Transitioning Between Brodalumab and Secukinumab in Moderate to Severe Psoriasis: An Early Look
August 2016 | Volume 15 | Issue 8 | Original Article | 941 | Copyright © August 2016
Ronald B. Vender MD FRCPC
Director Dermatrials Research Inc., Hamilton, ON, Canada; Venderm Innovations in Psoriasis, Hamilton, ON, Canada
BACKGROUND: Biologics have changed the way we treat moderate to severe psoriasis. Clinical trials for these patients offer the chance for those suffering from psoriasis to volunteer their time for the advancement of science while possibly gaining benefit from the efficacy of these medications.
OBJECTIVE: All clinical trials have an ending by study design. In the past, trials ended abruptly but it is more common now for transitioning to the approved or another biologic to be offered. Sometimes, study subjects leave clinical trials suddenly for reasons of lack of efficacy, safety, withdrawing consent, being lost to follow-up, or personal reasons. Presenting early experience in transitioning is important for clinicians.
METHODS: A retrospective case series of 11 patients who were exposed to brodalumab from clinical trials that ended abruptly and transitioned to secukinumab is presented.
RESULTS: This is an early descriptive experience of transitioning between two IL-17 antagonists.
LIMITATIONS: A small number of patients were available and a short follow up limited the data presented.
CONCLUSION: Transitioning between two IL-17 antagonists is an option for those patients requiring such a change. J Drugs Dermatol
Unfortunately, clinical trials all must end and in doing so, any benefits that may have been achieved by the study subject volunteering for the clinical trial may be lost, especially in clinical trials for psoriasis where chronic disease has a higher recurrence rate when removing effective therapy. Occasionally, long remission rates are seen in some patients, but this is unpredictable and variable. Some patients, whether in a clinical trial or not, experience primary failure (lack of initial efficacy). These patients usually drop out of clinical trials or are withdrawn as per protocol. Some patients experience secondary failure (loss of efficacy with time) that may require dose optimization, adjunctive therapy, or transition to or sequencing to another biologic in the same or different class of the original biologic.
Rarely, however, does transitioning or sequencing to another biologic occur when there is no failure of the original biologic the patient is taking and a change in biologic is “forced” upon the patient for other reasons. One of these reasons may be lack of availability of the biologic that the patient is taking. This lack could be due to manufacturing difficulties, safety reasons, affordability, insurance issues, or personal choice. This change in biologic from the original (old) biologic to the new biologic, whether in the same class or not, may not achieve the same result or provide similar satisfaction to the patient. However, choosing another safe and effective biologic for the transition is key to patient satisfaction, continued clinical improvement and quality of life.
It is well documented that there is considerable variation in responses between patients. There is also variation between treatments when using biologics in patients with moderate to severe psoriasis. This variation reflects the clinical and genetic heterogeneity of psoriasis and genetic polymorphisms in drug metabolism and response.1 Although IL-17 blockers act upon the IL-17 pathway, these biologics have distinguished characteristics with respect to structure, mechanism of action, pharmacokinetics, and pharmacodynamics. This may give a variable response rate. However, the factors of above can’t explain why one IL-17 blocker that fails may not preclude the effectiveness of another IL-17 blocker. This case series does not concern itself with the failure of one and transition to another but the exact opposite. These are successful cases of response to one biologic (brodalumab) transitioning to another biologic in the same class with continued improvement (secukinumab).
A retrospective chart review of 11 patients with moderate to severe plaque psoriasis who were previously enrolled in a clinical trial with brodalumab was carried out. No data from the clinical trial were obtained nor will be presented in order to maintain confidentiality. All patients were seen in regular follow-up shortly after the trial was discontinued when the sponsor decided not to continue product development for psoriasis in Canada and United States. Discussion with the