In this particular setting where we compare treat-to-target to usual care, but applied by centers which were experts in axial SpA, so a very good usual care. There was no statistically significant difference, in terms of significant improvement of quality of life after 1 year of intensively targeting disease activity.
However, when we looked at disease activity, other patient reported outcomes, other outcomes that were statistically significant across the groups. And there was also twice as much biologics prescribes in the T2T arm. And curiously, there was no difference in safety. The infection rate was comparable across the groups and, despite this twice as much prescription of biologics, the treat-to-target was proven to be cost effective.
I didn't have the time to go into detail in the presentation, but patients from usual care were actually more on sick leave, compared to patients in the T2T arm so that helped to level the cost of the biologics in the study. So, I think, this study alone cannot justify to apply treat-to-targeting all patients, because despite that, we see many positive outcomes.
The study is negative on its primary end point, but we need other studies-- perhaps more power studies-- to confirm the results that we see in many other outcomes, and in our study. And hopefully we'll confirm our clinical impression that is, the treat-to-target can be applied in patients with axial spondyloarthritis.
There are recommendations available for treat-to-target in axial spondyloarthritis, but there is actually no data proving that such a strategy is efficacious in our patients. The recommendations are somehow driven by the results seen in the TICOSPA trial that control the enteropathic arthritis. And the belief that by targeting inflammation we will improve quality of life of patients, but this is the first study evaluating and comparing T2T, treat-to-target, to usual care.
So for the treat-to-target arm, the predefined strategy that was provided to investigators was provided by an electronic algorithm was simply following the recommendations published by Euller and others, which recommend to start by two full courses of NSAIDs of at least two weeks.
And in case the disease was still active -that was that the ASDAS was not below 2.1- it was recommended to jump up to a biologic. And in case after 12 weeks of treatment there was no improvement whatsoever, and not meeting the target, and below 2.1, then it was recommended to escalate another barrage. Basically, we could resume the treatment, to intensify treatment, up to the point that the target was met, which was an ASDAS below 2.1.
In this study, different from what has been performing rheumatology in treat-to-target, the TICORA and the TICOSPA study aimed to prove an improvement in disease activity by targeting disease activity. And we thought that it would be better to improve health-related quality of life, another domain, a more permanent feature of the disease, while intensively targeting disease activity. And we decided to choose health related quality of life outcome, which is to assess health index, which is a validated index.
And perhaps we were a little bit too ambitious by trying to improve in a relatively short period of time, quality of life, by targeting inflammation that might be one of the reasons. It may be also that the study was slightly under-powered, because of the design of the study, of the cluster-- cluster randomization.
There was no statistically significant difference. We couldn't-- we did not reach the 0.05. But you can see that there was a difference between the two arms in favor of the T2T of 11%. And actually, some studies comparing two active treatment considered, when calculating the sample size, that an 11% difference of course groups could be considered a significant. Potentially these trial will give them a better estimation of the sample size that would be needed.
So perhaps a better study, or more power study, will allow us to draw conclusions. I think we need to do more studies. I cannot believe that with one study, which did not meet the primary outcome, we can say with absolute certainty that T2T must be apply in all patients. But I think it makes sense to have a target in mind when treating a patient with axial spondyloarthritis. And I think it's very important to measure this activity in axial spondyloarthritis.
So tight control is the main limitation, I think. No one in real life-- or almost no one in real life can see patients every four weeks. And in this sense, I think, other health practitioners, such as rheumatology nurses, are key to implement this approach. Otherwise, it's just not possible in clinical practice. Another key role player might be the patient himself or herself. By training patients to self-assess disease activity, we could aim for a tight control in our patients without necessarily having to see them every 4 weeks.