Effects of Baseline Prednisone Dose on Remission and Disease Flare in Patients with Giant Cell Arteritis Treated with Tocilizumab in a Phase 3 Randomized Controlled Trial

John H. Stone¹, Katie Tuckwell², Sophie Dimonaco³, Micki Klearman², Martin Aringer⁴, Daniel Blockmans⁵, Elisabeth Brouwer⁶, Maria C. Cid⁷, Bhaskar Dasgupta⁸, Juergen Rech⁹, Carlo Salvarani¹⁰, Hendrik Schulze-Koops¹¹, Georg Schett¹², Robert F. Spiera¹³, Sebastian H. Unizony¹⁴ and Neil Collinson³, ¹Rheumatology (Medicine), Massachusetts General Hospital, Harvard Medical School, Boston, MA, ²Genentech, Inc., South San Francisco, CA, ³Roche Products Ltd, Welwyn Garden City, United Kingdom, ⁴Abteilung für Rheumatologie, Dresden, Germany, ⁵University Hospital Gasthuisberg, Leuven, Belgium, ⁶University of Groningen University Medical Center, Groningen, Netherlands, ⁷University of Barcelona, Barcelona, Spain, ⁸Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, United Kingdom, ⁹Universitätsklinikum Erlangen, Erlangen, Germany, ¹⁰Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy, ¹¹Ludwig-Maximilians-University, Munich, Germany, Munich, Germany, ¹²Friedrich-Alexander-Universität Erlangen, Nürnberg und Universitätsklinikum Erlangen, Erlangen, Germany, ¹³Hospital for Special Surgery, New York, NY, ¹⁴Massachusetts General Hospital, Harvard Medical School, Boston, MA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: giant cell arteritis and tocilizumab

Session Information

Date: Tuesday, October 23, 2018

Title: Vasculitis Poster III: Immunosuppressive Therapy in Giant Cell Arteritis and Polymyalgia Rheumatica

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Adding tocilizumab (TCZ) to tapered prednisone treatment for patients (pts) with giant cell arteritis (GCA) leads to improved rates of sustained glucocorticoid-free remission.¹ It is not known, however, whether the glucocorticoid dose at initiation of TCZ affects disease control. We investigated sustained remission and disease flare according to baseline (BL) prednisone doses in pts with GCA treated with TCZ or placebo (PBO) and scheduled prednisone tapering in the GiACTA trial.¹

Methods: Pts 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.¹ 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 pts 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 and 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 pts in the TCZ groups than the PBO groups across the range of BL prednisone doses (Figure 1). Figure 2 shows Kaplan-Meier analysis of time to flare. Among pts with high BL prednisone doses (>30 mg/day), TCZ-treated pts had longer time to flare than pts in the PBO groups. Pts 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, pts with low BL prednisone doses flared earlier than pts 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.

Conclusion: Pts with GCA treated with TCZ and prednisone tapering could achieve sustained remission across a range of BL prednisone doses. Fewer pts in the TCZ groups than the PBO groups had GCA flares. Time to flare was similar for pts treated with TCZ regardless of starting prednisone dose. Reference: 1. Stone JH et al. N Engl J Med. 2017;377: 317-328. Acknowledgment: GiACTA investigators. Medical writing: Sara Duggan, PhD, funded by F. Hoffmann La-Roche Ltd.

Disclosure: J. H. Stone, Roche, 2,Roche, 5; K. Tuckwell, Roche/Genentech, 1,Genentech, Inc., 3; S. Dimonaco, Roche, 1,Roche, 3; M. Klearman, Roche/Genentech, 1,Roche/Genentech, 5; M. Aringer, Roche, Chugai, 5,Roche, Chugai, 8; D. Blockmans, None; E. Brouwer, None; M. C. Cid, Roche, 9,Novartis, 5; B. Dasgupta, Roche, GSK, Sanofi Aventis, 5; J. Rech, Bristol-Myers Squibb, 2, 8,Celgene Corporation, 2, 8,AbbVie Inc., 8,Fresenius, 8,Medicap, 8,MSD, 8,Pfizer, Inc., 8,Roche, 8; C. Salvarani, None; H. Schulze-Koops, None; G. Schett, AbbVie, BMS, Celgene, Chugai, GSK, Lilly, Novartis, Roche, Sanofi, UCB, 9; R. F. Spiera, Roche-genetech, 2,Corbus, 2,chemocentryx, 2,GSK, 2,BMS, 2,Boehringer Ingelheinm, 2,GSK, 5,Sanofi, 5,CSL Behring, 5; S. H. Unizony, None; N. Collinson, Roche, 1,Roche, 3.

To cite this abstract in AMA style:

Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schulze-Koops H, Schett G, Spiera RF, Unizony SH, Collinson N. Effects of Baseline Prednisone Dose on Remission and Disease Flare in Patients with Giant Cell Arteritis Treated with Tocilizumab in a Phase 3 Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/effects-of-baseline-prednisone-dose-on-remission-and-disease-flare-in-patients-with-giant-cell-arteritis-treated-with-tocilizumab-in-a-phase-3-randomized-controlled-trial/. Accessed .

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