Highlights

I think we’ve seen it with most therapies that some patients respond initially but don’t have a durable response and then eventually come to surgery because of that. What we’ve also seen is that all the drugs we’ve got, there seems to be like a ceiling of achieving remission in probably 15–25% at a push, and a maintained response in about 50–55%, but there doesn’t seem to be any drug that achieves, in the clinical trials, a response anywhere in the range of 80–90% clinical remission in half of the patients. What we’re really hoping for, and I don’t think it’s around the corner unfortunately, is a drug which really gets the majority of patients into remission and response rather than just a fraction. I think that’s the biggest disappointment at the moment when we look at new data coming through. And then ideally we would have, and this is the Holy Grail, a risk stratification tool that tells us which drug is the right drug for a patient, which drug are they most likely to respond to. Because at the moment you sequence them either by cost, by safety, by efficacy, or pretty randomly, but we don’t have a way of saying, actually, patient A, having looked at all his markers, will likely respond to infliximab best, and patient B to vedolizumab, and patient C should go onto tofacitinib first line. If we had a way of approaching that a little bit more rationally and a little bit more individualized, that would really be fantastic. But I think a lot of people have looked into developing the right biomarkers and so far there’s relatively little success.

I think, in terms of safety from the published clinical trial data, the whole class, not just mirikizumab but also risankizumab and guselkumab, they look good from a safety profile. I think that’s all been reassuring. There’s not been very much reported in any of the trials that makes me concerned that they are an agent that has got a worse safety profile than established biologics, and may indeed have a slightly more benign profile. In terms of efficacy data for ulcerative colitis, they look good. Do they look miraculous – I don’t think so? Are they potentially better than ustekinumab, because they are similar but not the same method of action – I’m not sure how comparable they are, but my feeling is that they’re probably slightly more efficacious, but I would say that in Crohn’s disease with a lot more confidence than in ulcerative colitis. But I think they will be a challenger to ustekinumab, the only trouble is that ustekinumab will come off patent in two to three years from now, I think, and, as ustekinumab is a multi-disease drug, I assume there will be quite a few biosimilars. And what we’ve seen in the UK with biosimilars is that the price is really reduced drastically, so I think the prices for ustekinumab in two to three years’ time will be a fraction of what they are now. If it’s anything to go by what we’ve seen with TNFs, then somewhere in the range of 15–30% of what the cost is now. It will be very hard on a price basis to compete for an originator biologic if they’re priced anything like they have been priced in the past.