What was the ORAL Surveillance study, and how does it relate to the labeling language of Olumiant?
Mount Sinai Ichan School of Medicine
New York, NY
So having a comprehensive understanding of ORAL surveillance really is critical if you're going to be a dermatology provider at this point in time, just because we're going to continue to get more and more JAK inhibitors approved. ORAL surveillance was a study for the original JAK inhibitor, tofacitinib, which was in the rheumatoid arthritis population. It was a enriched for high risk patient study, it was a safety study. Patients had to be over the age of 50, they had to have at least one cardiovascular risk factor. Every single one of these RA patients was on a methotrexate with a median dose of 17 milligrams and 60% were on chronic prednisone. That's a ton of data I just dropped, but it's important that you understand how high risk these patients are. Think about how different that type of patient is compared to your 16 year old or your 20 year old with alopecia areata, for example, that usually is quite healthy. And so because of that, we're seeing such different safety with our JAK inhibitors and dermatology than they were with tofacitinib in that RA population. But unfortunately we're still stuck with that boxed warning language from the tofacitinib study ORAL surveillance, but you need to have that contextualization to understand why you can safely use JAK inhibitors in dermatology.
In this video, Dr. Michael Cameron discusses the ORAL Surveillance study and its relevance to the labeling language of the drug Olumiant (baricitinib), particularly in dermatology practice.
The ORAL Surveillance study was conducted to evaluate the safety of the JAK inhibitor tofacitinib in the rheumatoid arthritis (RA) population. The study specifically targeted high-risk patients, who were over the age of 50 and had at least one cardiovascular risk factor. All the RA patients in the study were also on methotrexate, with a median dose of 17 milligrams, and 60% of them were on chronic prednisone. This means the patients in this study were at a significantly higher risk compared to younger, healthier patients typically seen in dermatology, such as those with alopecia areata.
Dr. Cameron emphasizes the importance of understanding the context and differences in patient populations when considering the safety of JAK inhibitors in dermatology. While the ORAL Surveillance study provided crucial safety data for tofacitinib in RA patients, the risks and safety profile may differ in dermatology patients who do not share the same high-risk characteristics.
Despite this difference in patient populations, the labeling language of Olumiant, which is based on the ORAL Surveillance study, includes a boxed warning. Dr. Cameron points out that dermatology providers should be aware of the ORAL Surveillance study's context and the higher-risk profile of the RA patients involved. By understanding these distinctions, healthcare professionals can confidently and safely use JAK inhibitors in dermatology patients, even if the boxed warning is still present in the drug's labeling language.
- The ORAL Surveillance study focused on the JAK inhibitor tofacitinib in the rheumatoid arthritis (RA) population.
- The study included high-risk patients who were over 50 years old and had at least one cardiovascular risk factor.
- All RA patients in the study were on methotrexate with a median dose of 17 milligrams, and 60% were on chronic prednisone.
- The patient population in the study was markedly different from younger and healthier patients with conditions like alopecia areata.
- The safety profile of JAK inhibitors in dermatology is different from that observed in the RA population in the ORAL Surveillance study.
- Despite the differences in safety, the boxed warning language from the ORAL Surveillance study still applies to JAK inhibitors.
- Contextual understanding is necessary to ensure the safe use of JAK inhibitors in dermatology.