Session Type: Poster Session (Tuesday)
Session Time: 9:00AM-11:00AM
Background/Purpose: The EXTEND open-label extension study (NCT01146652) is collecting data on long-term treatment of RA with sarilumab as monotherapy and in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), predominantly methotrexate. We conducted a post hoc analysis to compare outcomes between patients who received sarilumab monotherapy, sarilumab +csDMARDs, or discontinued csDMARDs during sarilumab treatment.
Methods: Patients enrolled in four trials of sarilumab SC 150 or 200 mg q2w +csDMARDs (MOBILITY, NCT01061736; TARGET, NCT01709578; ASCERTAIN, NCT01768572; and NCT01217814) and a sarilumab monotherapy study (ONE, NCT02121210) were eligible to receive open-label sarilumab SC 200 mg q2w in EXTEND, +csDMARDs if given in the parent trial. In EXTEND, csDMARDs could be stopped at the investigator’s discretion (reasons not recorded). Post hoc analyses were conducted on three groups: Group 1 permanently discontinued csDMARDs at any time during Weeks 0–96 of EXTEND and then received sarilumab monotherapy; Group 2 continued csDMARDs; and Group 3 enrolled from the monotherapy study and never received csDMARDs. A subgroup of Group 1, patients who received csDMARDs during Weeks 0–12 and discontinued csDMARDs during Weeks >12–96, was used for sensitivity analysis.
Results: There were 42 patients in Group 1, 1851 in Group 2, and 111 in Group 3, with minor differences between groups in demographics and disease characteristics at entry into EXTEND. At 96 weeks, 69%, 80%, and 83% of patients remained on study in Groups 1, 2, and 3, respectively. Similar substantial and durable response rates (Clinical Disease Activity Index [CDAI] ≤2.8 or ≤10, Disease Activity Score (28 joints)-C-reactive protein [DAS28-CRP] < 2.6 or < 3.2) were observed between patients who discontinued csDMARDs, patients who continued csDMARDs, and patients who never received csDMARDs (Figure). Results of the sensitivity analysis subgroup (n=27) were consistent with Group 1. The adverse event (AE) profile was as expected. AE incidence was greater in Group 1 than in Groups 2 and 3 (Table), including hepatic disorders (21, 7, 3 per 100 patient-years [PYs], respectively) and leukopenia (43, 13, 20 per 100 PYs, respectively). Rates of infection and serious infection were lowest in Group 3.
Conclusion: During the 120-week study, patients initially on sarilumab +csDMARDs who subsequently discontinued csDMARDs maintained similar clinical responses to patients who continued sarilumab +csDMARDs or received sarilumab monotherapy throughout. The AE profile was as expected, with no new safety signals.
To cite this abstract in AMA style:Curtis J, Lin Y, Thangavelu K, Stanislav M, St John G, Gómez-Centeno A, Selmi C, Huizinga T, Maldonado-Cocco J, Bukhari M, Buttgereit F. Withdrawal of Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Sarilumab Open-Label EXTEND Study: Efficacy and Safety Analysis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/withdrawal-of-conventional-synthetic-disease-modifying-antirheumatic-drugs-in-the-sarilumab-open-label-extend-study-efficacy-and-safety-analysis/. Accessed April 11, 2021.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/withdrawal-of-conventional-synthetic-disease-modifying-antirheumatic-drugs-in-the-sarilumab-open-label-extend-study-efficacy-and-safety-analysis/