Background Currently, the available evidence about tocilizumab (TCZ) use for the treatment of rheumatoid arthritis (RA) in daily clinical practice is scarce.
Objectives To describe usage patterns of TCZ and reasons for dosage modification (reduction/interruption/discontinuation) in the routine clinical practice.
Methods This is a 12-month prospective observational study in 40 Spanish centers. Patients with moderate or severe RA of ≥6 months duration initiated on treatment with TCZ after failure of at least one previous DMARD or TNF inhibitor were included.
Results A total of 369 patients were evaluated with a median age of 57 years (47-66) and 83% female. At baseline, patients had median disease duration of 9 years (5-16), 70% and 69% were rheumatoid factor and anti-CCP positive, respectively. Mean DAS28, SDAI, HAQ scores and CRP levels were 5.5±1.2, 22.8±15, 1.6±0.7 and 6.4±13.7 mg/dL, respectively. Comorbidities commonly reported were hypertension (29.5%), osteoporosis (28.7%) and hypercholesterolemia (28.2%). From RA diagnosis to starting TCZ therapy, 99.5% of patients were given DMARDs (mean of 3±1.5), 94% steroids and 84.6% biological therapy, of whom 71% had received ≥2 biologic agents. Treatments immediately before TCZ were DMARDs (82.9%), biologics (74.8%) and steroids (78.9%). Table reports reasons for starting TCZ treatment.
Of all patients, 15.4% received TCZ as a first-line biological agent, 24.7% as second-line and 59.9% at least as third-line. Most patients (78%) initiated TCZ in combination (60% with MTX), and at doses of 8 mg/kg (97.3%). No differences in patients and disease characteristics were found with regard to TCZ use as monotherapy or in combination, and to line-biological option.
Patients showed intolerance to biologic agents or DMARDs were more frequently initiated on TCZ as monotherapy, with 39.5% of them given TCZ alone vs 20.5% in combination (p<0.001, Fisher’s test). Of those failing previous biologics because of inadequate response and/or intolerance, 93.8% receiving TCZ alone vs 80.6% combined (p<0.01).
Conclusions These results indicate that in clinical practice, TCZ is mainly used in combination with MTX in patients who have not responded to DMARDs or biologic agents. The use of TCZ as monotherapy is associated with intolerance to DMARDs or biologic agents. No significant differences were found among groups analyzed by patterns of TCZ use.
Disclosure of Interest J. Tovar Beltrán: None Declared, M. Guzmán Úbeda: None Declared, I. Mateo Bernardo: None Declared, R. García-Vicuña Grant/Research support from: MSD, UCB, Roche and Pfizer, M. Rodríguez-Gόmez: None Declared, M. Belmonte-Serrano: None Declared, C. Marras: None Declared, E. Loza Cortina: None Declared, J. Gόmez-Reino Consultant for: Roche, V. Vila: None Declared, A. Romero Silva Employee of: Roche Farma Spain, A. Balsa Speakers Bureau: Roche and other companies