € per day for tofacitinib (Xeljanz) in Germany right now [3].

Iguratimod’s mode of action includes the suppression of NF-κB (nuclear factor kappa-light-chain-enhancer of activated B cells). It hasn’t been tested against tofacitinib or baricitinib. But iguratimod has been tested against and in combination with methotrexate [4]. Z. Xia and colleagues have writte in “Results”: “The combination of iguratimod with MTX was superior to iguratimod or MTX monotherapy”. Too bad, they didn’t comment on MTX vs. iguratimod. The “Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis” is portrait as” “The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years” [5].

Maybe iguratimod isn’t the answer to our unmet needs. But I still hope for some drug to emerge that is cheaper than any of the current monoclonal antibodies or the small molecules that have been approved by FDA or EMA.



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