UCB Emphasizes Importance Of Patient-Centric Protocols
A conversation with John Ioannou, global medical head of immunology, UCB
Twenty years ago, the waiting room of a rheumatology clinic would have been filled with patients living with severe disability from joint damage. Today’s treatments prevent much of that damage and help patients lead a more normal life, and the very same waiting room would now host patients reflecting just that, explains John Ioannou, looking back on his years as a rheumatologist from the viewpoint of his current position as the global medical head of immunology at UCB.
Yet — and rightly so — he remains less than satisfied with the disease area’s progress in drug development to this point. There is more to do. Still, for many immune-mediated diseases most patients don't achieve full remission, and the goal to have treatments that move beyond symptomatic treatment to provide long periods of drug-free remission, or immune reset, even working toward a cure, remains an aspirational one.
In the following Q&A, Ioannou emphasizes the need to partner with the healthcare community, supporting medical and patient organizations, but most importantly, patients themselves to advance drug development, the standard of care, and the design and execution of patient-centric clinical trials.
Clinical Leader: Tell us about your background and work in clinical trials.
Before joining UCB, I was a clinical academic in rheumatology for over 20 years, thus recognizing the importance of creating strong partnerships between academia and industry to drive patient-centric clinical studies. I see my current role at UCB as partnering with the scientific, clinical, and patient communities — to bring together the voices of these stakeholders for all the relevant teams within UCB developing solutions to address ongoing unmet needs for people living with severe immune-mediated diseases. One of the most important teams is the clinical development trial team as they are generating data that is relevant for patients and the medical community. Ultimately, we are working toward the goal of elevating the standards of care to ultimately improve outcomes for patients. To do that, we develop a deep understanding of the needs of patients, the clinical community, and the scientific community, and identify the evidence gaps to address those needs. This comes from developing different types of partnerships.
Let's talk a bit about those partnerships, who you partner with and why.
I would classify partnerships into five broad buckets. We have several academic collaborative partnerships both in Europe and the US. We have public-private partnerships, where we're part of a larger consortium that enables experts to get together to address big research questions such as speeding up the diagnosis or developing precision medicine strategies for diseases. We also partner with medical societies that focus on setting the standard of care and building the scientific community of tomorrow, through career development for young academics. We partner with research funding bodies. And very importantly. we partner with patient organizations and with individual patients. These patient partnerships are critical to develop those deep insights into their lives, into the disease that impacts their lives, and into what matters to them.
Partnership with patients is not just about engagement; it's also about co-creating with them. We don't just develop something and go to patients and say, “What do you think of this?” We involve patients very early on in the co-creation, for example as part of protocol development to understand their needs.
We ask ourselves questions such as: “What are the outcomes that are relevant for patients? Are we measuring them in the right way? Is the trial design patient-friendly? Are there too many visits? Are the visits too long? How can patients travel to the centers? Can we do something digitally, or can we arrange home visits? Are the consent forms patient-friendly and written in a language that's accessible to patients?”
Co-creation with the patient leads to a patient-centric trial design that has been proven to develop data that's more relevant for patients. It improves recruitment. It improves retention and improves not only the speed with which the data is generated but also its quality. You have fewer missed visits, so you've got less missing data, and thus data is generated more quickly. It benefits everybody.
Was there anything that affirmed what you already knew about patient preferences? Or was there anything that maybe surprised you?
In my academic life, I do recall a conversation with a patient that made a big difference. I was struggling with recruiting for a university-led clinical study. The patient said to me, “Well, you know, there's no parking near the hospital.” All it took was making a small tweak to ensure that patients had a car park space or there was a taxi provided, and these small tweaks made a big difference with better recruitment and fewer missed visits. As an academic, I was more focussed on the science. I just didn't think that these logistical things were so important.
It's also worth looking at the study and deciding whether we can get some of this data from a telephone conversation or some kind of digital method or even a nurse at their house to collect basic vital signs. They may not need to come to the hospital for all the visits. And it's those simple things, those small investment tweaks, that can lead to large savings in the longer term and really make a big difference.
You've got all this great feedback from your patients to design your trials better. Was there ever a time when you had a partnership that didn't go as smoothly?
Maybe 10 years ago or so, there was less of a tendency to co-create with patients. It was more tempting to build the protocol and then go to patients to see what they think. But then you ran into recruitment problems. Patients were just not engaging with it. And they fell off the study. They didn’t attend the visits. I can think of two or three examples where that's happened, where the studies had gone on far longer than we would have liked.
Another piece is having a deep understanding of the patient's needs and developing outcome measures that are relevant for them. For example, systemic lupus erythematosus (SLE) is a disease that can affect young women and cause quite a high degree of morbidity and even mortality. A symptom that can negatively impact the quality of life of people living with lupus is severe fatigue.
When I was a clinical academic at University College London, my then boss, Professor David Isenberg, asked around 400 patients “If there was one thing we could make better for you, what would you choose?” and the response surprised me. They didn't say “Make my kidneys better” or “Make my rash go away” or “Make my joints better.” They wanted to get rid of their fatigue. It's an intense disabling fatigue, not only physical but also mental and cognitive fatigue, which is characteristic of the overall fatigue people with SLE experience. The tools to measure fatigue had been inadequate because they were not disease-specific. Hence, we developed a SLE-specific fatigue outcome measure tool, called Fatigue PRO, in partnership with patients and lupus specialists together.
It’s one of the achievements I'm most proud of at UCB. It's something that really matters for patients, and we developed a fit-for-purpose tool to measure that particular issue for them.
Speaking of women, specifically those of childbearing age, they're considered underserved in clinical research, including trials for chronic rheumatic diseases (CRDs). How do you make this a priority — to include them and to do so safely?
Unless there's evidence to demonstrate safety during pregnancy or lactation, mothers understandably often take a cautious approach. And without the data, tend to have a greater tendency to discontinue medication and this may then risk their disease flaring. And we know that having prolonged and severe inflammation in the body through any cause during pregnancy can cause adverse outcomes for pregnancies. In many immune-mediated inflammatory diseases like SLE for example, there is often a need to control inflammation with steroids, and steroids themselves are associated with adverse outcomes during pregnancy.
Healthcare providers and women who do become pregnant and/or are lactating need data upon which to base informed decisions. We recognize this better now. We have undertaken studies to understand whether the relevant antibody treatment, also known as a biologic, would cross the placenta and whether there would be any transfer in breast milk. Hence data was generated to allow the healthcare and patient community to make more informed choices around their treatment. These are not easy studies to do but are important and we now take a more proactive approach to generating this relevant data for women of childbearing age earlier in programs than was previously more the norm.
About The Expert:
John Ioannou qualified at the Royal London Hospital in 1994 and trained in rheumatology. As a clinical academic at University College London from 2007-17, he built up a large research group in the area of lupus and adolescent/young adult rheumatology. He has published over 100 peer-reviewed papers, has been an associate editor for numerous journals, sat on multiple grant committees, and was awarded the UK’s Michael Mason BSR Gold Medal in 2011. He joined UCB in April 2017, initially in research and development, and then progressed through various global medical affairs leadership roles. He is currently the global medical head of immunology therapeutic area at UCB.