Tolerability

SOTYKTU was generally well tolerated, with <3% of patients discontinuing treatment due to AEs between Weeks 0–16^1–4

SmPC list of AEs¹

A table showing the tolerability of Sotyktu - system organ class, frequency, and adverse reaction

Adapted from SOTYKTU SmPC.
Frequencies are defined as: very common ( 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare
(≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).¹

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The most commonly reported AE with SOTYKTU was upper respiratory infections (18.9%)¹
Between 0 and 52 Weeks, 4.6% of patients discontinued SOTYKTU (32/692) due to an AE, vs. 16.3% with apremilast (26/160)⁴

*Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, and rhinotrachetitis.
^†Herpes simplex infections include oral herpes, herpes simplex, genital herpes, and herpes viral infection.
^‡Oral ulcers include aphthous ulcer, mouth ulceration, tongue ulceration, and stomatitis.
**Acneiform rash includes acne, dermatitis acneiform, rash, rosacea, pustule, rash pustular, and papule.
AE, adverse event; SmPC, Summary of Product Characteristics.

In the PSO-1 and PSO-2 studies, SOTYKTU was generally well tolerated^1–3

AEs from PSO-1, Weeks 0–16 and PSO-2, Weeks 0–16^2,3

A graph showing the tolerability data taken from pooled PSO-1/PSO-2 studies

Adapted from Armstrong 2023 & Strober 2023.

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*A 57-year-old White female patient in the placebo group died on Day 23 due to sudden cardiac death. This patient had a history of obesity, obstructive sleep apnoea, and hypertensive cardiovascular disease.
^†A 75-year-old female patient in the SOTYKTU group died on Day 13 due to heart failure and sepsis, as reported by a family member, 9 days after discontinuing deucravacitinib treatment, which has been administered for 4 days and was discontinued due to use of a prohibited concomitant medication. This patient has a history of obesity, rheumatoid arthritis, hypertension, stroke, cardiac pacemaker implantation, and had multiple episodes of cardiac arrest resulting in hospitalisation, 1 day prior to death. This death was considered not related to deucravacitinib.
^‡A 76-year-old White male patient in the apremilast group died on Day 138 due to metastatic lung cancer and a gastrointestinal bleed. This patient had a history of hypertension, type 2 diabetes mellitus, and smoking. This death was considered not related to apremilast.
**≥5% in any treatment group.
AE, adverse event.

Rates of serious infections with SOTKTU⁴

Serious infection AEs with SOTYKTU

A table containing the rates of serious infection with Sotyktu, and where it occurred

Adapted from the SOTYKTU EPAR.

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Controlled safety pool:

Includes events with a start date between the first dose and +30 days post last dose or upon rollover into the PSO-LTE (IM011075):

Includes data from PSO-1 (IM011046) and PSO-2 (IM011047)
SOTYKTU exposure period (treatment duration Week 0-52): includes subjects treated with SOTYKTU at any time. This includes subjects randomised to SOTYKTU at Week 0, or switched from placebo to SOTYKTU at Week 16, or switched from apremilast to SOTYKTU at Week 24

Phase 3 safety pool:

Includes events with a start date between the first dose and +30 days post last dose date (discontinued subjects) or through safety cut-off date:

Includes subjects who were assigned to SOTYKTU in PSO-1 (IM011046), PSO-2 (IM011047, and the PSO-LTE (IM011075) (safety cut-off date = 15 July 2021)

AE, adverse event; LTE, long-term extension.

SOTYKTU drug-drug interactions¹

This information is based on in vitro and in vivo studies

Effect of other medicinal products on SOTYKTU

Medicinal products that are inhibitors or inducers of CYP enzymes or transporters such as cyclosporine (dual P-gp/BCRP inhibitor), fluvoxamine (strong CYP 1A2 inhibitor), ritonavir (moderate CYP 1A2 inducer), diflunisal (UGT 1A9 inhibitor), pyrimethamine (OCT1 inhibitor), famotidine (H2 recdeptor antagonist) or rabeprazole (proton pump inhibitor) do not meaningfully affect plasma SOTYKTU exposures (see section 5.2 of the SmPC)

Effect of SOTYKTU on other medicinal products

SOTYKTU does not meaningfully impact plasma exposures of rosuvastitin (BCRP and OATP substrate), methotrexate (substrate of BCRP and renal transporters), mycphenolate mofetil (CES1 and CES2 substrate), or oral contraceptives (norethindrone acetate and ethinyl estradiol)

BCRP, breast cancer resistance protein; CES, carboxylesterase; CYP cytochrome P; OATP, organic anion transporting polypeptides; OCT, organic cation transporter; P-gp, P-glycoprotein; SmPC, Summary of Product Characteristics; UGT, uridine diphosphate glucuronsyltranferase.

References

SOTYKTU. Summary of Product Characteristics.
Armstrong A et al. J Am Acad Dermatol. 2023;88(1):29–39. Plus supplementary material.
Strober B et al. J Am Acad Dermatol. 2023;88(1):40–51. Plus supplementary material.
SOTYKTU. European Product Assessment Report (EPAR). 26 January 2023. Available at https://www.ema.europa.eu/en/documents/assessment-report/sotyktu-epar-public-assessment-report_en.pdf (Accessed August 2023).