SAT0214 An analysis of increasing spacing time for the intravenous administration of tocilizumab in patients with rheumatoid arthritis
with methotrexate (MTX) was observed in 48% and with others classic DMARDs in 30%, while 22,3% received rituximab monotherapy. First-line rituximab option was justified by lung involvement in 21%, past malignancy in 13%, recurrent infections in 5%, congestive cardiac failure in 3%, vascular involvement in 3% and untreated latent tuberculosis in 3%. In the group previously exposed to biologics, 13% switched therapy due to ineffectiveness and 87% due to adverse events. No significant differences
... ere found between the 2 groups in terms of age, gender, concomitant use of MTX and baseline DAS28. The group previously exposed to biologics had a longer disease duration (mean 23 vs 15 years, p=0.001) and fewer patients with ACPA seropositivity (79% vs 97%, p=0.035). There was a significant reduction of DAS28 at 6, 12 and 18 months (p<0.001 for all). Fifty six percent of the patients achieved a EULAR response at 6 months, 46% at 12 months and 59% at 18 months. DAS28 variation at 6 months differed significantly between groups, with a better clinical response in naive biological patients comparing to those previously exposed to biologics (median 1.173 vs 0.477; p=0.038). There were no differences in terms of DAS28 variation at 12 and 18 months (p=0.642 and p=0.135, respectively) and in EULAR responses at 6, 12 and 18 months between the groups (p=0.289, p=0.523 and p=1.000, respectively). Conclusions: Our study confirms the effectiveness of rituximab in RA patients and suggests a higher magnitude of response in naive biological patients at 6 months of RTX therapy. These findings put in perspective an extension of rituximab as a first-line biologic for RA treatment. Background: Sarilumab is a human mAb blocking the IL-6Rα. In the phase 3 TARGET study (NCT01709578), sarilumab (150 or 200 mg SC q2w) + csDMARDs demonstrated efficacy in adults with active, moderate-to-severe RA and inadequate response or intolerance to ≥1 TNFi. Infections, neutropenia, injection site reactions, increased lipids, and increased transaminases were among the most common TEAEs. EXTEND (NCT01146652) is an open-label extension study evaluating long-term safety and efficacy of sarilumab in patients from the sarilumab clinical development program. Objectives: To examine the effects of dose reduction of sarilumab 200 mg q2w to 150 mg q2w in patients from TARGET that occurred in EXTEND primarily for protocol-specified laboratory abnormalities. Methods: Patients were switched to or initiated on sarilumab 200 mg q2w after enrolling in EXTEND. Per protocol, investigators could reduce the sarilumab dose from 200 mg q2w to 150 mg q2w for ANC ≥0.5 to 1.0 Giga/L, platelet count ≥50 to 100 Giga/L, or ALT ≥3 to 5×ULN. Dose reductions were also performed at the investigator's discretion. Efficacy data from EXTEND were analyzed before and 24 weeks after dose reduction. Results: As of the July 2016 interim analysis (N=452), dose reduction from sarilumab 200 mg q2w to 150 mg q2w had occurred in 14.6% of patients (n=66) from TARGET. The most common reasons for dose reduction were decreased ANC (8.8%; n=40) and increased ALT (3.3%; n=15). At the time of analysis, 80.3% of patients (n=53) whose dose was reduced were continuing treatment, with a median treatment duration of 1.6 years after dose reduction. Improvements in ANC and ALT were observed over the 6 months after dose reduction (Table 1) . Efficacy was maintained 24 weeks after dose reduction (Table 2) . Conclusions: In our database, 70% of RA patients received ABA were biologic naive. Remission or low-disease activity was achieved approximately 50% of patients in first follow-up visit with an average of 4.5 months after begining of the treatment. Functional improvement was observed in two thirds of patients.