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Safety of Satralizumab Based on Pooled Data from Phase 3 Studies in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) Scan here to access the full presentation PDF or visit: https://bit.ly/2V7rvuc

Disclosures B. Greenberg has received grants from Chugai, MedImmune, Genentech, B. G. Weinshenker reports consulting fees from Mitsubishi Tanabe, Caladrius MedDay, PCORI, NIH, NMSS, and Guthy Jackson Charitable Foundation Biosciences, Roivant, and Brainstorm Therapeutics; he was a member of for NMO; and received consulting fees from Novartis, Alexion, and EMD the Data Safety Monitoring Committee for Novartis and participated on Serono. He is a board member of the Transverse Myelitis Association. the Attack Adjudication Committee for Alexion and MedImmune/Viela Bio. He reports personal fees from Chugai for the submitted work. He has a J. de Seze has received grants and personal fees from Roche; personal patent NMO-IgG for diagnosis of neuromyelitis optica with royalties paid to fees from Chugai; and has served advisory boards in Expert committee for RSR Ltd.; Oxford University; Hospices Civil de Lyon, MVZ Labor PD Dr. the clinical trial conducted by Chugai Volkmann und Kollegen GbR. E. Fox has received honoraria for advisory, consulting, speakers’ bureau, C. Marcillat, X. Kou and K. Weber are employees of F. Hoffmann-La Roche and/or research support from AbbVie, Biogen, Celgene, Chugai, EMD Ltd Serono, Genentech/Roche, MedDay, Novartis, Sanofi Genzyme, and TG Therapeutics. This study was funded by Chugai Pharmaceutical Co. Ltd, Tokyo, Japan. Editorial assistance was provided by ApotheCom, UK. A. Saiz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck-Serono, Sanofi, Biogen, Roche, TEVA, Novartis, and Bayer-Schering. T. Yamamura has served on scientific advisory boards for Biogen, Takeda, Sumitomo, Novartis, and Chugai; received research grants from Chugai, Biogen, Novartis, Teva, Chiome Bioscience, and Miraca Holdings; he received speaker honoraria from Chugai, Takeda, Biogen, Sumitomo

Satralizumab has been evaluated in two phase 3 studies: SAkuraSky (in combination with baseline IST) and SAkuraStar (monotherapy) Double-blind period OLE period Baseline 0 2 4 8 12 16 20 LA* 0 2 4 8 12 LA* LO † Administration of Week satralizumab or placebo Satralizumab 120 mg q4w sc Randomization Relapse ‡ Satralizumab 120 mg q4w sc Overall satralizumab period Placebo (+ IST in SAkuraSky) SAkuraSky (Satralizumab + baseline IST) SAkuraStar (Satralizumab monotherapy) (N=83; 1:1 randomization) (N=95; 2:1 randomization) • Aged from 12 – 74 • Aged from 18 – 74 • NMO ‖ (AQP4-IgG+/-) or NMOSD ¶ (AQP4-IgG+) patients • NMO ‖ (AQP4-IgG+/-) or NMOSD ¶ (AQP4-IgG+) patients Main inclusion criteria • ≥2 relapses in last 2 years (≥1 relapse in last year) • ≥1 attack in last year • Stable treatment with AZA, MMF, and/or OCs Total number of PDR reaches 44, or 1.5 years after the date of Total number of PDR reaches 26 (CCOD 6 th Jun 2018) End of double-blind period randomization of the last patient enrolled (CCOD 12 th Oct 2018) CEC-confirmed PDR or clinical relapse requiring rescue therapy Criteria for entry into OLE CEC-confirmed PDR Primary endpoint met for Time to first PDR: 62% reduced risk (HR 0.38 [95% CI, 0.16, 0.88]) Time to first PDR: 55% reduced risk (HR 0.45 [95% CI, 0.23, 0.89]) both trials *Last administration; †Last observation; ‡Relapse adjudicated by CEC; ‖ Defined by Wingerchuk et al 2006 criteria; ¶Defined by Wingerchuk et al 2007 criteria with either LETM or ON. OLE median treatment exposure: 48.7 weeks (range 10 – 98). AQP4-IgG, aquaporin 4 immunoglobulin G; AZA, azathioprine; CCOD, clinical cut-off date; CEC, clinical endpoint committee; CI, confidence interval; IST, immunosuppressants; HR, hazard ratio; LETM, longitudinally extensive transverse myelitis; MMF: mycophenolate mofetil; OCs, oral corticosteroids; OLE, open-label extension; ON, optic neuritis; PDR, protocol-defined relapses; sc, subcutaneous. 1. Yamamura T, et al. N Engl J Med 2019;381(22):2114 – 2124. 2. Traboulsee A, et al. Lancet Neurol 2020;19:402 – 412.

In the overall satralizumab treatment period for the two studies, 166 patients were exposed to at least one dose of satralizumab Double-blind period Overall satralizumab treatment period (up to SAkuraSky SAkuraStar Pooled a CCOD of 7 Jun 19)* (N=83) (N=95) (N=178) Satralizumab + BL Placebo + BL Satralizumab Placebo Satralizumab Placebo Satralizumab (N=166) (n=41) (n=42) (n=63) (n=32) (n=104) (n=74) Mean exposure (SD), 94.1 (72.6) 66.0 (61.4) 91.1 (56.4) 61.4 (51.4) 92.3 (63.0) 64.0 (57.0) 133.3 (74.5) weeks Median exposure 107.4 (2 – 224) 32.5 (0 – 180) 92.3 (0 – 202) 54.6 (2 – 216) 93.7 (0 – 224) 42.6 (0 – 216) 128.6 (4 – 276) (range), weeks Fewer patients experienced relapses in the satralizumab arms, so the average double-blind exposure was ▪ higher with satralizumab than with placebo Satralizumab exposure was further increased when including data from the OLE, as all patients received ▪ satralizumab in the OLE The first patients are now reaching 5.5 years of satralizumab treatment exposure ▪ Duration of exposure to study drug (weeks) is defined as (date of last dose - date of first dose + 1)/7. *The overall satralizumab treatment period includes cumulative data from the DB and the OLE. BL, baseline immunosuppressants; CCOD, clinical cut-off date; OLE, open-label extension; SD, standard deviation. Data on file.

In the two studies, the overall rate of AEs and serious AEs was comparable between the placebo and satralizumab groups in the double-blind period There were no deaths or anaphylactic reactions 1 ▪ The most commonly reported AEs were upper respiratory tract infection and urinary tract infection and were ▪ mild or moderate in severity, with similar frequencies in both treatment groups 1 The number of withdrawals due to AEs was low in both studies 2,3 ▪ Satralizumab ± IST (n=104) 1 Placebo ± IST (n=74) 1 (pooled data) Patients Events per 100 PY Patients Events per 100 PY n (%) (95% CI) n (%) (95% CI) Adverse events 95 (91.3) 478.5 (448.2, 510.3) 64 (86.5) 506.5 (463.4, 552.6) URTI 20 (19.2) 23.7 (17.4, 31.7) 12 (16.2) 26.0 (17.0, 38.1) UTI 18 (17.3) 22.7 (16.5, 30.5) 15 (20.3) 32.0 (21.9, 45.1) Headache 20 (19.2) 18.1 (12.6, 25.1) 8 (10.8) 11.0 (5.5, 19.7) Serious AEs 19 (18.3) 15.0 (10.0, 21.5) 14 (18.9) 18.0 (10.7, 28.4) Severe AEs* 22 (21.2) 7 (9.5) 21.7 (15.6, 29.3) 11.0 (5.5, 19.7) Withdrawals due to AEs 2,3 4 (3.8) 6 (8.1) - - Infections † 62 (59.6) 40 (54.1) 113.0 (98.6, 129.0) 154.9 (131.4, 181.2) Serious infections † 8 (7.7) 4.1 (1.8, 8.1) 6 (8.1) 7.0 (2.8, 14.4) Injection-related reactions 13 (12.5) 7 (9.5) 17.0 (11.7, 23.9) 9.0 (4.1, 17.1) *Severe AEs were defined as incapacitating AEs affecting the patient’s ability to work or to perform normal daily activities. † MedDRA system organ class: infections and infestations. AE, adverse event; CI, confidence interval; IST, immunosuppressants; MedDRA, Medical Dictionary for Regulatory Activities; PY, patient-years; URTI, upper respiratory tract infection; UTI, urinary tract infection. 1. de Seze J, et al. Poster presented at ECTRIMS 2019, Stockholm, Sweden, 11 – 13 September 2019. Poster no. P1614. 2. Yamamura T, et al. N Engl J Med 2019;381(22):2114 – 2124. 3. Traboulsee A, et al. Lancet Neurol 2020;19:402 – 412.

The safety profile of satralizumab in the overall satralizumab treatment period was consistent with the double-blind period Rates of AEs and serious AEs did not increase with longer exposure to satralizumab ▪ Consistent with the double-blind period, the most frequently reported AEs in the overall satralizumab ▪ treatment period were those belonging to the SOC Infections and Infestations The rates of the most frequently reported AEs were comparable with the double-blind period – Overall satralizumab treatment period* Satralizumab, double-blind period (up to a CCOD of 7 Jun 19) N = 104; PY = 193.74 N = 166; PY = 437.69 Patients Events per 100 PY Patients Events per 100 PY n (%) (95% CI) n (%) (95% CI) 153 (92.2) 95 (91.3) 478.49 (448.18, 510.31) 418.79 (399.83, 438.41) Adverse events URTI 20 (19.2) 23.74 (17.38, 31.67) 38 (22.9) 25.13 (20.66, 30.29) Nasopharyngitis 19 (18.3) 17.03 (7.65, 23.47) 20.11 (16.13, 24.77) 37 (22.3) UTI 18 (17.3) 22.71 (16.50, 30.49) 18.51 (14.70, 23.00) 29 (17.5) Serious AEs 19 (18.3) 14.97 (10.02, 21.50) 35 (21.1) 12.57 (9.47, 16.36) Severe AEs † 22 (21.2) 21.68 (15.62, 29.30) 34 (20.5) 15.08 (11.66, 19.18) Withdrawals due to AEs 4 (3.8) - 7 (4.2) - Infections ‡ 62 (59.6) 109 (65.7) 112.41 (102.69, 122.79) 113.04 (98.56, 129.04) Serious infections ‡ 8 (7.7) 4.13 (1.78, 8.14) 16 (9.6) 3.88 (2.26, 6.22) Injection-related reactions 13 (12.5) 17.03 (11.73, 23.92) 21 (12.7) 12.11 (9.07, 15.84) *The overall satralizumab treatment period includes cumulative data from the DB and the OLE. † Severe AEs were defined as incapacitating AEs affecting the patient’s ability to work or to perform normal daily activities. ‡ MedDRA SOC: infections and infestations. AE, adverse event; CCOD, clinical cut-off date; CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities; PY, patient-years; SOC, system organ class; URTI, upper respiratory tract infection; UTI, urinary tract infection. Data on file.