The device, which was recently approved by Swissmedic, enables psoriasis sufferers to self-administer the biologic in single doses. It is currently the only IL23 inhibitor available in Switzerland in the form of a patient-controlled injector.
The new TREMFYA® prefabricated pen [1] is not an autoinjector as with other biologics in the therapy of moderate to severe plaque psoriasis. The innovative design of the TREMFYA® prefabricated pen allows patients to control the intensity and pressure of their injection themselves. In the ORION study, nearly 99% of patients reported a successful first injection [2]. In addition, the pre-filled pen includes a safety system to protect the needle after use. Even after three injections, patients in the study continued to rate the use of the TREMFYA® pen as positive [2].
Convincingly simple handling
Psoriasis patients sometimes have difficulty with self-administered forms of treatment due to a number of factors. In the randomized phase III ORION trial [2] conducted at multiple study sites, patients’ subjective assessment in this regard was evaluated using a validated questionnaire (Self-Injection Assessment Questionnaire, SIAQ) [3]. This involved assessing patients’ experiences with the TREMFYA® prefabricated pen at weeks 0, 4, and 12 on a scale of 0 (“worst”) to 10 (“best”) using the following six criteria:
- Sensations regarding injections
- Self-image, self-confidence
- Pain and skin reactions during or after injection
- Ease of use of the device
- Satisfaction with self-injection
The mean score for the criterion “satisfaction with self-injection” in the study was 9.18 points (10=”very satisfied”) and the mean score for “ease of use” was 9.24 points (10=”very easy”) [2].
Good efficacy and safety
In the ORION study efficacy and safety review, a significantly greater proportion of study participants achieved clearance of IGA0 or IGA1 (81% vs. 0%) and a PASI 90 response rate (76% vs. 0%), respectively, at week 16 in the TREMFYA® pre-cast group compared to placebo. The proportion of participants achieving a PASI100 response at week 16 was also significantly higher in the TREMFYA® pre-cast group than in the placebo group (50% vs. 0%). The majority of injection site reactions with the TREMFYA® prefabricated pen were mild and transient in nature [2].
Already in summer 2018, TREMFYA® (guselkumab) in conventional administration form had received marketing authorization in Switzerland for the treatment of adult patients with moderate to severe plaque psoriasis and inadequate response to other systemic therapies or PUVA [1]. Guselkumab was generally well tolerated by patients with psoriasis during clinical development [4–6]. Also, over the open-label period of 4 years, no new safety signals were identified with the use of this fully human monoclonal antibody [7].
The most important in a nutshell
- The TREMFA® prefabricated pen is a patient-controlled injector. It is currently the only IL23 inhibitor in Switzerland in this administration form.
- In the Self-Injection Assessment Questionnaire (SIAQ), the criterion “ease of use” was assessed with an average of 9.24 points (maximum: 10 points) [2].
- In the ORION trial, a significantly higher proportion of patients in the TREMFYA® pre-cast group achieved IGA1 or IGA0 (81% vs. 0%) and PASI90 or PASI100 (76% vs. 0%), respectively, at week 16 after baseline compared to placebo [2].
Literature:
- Tremfya® Technical Information, as of 09/2019 available at www.swissmedicinfo.ch.
- Ferris LK, et al: Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study. J Dermatol Treat 2019: 1-8. doi:10.1080/09546634.2019.1587145
- Keininger D, Coteur G: Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ) Health and Quality of Life Outcomes 2011; 9, Article number 2.
- Blauvelt A, et al: Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017; 76(3): 405-417.
- Reich K, et al: Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017; 76(3): 418-431.
- Langley RG, et al: Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol 2018; 178(1): 114-123.
- Griffiths CE, et al: Fall Clinical Dermatology Conference. Oct, 2019; Las Vegas, USA
DERMATOLOGIE PRAXIS 2020; 30(1): 37 (published 2/24/20, ahead of print).
