Lupus Foundation of America supported study finds combination therapy that includes hydroxychloroquine may be beneficial to pregnant patients with lupus and/or antiphospholipid syndrome.
Treat-to-Target in Lupus
Treat-to-target is a treatment approach where the physician and the patient agree on certain goals, methods and deadlines for achieving specific outcomes. If the agreed upon treatment strategy does not move toward the goal, the strategy is changed. Treatment goals focus on achieving measurable improvements to the patient’s quality of life.
This concept has been used successfully in other diseases, including rheumatoid arthritis and diabetes. Given its success in improving patients’ health status, a group of lupus experts wanted to determine whether such an approach might be effective in treating lupus.
Beginning in 2012, an international group of lupus experts met several times. The group was composed of specialists in rheumatology (diseases of the joints and muscles), nephrology (diseases of the kidney), dermatology (diseases of the skin), internal medicine (prevention, diagnosis and treatment of adult diseases) and clinical immunology (diseases caused by disorders of the immune system), and a patient representative.
According to Ronald van Vollenhoven, the group's leader and professor of Clinical Therapy Research at the Karolinska Institute in Stockholm, Sweden, “the treat-to-target concept has actually several elements. It has the target, which you decide you want to achieve; how you are going to measure the targets, how you are going to determine that you did in fact achieved it or not; and then the implementation of one or more therapeutic steps that hopefully are going to make it possible to achieve that target.”
Listen to an interview with Dr. van Vollenhoven who explains the treat-to-target approach in lupus.
Using a method that seeks to build consensus, the group developed four overarching principals and 11 specific recommendations for implementing the treat-to-target approach in lupus. The principles and recommendations were published online recently by the journal, Annals of Rheumatic Diseases. The core recommendations focus on targeting remission, preventing damage and improving quality of life.
Dr. van Vollenhoven explained that the goal of using this approach is to improve the patient’s quality of life. “That's the whole idea of treating the patient [making them better], but I do think it makes a difference if you, first of all, identify specific targets, so you're very clear about what you want to achieve. You also identify the correct way of measuring it. You develop a timeline for this, so something can be achieved in a relatively short period of time and other things taken over time. Finally, you also make the agreement with the patient and also with yourself [as the physician], that if you do not achieve this target at the right point in time, then you will do something else.”
Now that the group has developed the principles and recommendations, the next steps in this process are controlled clinical studies to determine whether the treat-to-target approach can be as effective in lupus as it has been in treating rheumatoid arthritis and diabetes. The group felt very strongly that there was sufficient circumstantial evidence to suggest that that is probably the case.
“We are actually already discussing in meetings with international colleagues, the possibility of doing a treat-to-target trial,” said Dr. van Vollenhoven. “Patients will be randomized, of course, after they have been asked for their permission. They will be randomized to treat-to-target based care or getting their care as usual. To make it possible, then we first will have to develop a tool … that will make it possible for the physician to immediately get the feedback on what they are doing with the patient.”
Dr. van Vollenhoven estimates that developing the tool should take about a year. “We're looking at a rather long time line. Reasonably speaking, we could have an instrument for facilitating this within a year and then start the trial maybe in the fall of 2015. Then of course the trial will have to run its course and it usually takes a couple of years. In three to four years, we'll know the answer to this question.”
While the process will take a long time, Dr. van Vollenhoven believes the effort will be worth the investment because of the potential benefits, as demonstrated from the results seen in other diseases. “There are lots of gaps in our data and our knowledge, which will have to be filled, and there is a lot of work that still needs to be done. Every journey starts with the first step, so this is why we are excited about [the concept] because we think we're moving in the right direction.’
Flare rates among participants receiving a low dose of the b-cell blocker did not meet primary endpoint but were lower for individuals receiving a higher dose.