272 Acute phase reactant levels and prednisone doses at disease flare in patients with giant cell arteritis: prospective data from the GiACTA trial

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Background: This post-hoc analysis investigated the link between acute phase reactant levels, prednisone doses, and giant cell arteritis (GCA) disease flares in the GiACTA trial (NCT01791153) as these have not been studied thoroughly in prospective clinical trials. Methods: Secondary analyses of prednisone doses, C-reactive protein (CRP) levels, and erythrocyte sedimentation rate (ESR) were performed for patients who experienced GCA flare after achieving remission during 52 weeks of treatment with TCZ-weekly or -every-other-week + 26-week prednisone taper (TCZ-QW or TCZ-Q2W) or placebo + 26-week or 52-week prednisone taper (PBO+26 or PBO+52). Analyses are descriptive and were performed post-hoc. Prednisone doses and acute phase reactants at GCA flare Percentage based on N. Normal ≤10 mg/L. Percentage based on n who experience flare. Normal <30 mm/h. en = 24 Results: GCA flare after remission was reported in 23% (23/100) of TCZ-QW patients, 26% (13/50) of TCZ-Q2W patients, 68% (34/50) of PBO+26 patients, and 49% (25/51) of PBO+52 patients. Median CRP levels and ESR at the time of flare were lower in the TCZ groups than in the PBO groups (Table). In the TCZ groups, 92% (33/36) of flares were associated with normal CRP levels (≤1 mg/dL) and 89% (32/36) with normal ESR values (<30 mm/h). In the PBO groups, 34% (20/59) of flares were associated with normal CRP values and 31% (18/59) with normal ESR. Median (min-max) prednisone doses at disease flare were 5.5 (0.0-310.0) and 9.0 (0.0-55.0) mg/day in the combined TCZ and PBO groups respectively. Among 149 patients in the TCZ groups, 10 (7%) had disease flares while receiving prednisone doses >10 mg/day. Among 101 patients in the PBO groups, 23 (23%) had disease flares while receiving prednisone doses >10 mg/day, thus 33 of the 95 disease flares in GiACTA (35%) occurred while the patient was receiving ≥10 mg/day prednisone. Conclusion: Acute phase reactants are not reliable correlates of disease flare in TCZ-treated patients, but approximately one-third of all PBO + prednisone patients also had normal acute phase reactants at the time of disease flare. Median prednisone dose at the time of disease flare for TCZ-treated patients was numerically lower than that of patients treated with PBO + prednisone. One-third of all disease flares in GiACTA occurred while the patient was receiving >10 mg/day prednisone. Disclosures: J.H. Stone: Consultancies; Roche, Genentech, Xencor. Grants/research support; Roche, Genentech, Xencor. K. Tuckwell: Corporate appointments; Genentech. Shareholder/stock ownership; Roche. S. Dimonaco: Corporate appointments; Roche. Shareholder/stock ownership; Roche. M. Klearman: Corporate appointments; Genentech. M. Aringer: Consultancies; Roche, Chugai. D. Blockmans: Consultancies; Roche. E. Brouwer: Grants/research support; Roche. M.C. Cid: Consultancies; Roche, Novartis, Boehringer-Ingelheim. B. Dasgupta: Consultancies; Roche, GlaxoSmithKline. J. Rech: None. C. Salvarani: None. H. Schulze-Koops: None. G. Schett: Consultancies; AbbVie, BMS, Celgene, Chugai, GSK, Lilly, Novartis, Roche, Sanofi, UCB. Grants/research support; Abbvie, BMS, Celgene, Chugai, GSK, Lilly, Novartis, Roche, Sanofi, UCB. R. Spiera: Consultancies; Roche/Genentech. Grants/research support; Roche/Genentech. S.H. Unizony: Consultancies; Roche, Sanofi. N. Collinson: Corporate appointments; Roche.

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