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Safety of Specifically Targeting Interleukin 13 with Tralokinumab In Safety of specifically targeting interleukin 13 with tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled Phase 3 and Phase 2 trials Eric Simpson,1 Joseph F Merola,2 Jonathan I Silverberg,3 Rebecca Zachariae,4 Christina Kurre Olsen,4 Andreas Wollenberg5 1Department of Dermatology, Oregon Health & Science University, Portland, OR, USA; 2Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA; 3Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA; 4LEO Pharma A/S, Ballerup, Denmark; 5Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, Munich, Germany ● AEs are summarised by the number and proportion of patients with AEs and the number and rate of Safety: monotherapy pool events by treatment group Table 3. Overall safety summary (safety analysis set, initial treatment period) ● Medical Dictionary for Regulatory Activities (MedDRA) version 2.0 was used (initial and maintenance treatment period) Introduction ● The overall frequency of AEs during the initial treatment period was similar for tralokinumab (69.0%) ● Event rates are presented as the number of events per 100 patient-years of exposure (PYE) AD pool Monotherapy pool and placebo (71.5%) and similar to the AD pool (Table 3) ● Atopic dermatitis (AD) is a chronic, debilitating, inflammatory skin disease1,2 characterised by Statistical analysis — The majority of AEs were mild or moderate in severity eczematous lesions and multiple symptoms, including pruritus, sleep disturbance and depression.3-5 ● Cochran-Mantel-Haenszel weights were applied to calculate adjusted AE incidences for the initial Tralokinumab Placebo Tralokinumab Placebo ● The safety profile during prolonged tralokinumab treatment from 16–52 weeks in the monotherapy The type 2 cytokine interleukin 13 (IL-13) is a key driver of the underlying inflammation of AD and is treatment period to account for varying randomisation rates between tralokinumab and placebo in (n=1605; PYE=473.19) (n=680; PYE=193.1) (n=1194; PYE=354.46) (n=396; PYE=114.47) pool was consistent with the initial 16-week treatment period, based on overall frequencies of AEs, overexpressed in lesional and non-lesional AD skin6,7 the trials SAEs, severe AEs and AEs leading to permanent discontinuation (Figure 2) n n n n ● Tralokinumab is a fully human immunoglobulin G4 monoclonal antibody that specifically binds to E adj. R E adj. R E adj. R E adj. R ● The overall rate of AEs for tralokinumab q2w during the maintenance treatment period was lower ● Risk ratios were estimated from a Poisson regression with treatment as fixed effect, and log values (adj. %) (adj. %) (%) (%) the IL-13 cytokine with high affinity, preventing interaction with the IL-13 receptor and subsequent than in the initial treatment period (499.3 vs 699.4 events per 100 PYE) and higher than patients 6-8 of PYE were used as offset variable downstream IL-13 signalling, thus preventing its pro-inflammatory activity Events 1080 (65.7) 3148 6 3 9. 5 449 (67.2) 1276 678.3 824 (69.0) 2479 699.4 283 (71.5) 899 785.3 re-randomized to tralokinumab every 4 weeks (q4w) or placebo (414.2 and 442.1 events per 100 PYE, ● Tralokinumab 300 mg every 2 weeks (q2w), as monotherapy and in combination with topical respectively) Serious 37 (2.1) 38 7. 4 18 (2.8) 22 11.9 33 (2.8) 34 9. 6 13 (3.3) 17 14.9 corticosteroids (TCS), was efficacious in the treatment of patients with moderate-to-severe AD in ● The most frequently occurring AEs (in 5% of patients [MedDRA PT]) for all treatment groups during three pivotal Phase 3 ECZTRA trials (ECZTRA 1 [NCT03131648], ECZTRA 2 [NCT03160885] and ECZTRA the maintenance period were generally in line with the most frequently occurring AEs during the 9 Severity 3 [NCT03363854]), a Phase 2 trial (ECZTRA 5 [NCT03562377]) and a Phase 2b trial (NCT02347176) Results initial treatment period in the AD pool and were atopic dermatitis, viral upper respiratory tract Mild 881 (53.2) 2127 429.8 326 (49.0) 738 391.0 673 (56.4) 1654 466.6 204 (51.5) 500 436.8 ● infection, upper respiratory tract infection and injection site reaction (Figure 2) It is important to understand the safety profile of therapeutics used for the long-term treatment of Moderate 518 (31.5) 917 189.5 258 (39.0) 478 254.3 409 (34.3) 733 206.8 182 (46.0) 350 305.7 patients with AD Patient demographics and clinical characteristics Severe 77 (4.6) 104 20.2 40 (6.3) 60 33.0 65 (5.4) 92 26.0 32 (8.1) 49 42.8 ● Lower rates of SAEs, severe AEs and AEs leading to permanent discontinuation were also seen for — A good safety profile is an important attribute for patients when selecting a treatment for AD10 tralokinumab in the maintenance versus initial treatment period ● For the initial treatment period, the AD pool included 2285 patients: Drug withdrawn (action taken) 38 (2.3) 47 9.9 20 (2.8) 25 13.3 29 (2.4) 34 9. 6 11 (2.8) 16 14.0 1605 treated with tralokinumab 300 mg q2w (exposure for the entire treatment period, 1403.9 PYE) and 680 with placebo q2w (exposure for the entire treatment period, 272.6 PYE) a Outcome Figure 2. The 15 most frequent AEs by preferred term (safety analysis set, monotherapy pool, — Patient demographics and clinical characteristics were similar across treatment arms (Table 2) Fatal 1 (0.1) 1 0.4 0 0 0 0 0 0 0 0 0 maintenance treatment period) Objective Not recovered/not resolved 232 (14.3) 312 65.4 90 (13.5) 126 65.2 167 (14.0) 229 64.6 60 (15.2) 78 68.1 Recovering/resolving 79 (5.0) 87 18.9 36 (5.4) 45 22.7 56 (4.7) 60 16.9 22 (5.6) 25 21.8 Table 2. Baseline patient demographics and clinical characteristics (safety analysis set, AD pool) Recovered/resolved 997 (60.2) 2699 544.5 416 (62.4) 1096 585.4 769 (64.4) 2152 607.1 264 (66.7) 789 689.2 Tq2w/Tq2w Tq2w/Tq4w Tq2w/placebo Placebo/placebo Patients, % ● 0 5 10 15 20 25 30 35 To provide an overview of the pooled safety data from three Phase 3 ECZTRA trials and two Recovered/resolved with sequelae 18 (1.0) 18 3.5 2 (0.3) 3 1.7 15 (1.3) 15 4.2 2 (0.5) 3 2.6 % R % R % R % R Phase 2 trials to evaluate the safety of tralokinumab 300 mg q2w in adult patients with Tralokinumab (n=1605) Placebo (n=680) Unknown 27 (1.7) 31 7.0 6 (0.9) 6 3.3 21 (1.8) 23 6.5 4 (1.0) 4 3.5 Dermatitis atopic 15.1 46.0 1 7.0 46.8 2 7. 2 88.9 13.3 41.1 moderate-to-severe AD Viral upper respiratory tract infection 14.5 31.9 14.5 36.5 13.6 31.4 10.0 37.7 Sex, n (%) Upper respiratory tract infection 9. 4 22.4 6.7 17.1 4.9 10.5 5.0 10.3 adj., adjusted; E, event; R, rate, PYE, patient-years of exposure Injection site reaction 5.7 29.5 6.7 28.5 1.2 2.6 0.0 0.0 Male 921 (57.4) 375 (55.1) Bronchitis 2.5 4.7 6.1 12.6 2.5 5.2 3.3 6.9 Conjunctivitis 5.0 13.0 3.0 8.0 2.5 5.2 1.7 3.4 Female 684 (42.6) 305 (44.9) a ● The monotherapy pool included 1590 patients: 1194 treated with tralokinumab 300 mg and 396 Table 4. Most frequent AEs leading to permanent discontinuation of study drug by preferred term Headache 5.0 16.5 2.4 4.6 3.7 15.7 0.0 0.0 (safety analysis set, AD pool, initial treatment period) Oral herpes 1.3 4.7 1.8 3.4 1.2 2.6 5.0 13.7 Methods Mean age, years (SD) 37.9 (14.3) 37.0 (14.3) treated with placebo q2w Asthma 3.8 7. 1 2.4 6.8 3.7 10.5 1.7 3.4 ● As the monotherapy pool constituted the majority of the AD pool, the monotherapy pool resembled Back pain Age group, n (%) Tralokinumab Placebo 3.8 9. 4 3.6 6.8 0.0 0.0 1.7 3.4 the AD pool in baseline demographics and clinical characteristics, with no major differences Influenza 3.8 8.3 2.4 4.6 2.5 5.2 0.0 0.0 Study designs (n=1605; PYE=473.19) (n=680; PYE=193.1) 18–64 years 1528 (95.2) 648 (95.3) between patients in the tralokinumab q2w and placebo treatment groups Injection site pain 3.8 16.5 3.0 5.7 0.0 0.0 0.0 0.0 ● Five placebo-controlled trials formed the AD pool: Phase 3 (ECZTRA 1, ECZTRA 2 and ECZTRA 3), Conjunctivitis allergic 3.1 5.9 2.4 4.6 3.7 7. 8 0.0 0.0 Phase 2 (ECZTRA 5) and Phase 2b 65 years 77 (4.8) 32 (4.7) Preferred term n (adj. %) E adj. R n (adj. %) E adj. R Dry eye 0.6 1.2 0.0 0.0 3.7 10.5 0.0 0.0 Safety: AD pool (initial treatment period) Hypertension 1.3 2.4 1.8 3.4 3.7 7.
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