Background/Purpose:

Increased serum lipid levels in patients being treated with tocilizumab (TCZ) is known from several clinical trials^1,2. It is not known whether additional methotrexate (MTX) alters TCZ’s influence on serum lipid levels.

Methods:

Statistical analyses were performed with data from the OPTIMISE trial (EUDRACT No. 2011-001863-39) running in Austria from January 2012 to August 2013. Seventy-seven patients with mild to moderate rheumatoid arthritis (RA) and inadequate response (DAS28 >2.6 and ≤4.5) to a stable dose of MTX (15 – 25 mg/week) were enrolled and received three infusions of TCZ (8 mg/kg) iv every 4 weeks plus MTX. Patients (n = 65) achieving good or moderate EULAR response at week 12 were randomized into Group A (TCZ 8 mg/kg plus MTX) or Group B (TCZ 8 mg/kg plus MTX placebo). Blood was drawn every four weeks and, among other blood parameters, also cholesterol (total, HDL, LDL) and triglycerides were measured. Statistical comparisons were done between the three time points: week 0 (baseline), week 12 (end of therapy TCZ plus MTX) and week 24 (end of TCZ plus MTX or TCZ plus MTX placebo).

Results:

A moderate increase was found in total cholesterol (median of both groups together; 201 mg/dl at baseline, 223 in week 12, 221 in week 24), HDL (63 mg/dl at baseline, 69 in week 12, 66 in week 24) and LDL (118 mg/dl at baseline, 132 in week 12, 130 in week 24). The two groups differed significantly between baseline and week 12. Triglyceride levels did not change significantly. Comparison of the amount of lipid level change from week 12 to week 24 (TCZ plus MTX versus TCZ plus MTX placebo) between the groups was not significant. Only one difference (increase baseline to week 24) revealed a borderline (p = 043; t test) statistical significance between groups.

Conclusion:

RA patients with mild to moderate disease activity show a distinct change in cholesterol levels under successful TCZ and MTX therapy. These lipid levels remained unchanged between week 12 and 24 under continuous therapy with TCZ alone or in combination with MTX. It is unclear as to whether the increase in cholesterol (total, HDL, LDL) is a sign of disease control or a direct effect of TCZ on lipid syntheses.

Literature:

1.  Souto A et al. Lipid profile changes in patients with chronic inflammatory arthritis treated with biologic agents and tofacitinib in randomized clinical trials: a systematic review and meta-analysis Arthritis Rheumatol 2015;67:117-27

2.  Kawashiri SY et al. Effects of the anti-interleukin-6 receptor antibody, tocilizumab, on serum lipid levels in patients with rheumatoid arthritis. Rheumatol Int. 2011;31:451-6

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/increased-serum-lipids-under-tocilizumab-is-not-influenced-by-methotrexate/