Has JAK POT Hit the Spot About Infection Risk? Save
Dr. Yuz Yusof discusses abstract OP0092 presented at Eular 2024 in Vienna, Austria.
Transcription
Hello everyone, my name is Youssef. I'm a consultant rheumatologist from Leeds, United Kingdom. I'm reporting for RheumNow, live, from Vienna to cover the EULA twenty twenty four Congress. Today, I would like, to talk about, JAK inhibitor. As we all are aware, JAK inhibition treatment has revolutionized therapy for various, autoimmune rheumatic diseases, including rheumatoid arthritis.
However, this strategy has become under scrutiny, over the last couple of years since the publication of the oral surveillance, clinical trial data. In this oral surveillance data, they found that, there was increased risk of malignancy and also major cardiovascular events, in patients treated with tofacitinib compared to TNF inhibitors. Therefore, the, the regulatory, have issued a warning to be careful in using a JAK inhibitor, particularly in those, above 50 years old of age and also with multiple comorbidities. One other aspect as well is pertaining to infection. The data from the randomised controlled trials as well as the long term extension studies did show some increased risk of opportunistic infection, as well as herpes zoster.
So does this data reflect in the observational study? So Jackpot is one of the largest collaboration of registries which involve 14 registries in the Europe, and also Canada. So in this study, the main aim is, the main aim was to compare, the infection risk, and also herpes zoster risk, between patients treated on JAK inhibitors versus TNF inhibitors, and also versus other mode of action. So other mode of actions include including rituximab, tocilizumab, abataceb, and etcetera. And this presentation, the abstract, number was OP0092.
So, in this study, a large number of patients were involved, were over 50,000 treatment, status, that were analysed. And looking at the key results, there was no, increased risk of any infection or, severe infection between, patients treated with JAK inhibitor versus TNF. Anti serious infection rate, was quoted as nine out of one hundred patient years, whereas TNF is seven out of one hundred patient years. To me, this sounds still a little bit low for a real world, and this sometimes what you might expect with the observational registry data because there potentially could be some reporting bias as well that's not been captured. In terms of other comparison, those treated with other mode of action had a higher rate of any infection and serious infection compared to the TNF inhibitors.
Also, it's important to, let you know, there were some, baseline, characteristic differences, not a lot, but, there were two that I could detect. One were due to the disease duration. So the TNF inhibitors group had much less had less disease duration compared to the TNF and other mode of action. And consequently, terms of biologic naive, so there were more proportion in the TNF group compared to the CHK. So this could potentially also influence the infection outcome.
And another important key here was regarding to the HPZUS rate. And in this real world data, it showed that the incidence ratio were two times more likely in the JAK inhibitor groups compared to the TNF, whereas there was no difference between the other mode of action versus TNF. So what this data showed that in the real world there was no difference in terms of risk of infection, however there was increased risk in terms of herpes zoster and how this may impact our clinical practice. So I think we need to think of some measures to reduce infection rate risk, not just in JAK inhibitors treatment, but also in other biological treatment. We can counsel patients to help with other modifiable risk factors such as to stop smoking and to live an active life and some exercises, but also can also try to help manage their comorbidities better such as diabetes and hypertension, for example.
And importantly, with regards to the zoster risk for the JAK inhibition group, we also want to advocate vaccination, shingles vaccination in order to minimize the risk of activation. And certainly this depends on what has been done in other health care services. For example, in The UK, we can only administer, machine gun vaccination in patients with autoimmune diseases, who are 50 years old or older. So I hope, you found this summary useful, for your clinical practice, and follow me in RheumNow for more coverage of the, Congress content. Bye bye.
However, this strategy has become under scrutiny, over the last couple of years since the publication of the oral surveillance, clinical trial data. In this oral surveillance data, they found that, there was increased risk of malignancy and also major cardiovascular events, in patients treated with tofacitinib compared to TNF inhibitors. Therefore, the, the regulatory, have issued a warning to be careful in using a JAK inhibitor, particularly in those, above 50 years old of age and also with multiple comorbidities. One other aspect as well is pertaining to infection. The data from the randomised controlled trials as well as the long term extension studies did show some increased risk of opportunistic infection, as well as herpes zoster.
So does this data reflect in the observational study? So Jackpot is one of the largest collaboration of registries which involve 14 registries in the Europe, and also Canada. So in this study, the main aim is, the main aim was to compare, the infection risk, and also herpes zoster risk, between patients treated on JAK inhibitors versus TNF inhibitors, and also versus other mode of action. So other mode of actions include including rituximab, tocilizumab, abataceb, and etcetera. And this presentation, the abstract, number was OP0092.
So, in this study, a large number of patients were involved, were over 50,000 treatment, status, that were analysed. And looking at the key results, there was no, increased risk of any infection or, severe infection between, patients treated with JAK inhibitor versus TNF. Anti serious infection rate, was quoted as nine out of one hundred patient years, whereas TNF is seven out of one hundred patient years. To me, this sounds still a little bit low for a real world, and this sometimes what you might expect with the observational registry data because there potentially could be some reporting bias as well that's not been captured. In terms of other comparison, those treated with other mode of action had a higher rate of any infection and serious infection compared to the TNF inhibitors.
Also, it's important to, let you know, there were some, baseline, characteristic differences, not a lot, but, there were two that I could detect. One were due to the disease duration. So the TNF inhibitors group had much less had less disease duration compared to the TNF and other mode of action. And consequently, terms of biologic naive, so there were more proportion in the TNF group compared to the CHK. So this could potentially also influence the infection outcome.
And another important key here was regarding to the HPZUS rate. And in this real world data, it showed that the incidence ratio were two times more likely in the JAK inhibitor groups compared to the TNF, whereas there was no difference between the other mode of action versus TNF. So what this data showed that in the real world there was no difference in terms of risk of infection, however there was increased risk in terms of herpes zoster and how this may impact our clinical practice. So I think we need to think of some measures to reduce infection rate risk, not just in JAK inhibitors treatment, but also in other biological treatment. We can counsel patients to help with other modifiable risk factors such as to stop smoking and to live an active life and some exercises, but also can also try to help manage their comorbidities better such as diabetes and hypertension, for example.
And importantly, with regards to the zoster risk for the JAK inhibition group, we also want to advocate vaccination, shingles vaccination in order to minimize the risk of activation. And certainly this depends on what has been done in other health care services. For example, in The UK, we can only administer, machine gun vaccination in patients with autoimmune diseases, who are 50 years old or older. So I hope, you found this summary useful, for your clinical practice, and follow me in RheumNow for more coverage of the, Congress content. Bye bye.
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