Maybe this column should be an editorial in Annals. But since I have this platform, I will use it to give my thoughts and not have to go through a peer review process. I am seeing more and more of the pharmaceutical companies whose biologics have been approved for the treatment of asthma talk about clinical remission. I don’t know about you, but when I think about remission of a disease, it means that the disease is gone and there is no need for further treatment. To be sure, I went to the National Cancer Institute of the NIH website and found this definition of remission: “A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body.” The definition doesn’t say all medications have to be stopped and that you are cured of the cancer, so I was not defining the word correctly. Not the first time I have been wrong. Also, they did not use the term “clinical remission,” as I have seen with the asthma biologics.
Next, do other disease states that use biologics talk about “clinical remission?” In fact, they do. For ulcerative colitis, in 2016, the FDA gave guidance to the industry for clinical trials on what needs to be shown to achieve clinical remission. In rheumatoid arthritis, the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) developed criteria for defining remission in that disease. In fact, there are at least two other diseases, Crohn’s and Systemic Lupus Erythematous which have definitions of clinical remission recognized by regulatory authorities and/or international professional organizations.
This leads me to asthma. We always talk about asthma control. Many of us still use the “Rules of Two” in determining if our asthma patients are under optimal control. I have never used remission with a patient, as we know the disease can wax and wane. To look further, I did a PubMed search for “clinical remission in asthma.” This was the first paper to come up: Menzies-Gow A, Bafadhel M, Busse WW, Casale TB, et al. An expert consensus framework for asthma remission as a treatment goal. J Allergy Clin Immunol. 2020 Mar;145(3):757-765. This group used a Delphi survey approach to come up with definitions of clinical and complete remission of asthma. For clinical remission, their consensus findings were “12 or more months with (1) absence of significant symptoms by validated instrument, (2) lung function optimization/ stabilization, (3) patient/provider agreement regarding remission, and (4) no use of systemic corticosteroids.”
I have a couple of issues here – defining lung function optimization and what criteria should be used for patient/provider agreement regarding remission. Is clinical remission in the eye of the beholder? I always try to wean all medications, including biologics, to the lowest dose that controls the disease. Does this mean that I need to wait 12 months to start weaning? Lastly, I have a great deal of respect for many of the authors on this paper, but three of them are employees of a pharmaceutical company that produces a biologic for asthma, and funding for the medical writer came from the same company. That doesn’t mean it is a biased paper, but it does potentially taint the process, in my opinion.
I am open to the need to define clinical remission in asthma, but it needs to be done by the various international allergy and pulmonary professional societies and/or regulatory authorities, and not by pharmaceutical companies. Until then, I will continue to use the word “control” and not “clinical remission” with my asthma patients.