Button, Peter

Caporali, Roberto

Casado, Gustavo

Czirják, Laszlo

Haraoui, Boulos

Hinsch Gylvin, Lykke

Taylor, Andrew

Theander, Elke

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E42. PATTERNS OF TOCILIZUMAB USE AND SAFETY INPATIENTS WITH RHEUMATOID ARTHRITIS: INTERIMRESULTS FROM ACT-UP: A MULTINATIONALOBSERVATIONAL STUDYBoulos Haraoui1, Gustavo Casado2, Elke Theander3, Laszlo Czirja´k4,Andrew Taylor5, Peter Button6, Lykke Hinsch Gylvin7 andRoberto Caporali81Rheumatology Department, Institut de Rhumatologie, Montreal, QC,Canada, 2Me´dico Reumato´logo, Hospital Militar Central, BuenosAires, Argentina, 3Department of Rheumatology, Ska˚ne UniversityHospital Malmo¨, Lund University, Sweden, 4University of Pe´cs,Medical Centre, Pe´cs, Hungary, 5Rheumatology Department, RoyalPerth Hospital, Perth, 6Medical Department, Roche Products PtyLimited, Dee Why, Australia, 7Medical Department, F Hoffmann-LaRoche, Basel, Switzerland and 8University of Pavia, IRCCS S. MatteoFoundation, Pavia, ItalyBackground: Tocilizumab (TCZ) is indicated for RA patients withinadequate responses to DMARDs, either as monotherapy (Mono) or incombination with DMARDs (Combo). ACT-UP pools data from severalinternational, observational, post-marketing studies of i.v. TCZ. Interimobservations of patterns of TCZ-use in RA patients, adherence to labelrecommendations and safety are reported.Methods: Adult patients with moderate-to-severe RA who started TCZin routine practice were observed in clinical practice for 6 months.There were no specified dosing regimens (concomitant RA treatmentspermitted) and no interventional procedures, clinic visits, or laboratoryanalyses outside routine practice.Results: Data are reported for 961 patients receiving TCZ [352 (37%)initiated as Mono and 609 (63%) as Combo]. 94% and 95% of Monoand Combo patients, respectively, started TCZ at 8 mg/kg, and 93%and 94% of patients, respectively, taking TCZ at 6 months received8 mg/kg. TCZ dose changes occurred in 34 (10%) Mono patients(7 increased, 11 decreased, 16 increased and decreased) and 68(11%) Combo patients (13 increased, 20 decreased, 35 increased anddecreased). Reasons for dose changes were: adverse events (AEs; 4%Mono; 5% Combo) and lack of efficacy (2% Mono; 1% Combo).Median MTX dose for Combo patients was 15.0 mg/week. 63 patientschanged MTX dose (median dose change 5.0 mg/week). 28 (8%) ofTCZ mono patients added a DMARD during the study. Corticosteroidswere used by 57% of Mono and 70% of Combo patients (medianprednisone-equivalent dose (at baseline) 7.5 and 5.0 mg/day, respec-tively). At 6 months, 72% of Mono and 84% of Combo patients werestill receiving TCZ. 100 (10%) patients discontinued TCZ in the first3 months; 94 (10%) in the next 3 months (reasons: lack of efficacy(11% Mono; 27% Combo), AEs (27% Mono; 29% Combo), otherreasons (62% Mono; 44% Combo). AEs occurred in 53% of patients(Table 1). Infections were less common in Mono patients. Nogastrointestinal perforations were reported.Conclusion: In clinical practice, 37% of patients started TCZ asmonotherapy and most patients continued with TCZ treatment (Monoand Combo) 6 months after initiation. TCZ was well tolerated in bothgroups.Disclosure statement: B.H. has acted as a consultant for AbbVie,Amgen, BMS, Janssen, Pfizer, Roche and UCB; and has receivedresearch grants from AbbVie, Amgen, BMS, Janssen, Roche, UCB. G.C.has acted as a consultant for Abbott, Pfizer, Janssen, Roche and GSK.E.T. has acted as a consultant for Roche. L.C. has acted as a consultantfor AbbVie, Pfizer, Roche, UCB and MSD. A.T. has acted as a consultantfor AbbVie, Roche, Celgene, Janssen, BMS and UCB; and has servedon speakers’ bureaus on behalf of AbbVie, Roche, Janssen, BMS andUCB. P.B. is an employee of Roche. L.H.G. is an employee of Roche.R.C. has acted as a consultant for AbbVie, BMS, Roche, UCB and MSD.E42 TABLE 1. Safety data from ACT-UP (6 months)TCZ Mono(n¼ 352)TCZ Combo(n¼609)All patients(n¼ 961)AEs, n (%) 185 (52.6) 324 (53.2) 509 (53.0)Rate per 100 py 193 205 201AEs by SOCaInfections and infestations 56 (15.9) 132 (21.7) 188 (19.6)Investigations 38 (10.8) 71 (11.7) 109 (11.3)Musculoskeletal and connectivetissue disorders33 (9.4) 52 (8.5) 85 (8.8)Gastrointestinal disorders 29 (8.2) 49 (8.0) 78 (8.1)Skin and s.c. tissue disorders 28 (8.0) 44 (7.2) 72 (7.5)General disorders and administrationsite conditions22 (6.3) 34 (5.6) 56 (5.8)Blood and lymphatic system disorders 20 (5.7) 44 (7.2) 64 (6.7)Nervous system disorders 18 (5.1) 32 (5.3) 50 (5.2)Metabolism and nutrition disorders 18 (5.1) 23 (3.8) 41 (4.3)SAEs, n (%) 34 (9.7) 49 (8.0) 83 (8.6)Rate per 100 py 23 19 21Infection SAEs, n (%) 6 (1.7) 15 (2.5) 21 (2.2)Total AEs leading to withdrawal, n (%) 32 (9.1) 42 (6.9) 74 (7.7)Rate per 100 py) 21 14 16AEs leading to withdrawal by SOCbSkin and s.c. tissue disorders, n (%) 6 (1.7) 5 (0.8) 11 (1.1)Infections and infestations, n (%) 5 (1.4) 6 (1.0) 11 (1.1)Gastrointestinal disorders, n (%) 4 (1.1) 1 (0.2) 5 (0.5)Cardiac disorders, n (%) 4 (1.1) — 4 (0.4)Blood and lymphatic systemdisorders, n (%)3 (0.9) 7 (1.1) 10 (1.0)Rate per 100 py is based on total number of events during TCZ exposure,determined for each patient as date of last TCZ dosedate of first TCZ doseþ 28days. aReported in 5% of patients in a treatment group. bReported in 1% ofpatients in a treatment group. Combo: in combination with DMARDs; Mono:monotherapy; py: patient-years; SAEs: serious AEs; SOC: system organ class;TCZ: tocilizumab.i188 E-POSTER ABSTRACTS

E42. Patterns of Tocilizumab Use and Safety in Patients with Rheumatoid Arthritis: Interim Results from Act-Up: A Multinational Observational Study

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E42. Patterns of Tocilizumab Use and Safety in Patients with Rheumatoid Arthritis: Interim Results from Act-Up: A Multinational Observational Study

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