Two biologics that work on psoriatic disease differently – Cosentyx (drug name secukinumab, an IL-17a inhibitor) and Humira (drug name adalimumab, a TNF-alpha inhibitor) – were recently tested in a study designed and funded by Novartis, the company behind Cosentyx.
The study pitted Cosentyx against Humira for 52 weeks in adults with active psoriatic arthritis who were new to biologic treatments. The key measurement used was ACR20, which looks for a 20% improvement in a combination of psoriatic arthritis factors, comparing each patient’s status at the end of the study to how it rated at the beginning. The factors include tender or swollen joint counts as well as body-wide assessments of disease activity. The measurement is not focused on skin symptoms.
Neither the physicians nor the patients were told which treatment each patient was receiving. Both treatments consist of periodic injections under the skin. The study results were published in the Lancet medical journal, with some world-renowned psoriasis experts as coauthors.
A statistical tie.
On the ACR20 measure, Cosentyx did not prove superiority as Novartis had hoped. Humira has long been a gold standard in several immune system diseases – including psoriasis and psoriatic arthritis – so a tie is nothing to sneeze at.
Cosentyx came away with some other bragging rights. Notably, it bested Humira in PASI 90 response, which reflects a 90% improvement in a combination of psoriasis skin symptoms. After one year, 67% of Cosentyx patients had achieved a PASI 90 improvement, versus 43% of Humira patients.
A higher percentage of Cosentyx patients also made it through the entire 52 weeks of the study: 24% of Humira patients discontinued their participation, versus 14% of Cosentyx patients. The three primary reasons cited for discontinuations of either treatment were nearly half due to “patient or guardian decision,” nearly one-quarter due to adverse events, and nearly one-quarter due to the treatment not working well enough. (If we can learn more about reasons that typically drive a “patient or guardian decision” to leave a study, we will update this article with that information.)
Humira remains in a strong position. It has been used by thousands of physicians and millions of patients worldwide for a variety of immune-mediated diseases, and has been US FDA-approved for psoriatic arthritis for 15 years. Its safety record is well-established.
Cosentyx, meanwhile, receives additional confirmation about the excellent skin clearance it provides in psoriasis and psoriatic arthritis, while matching Humira for improvement in the musculo-skeletal elements of psoriatic arthritis – the joint pain and swollen or tender joints.
A couple of notes on limitations of the study. First, it restricted other treatments that could be used along with the study treatments; while in actual practice, methotrexate is commonly used with biologics for psoriatic arthritis.
In addition, the study did not look at “inhibition of radiographic progression,” which measures how much damage psoriatic arthritis has done to joints and bones, as seen in X-rays. The FDA has previously confirmed that both Humira and Cosentyx have demonstrated the ability to slow the progression of joint structural damage from psoriatic arthritis, but this head-to-head study did not compare the two on that factor.
From the patient perspective, the study is good news, since the two treatments both work well, but differently, to improve psoriatic disease. Some who don’t do well on one of them might still get great relief from the other.
More and more of these head-to-head studies are being done now, as companies try to differentiate their treatment from the others. This can be helpful for patients and physicians, and we will be reporting on many of them in the weeks ahead.
[Last updated: 5/14/2020]