The EMA-approved new route of administration for the IL-17A inhibitor allows the recommended dosage to be administered in a single injection. Data analyses of the pivotal phase IIIb MATURE study were presented at the World Psoriasis & Psoriatic Arthritis Conference 2021. Among other things, these demonstrate a high level of patient satisfaction.
Secukinumab is a monoclonal antibody that targets interleukin (IL)-17A. The clinical evidence of this biologic in the treatment of patients with plaque psoriasis and psoriatic arthritis is extensively documented [1,2]. The recommended dose of secukinumab (Cosentyx®) is 300 mg as a subcutaneous injection [3]. In addition to the 150 mg application form, Cosentyx® has been available in the EU as a 300 mg ready-to-use pen since mid-February 2021 [4].
MATURE study: improvements in various outcome parameters.
122 psoriasis patients were randomized to three study arms [5]: Secukinumab 300 mg 2 mL autoinjector (n=41), Secukinumab 300 mg 2× 1 mL pre-filled syringe/PFS* (n=41), or placebo (n=40). At week 12, both co-primary endpoints of the study were met, demonstrating that treatment with secukinumab 300 mg 2 mL AI and 2× 1 mL PFS resulted in superior PASI75 response rates (95.1% and 83.2%, respectively), as well as lesion-free or nearly lesion-free skin according to IGA (75.6% and 68.1%, respectively) vs. placebo (PASI75, 10.0%; IGA, 7.6%; p<0,0001). The proportion of patients achieving DLQI 0/1 at week 12 was similar in the secukinumab 300 mg groups (2 mL AI [71,1%] and 2× 1 mL PFS [72,5%]); on placebo, this proportion was 8.1%.
* PFS=pre-filled syringes
Neither needlestick injuries in critical localizations nor immediate-type allergies were observed. Patient satisfaction was assessed using the Self-Injection Assessment Questionnaire (SIAQ) and other instruments. In the secukinumab 300 mg 2 mL autoinjector group, the proportion of patients who reported being “very satisfied” or “satisfied” increased from 31.6% (pre-SIAQ) to 78.3% (post-SIAQ) after the first injection and continued to increase to 92.1% at week 12.
Conclusion
In summary, the secukinumab 300 mg 2 mL autoinjector route of administration was convincing in terms of both rapid response, high efficacy, and quality of life, as well as high patient satisfaction scores and a favorable safety profile. No new or unexpected safety signals appeared in the present study.
Source: Novartis
Literature:
- Blauvelt A, et al: Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: results from the CLEAR study. J Am Acad Dermatol. 2017;76(1): 60-9 e9.
- Strober BE, et al: No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2): e105-e7.
- Drug Information, www.swissmedicinfo.ch (last accessed Aug. 12, 2021).
- “Perspectives on Dermatology. Secukinumab: 300 mg Prefilled Pen – High Patient Satisfaction,” Supplement, Dtsch Arztebl 2021; 118(24).
- Browning J, et al: Secukinumab 300 mg in 2 mL autoinjector for treatment of plaque psoriasis: quality of life, usability, satisfaction, safety and tolerability results from the randomised, double-blind MATURE study, Poster abstracts, P77, World Psoriasis & Psoriatic Arthritis Conference, Stockholm, 30 Jun-03 Jul 2021.
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