O26 Effects of baseline prednisone dose on remission and disease flare in patients with giant cell arteritis treated with tocilizumab in the GiACTA trial

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Disclosures: J.H. Stone: Consultancies; Roche. Grants/research support; Roche. K. Tuckwell: Corporate appointments; Genentech. Shareholder/stock ownership; Roche, Genentech. S. Dimonaco: Corporate appointments; Roche. Shareholder/stock ownership; Roche. M. Klearman: Consultancies; Roche, Genentech. Shareholder/stock ownership; Roche, Genentech. M. Aringer: Consultancies; Roche, Chugai. D. Blockmans: Consultancies; Roche. E. Brouwer: None. M.C. Cid: Consultancies; Novartis. Other; Roche. B. Dasgupta: Consultancies; GSK, Roche, Sanofi Aventis. J. Rech: Member of speakers’ bureau; AbbVie Inc., Bristol-Myers Squibb, Celgene Corporation, Fresenius, Medicap, MSD, Pfizer Inc., Roche. Grants/research support; Bristol-Myers Squibb, Celgene Corporation. C. Salvarani: None. H. Schulze-Koops: None. G. Schett: Other; Roche, Novartis, AbbVie, BMS, Celgene, Chugai, GSK, Lilly, Sanofi, UCB. R.F. Spiera: Consultancies; GSK, Sanofi, CSL Behring. Grants/research support; Roche-Genentech, Corbus, Chemocentryx, GSK, BMS, Boehringer Ingelheinm. S.H. Unizony: Consultancies; Roche, Sanofi. N. Collinson: Corporate appointments; Roche. Shareholder/stock ownership; Roche. Background: It is not known whether the baseline (BL) glucocorticoid dose at initiation of tocilizumab (TCZ) therapy in patients with giant cell arteritis (GCA) affects rates of sustained glucocorticoid-free remission and disease flare, so this was investigated in the GiACTA trial (NCT01791153). Methods: Patients received TCZ weekly or every-other-week + 26-week prednisone taper (TCZ-QW [n = 100] or TCZ-Q2W [n = 49]) or placebo + 26-week or 52-week prednisone taper (PBO+26 [n = 50] or PBO+52 [n = 51]) for 52 weeks. Flare was defined as recurrence of GCA signs/symptoms and/or ESR ≥30 mm/h attributable to GCA requiring increased prednisone dose. Sustained remission was defined as absence of flare, normalization of CRP (<1 mg/dL), and adherence to the protocol-defined prednisone taper to week 52. All patients received prednisone during screening at a dose selected by the investigator before entry to the trial at BL. In this post hoc analysis, sustained remission rates were assessed according to BL prednisone dose. Time to first flare was assessed according to protocol-defined BL prednisone dose stratification factors (>30 mg/day or ≤ 30 mg/day). All analyses are descriptive. Results: Sustained remission was achieved by higher proportions of patients in the TCZ groups than PBO groups across the range of BL prednisone doses. Among patients with high BL prednisone doses (>30 mg/day), TCZ-treated patients had longer time to flare than patients in the PBO groups. Patients with low BL prednisone doses (≤30 mg/day) had separation between the TCZ groups and the PBO+26 group from week 12, with longer time to flare in the TCZ and PBO+52 groups than in the PBO+26 group. In the PBO+26 group, patients with low BL prednisone doses flared earlier than those with high BL doses, but there was no apparent difference in time to flare between high and low BL prednisone dose for the TCZ groups. Full results will be presented. Conclusion: Patients with GCA treated with TCZ and prednisone tapering could achieve sustained remission across a range of BL prednisone doses. Fewer patients in the TCZ groups than the PBO groups had GCA flares. Time to flare was similar for patients treated with TCZ regardless of starting prednisone dose.

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