Sophie Dimonaco

Trial of Tocilizumab in Giant-Cell Arteritis

Background Giant‐cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The effect of the interleukin‐6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant‐cell arteritis. Methods In this 1‐year trial, we randomly assigned 251 patients, in a 2:1:1:1 ratio, to receive subcutaneous tocilizumab (at a dose of 162 mg) weekly or every other week, combined with a 26‐week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. The primary outcome was the rate of sustained glucocorticoid‐free remission at week 52 in each tocilizumab group as compared with the rate in the placebo group that underwent the 26‐week prednisone taper. The key secondary outcome was the rate of remission in each tocilizumab group as compared with the placebo group that underwent the 52‐week prednisone taper. Dosing of prednisone and safety were also assessed. Results Sustained remission at week 52 occurred in 56% of the patients treated with tocilizumab weekly and in 53% of those treated with tocilizumab every other week, as compared with 14% of those in the placebo group that underwent the 26‐week prednisone taper and 18% of those in the placebo group that underwent the 52‐week prednisone taper (P<0.001 for the comparisons of either active treatment with placebo). The cumulative median prednisone dose over the 52‐week period was 1862 mg in each tocilizumab group, as compared with 3296 mg in the placebo group that underwent the 26‐week taper (P<0.001 for both comparisons) and 3818 mg in the placebo group that underwent the 52‐week taper (P<0.001 for both comparisons). Serious adverse events occurred in 15% of the patients in the group that received tocilizumab weekly, 14% of those in the group that received tocilizumab every other week, 22% of those in the placebo group that underwent the 26‐week taper, and 25% of those in the placebo group that underwent the 52‐week taper. Anterior ischemic optic neuropathy developed in one patient in the group that received tocilizumab every other week. Conclusions Tocilizumab, received weekly or every other week, combined with a 26‐week prednisone taper was superior to either 26‐week or 52‐week prednisone tapering plus placebo with regard to sustained glucocorticoid‐free remission in patients with giant‐cell arteritis. Longer follow‐up is necessary to determine the durability of remission and safety of tocilizumab. (Funded by F. Hoffmann–La Roche; ClinicalTrials.gov number, NCT01791153.)

Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial

Objectives The efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early rheumatoid arthritis (RA). Methods In a double-blind randomised controlled trial (FUNCTION), 1162 methotrexate (MTX)-naive patients with early progressive RA were randomly assigned (1:1:1:1) to one of four treatment groups: 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo and placebo+MTX (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28–erythrocyte sedimentation rate (ESR) <2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week 52. Results The intent-to-treat population included 1157 patients. Significantly more patients receiving 8 mg/kg TCZ+MTX and 8 mg/kg TCZ+placebo than receiving placebo+MTX achieved DAS28-ESR remission at week 24 (45% and 39% vs 15%; p<0.0001). The 8 mg/kg TCZ+MTX group also achieved significantly greater improvement in radiographic disease progression and physical function at week 52 than did patients treated with placebo+MTX (mean change from baseline in van der Heijde–modified total Sharp score, 0.08 vs 1.14 (p=0.0001); mean reduction in Health Assessment Disability Index, −0.81 vs −0.64 (p=0.0024)). In addition, the 8 mg/kg TCZ+placebo and 4 mg/kg TCZ+MTX groups demonstrated clinical efficacy that was at least as effective as MTX for these key secondary endpoints. Serious adverse events were similar among treatment groups. Adverse events resulting in premature withdrawal occurred in 20% of patients in the 8 mg/kg TCZ+MTX group. Conclusions TCZ is effective in combination with MTX and as monotherapy for the treatment of patients with early RA. Trial registration number ClinicalTrials.gov, number NCT01007435

Newly diagnosed vs. relapsing giant cell arteritis : Baseline data from the GiACTA trial

OBJECTIVE To report entry criteria and clinical features of patients with newly diagnosed and relapsing giant cell arteritis (GCA) enrolled in a randomized trial of tocilizumab, an interleukin-6 receptor-alpha inhibitor. METHODS Newly diagnosed GCA was defined as diagnosis ≤6 weeks before baseline. Relapsing GCA was defined as diagnosis >6 weeks before baseline with ≥2 consecutive weeks of prednisone ≥40mg/day. All patients had active GCA within 6 weeks of baseline. All statistical results are exploratory. RESULTS Of 251 patients, 119 (47%) had newly diagnosed and 132 (53%) had relapsing GCA. Mean age was 69 years in both subsets; 75% were women. Relapsing patients were heavier [difference in means (95% CI): women, 4.18kg (0.49-7.87, P = 0.027); men, 8.25kg (1.42-15.09, P = 0.019)] and had higher mean body mass index [difference in means (95% CI): women, 1.72kg/m2 (0.44-2.99, P = 0.009); men, 2.85kg/m2 (0.32-5.37, P = 0.028)]. Relapsers had higher baseline prevalence of depression (16% vs. 4%) and osteopenia/osteoporosis (33% vs. 23%, P = 0.002 and P = 0.062, respectively). At diagnosis, 67% had new-onset headaches; 34% had mouth pain/jaw claudication. One-fifth had polymyalgia rheumatica symptoms but no cranial manifestations; 62% had positive temporal artery biopsy findings; 37% were enrolled on the basis of cross-sectional imaging study findings. CONCLUSIONS Demographics of the GiACTA population reflect the epidemiologic profile of GCA. Baseline comorbidities associated with glucocorticoids were more prevalent among relapsing patients than among those with newly diagnosed disease, highlighting the need for new GCA treatment options. More than one-third of patients were enrolled based on large-vessel imaging.

Effect of tocilizumab on neutrophils in adult patients with rheumatoid arthritis: pooled analysis of data from phase 3 and 4 clinical trials

Objectives. To investigate changes in neutrophil count and occurrences of infection in RA patients treated with the IL‐6 receptor‐&agr; inhibitor tocilizumab (TCZ). Methods. Data were pooled from patients who received i.v. TCZ (4 mg/kg + MTX, 8 mg/kg ± DMARDs, 10 mg/kg) or placebo + DMARDs in phase 3/4 clinical trials, long‐term extensions or a pharmacology study. Neutrophil counts were measured routinely according to the Common Toxicity Criteria for Adverse Events grades; TCZ dosing was adjusted if necessary. Covariates associated with decreased neutrophil counts were assessed with multivariate regression analysis. Infection rates within 30 days of neutrophil count changes were calculated per 100 patient‐years of TCZ exposure. Results. In placebo‐controlled parts of trials, more TCZ‐treated than placebo‐treated patients had grade 1/2 or 3/4 neutrophil counts (TCZ: 28.2%/3.1%; placebo: 8.9%/0.2%). In placebo‐controlled trials + long‐term extensions, 4171 patients provided 16204.8 patient‐years of TCZ exposure. Neutrophil counts decreased through week 6 from baseline [mean (s.d.) change, ‐2.17 (2.16) × 109/l) and remained stable thereafter. Rates (95% CI) of serious infections within 30 days of normal [4.66 (4.31, 5.03)], grade 1/2 [2.48 (1.79, 3.34)] and 3/4 [2.77 (0.34, 10.01)] neutrophil counts were similar. Baseline neutrophil count <2 × 109/l and female gender were associated with grade 3/4 neutrophil counts [odds ratio (OR) (95% CI): 19.02 (6.76, 53.52), 2.55 (1.40, 4.66)]. Patients who stopped TCZ in response to decreased neutrophil count returned more quickly to normal levels than patients who reduced or continued their dose. Conclusion. Decreases in neutrophil counts in patients taking TCZ do not appear to be associated with serious infections and are normalized by current risk mitigation guidelines.

Transaminase Levels and Hepatic Events During Tocilizumab Treatment: Pooled Analysis of Long-Term Clinical Trial Safety Data in Rheumatoid Arthritis

To investigate liver enzyme abnormalities and hepatic adverse events (AEs) during long‐term tocilizumab treatment for rheumatoid arthritis in clinical trials.

OP0131 Optimal dose of tocilizumab for the treatment of giant cell arteritis: efficacy, safety, and exposure-efficacy analysis from giacta

Background GiACTA, a randomized, double-blind, placebo-controlled trial, evaluated the efficacy and safety of tocilizumab (TCZ), an IL-6 receptor-α inhibitor, in patients with giant cell arteritis (GCA).1,2 Objectives Secondary analyses to evaluate the differential efficacy and safety of TCZ between patients with new-onset and relapsing GCA and to evaluate the TCZ exposure-efficacy relationship at week 52 of the trial. Methods Patients aged ≥50 years with active GCA were randomly assigned 1:1:2:1 to short-course prednisone (PBO+26), long-course prednisone (PBO+52) (26-week or 52-week prednisone taper + weekly subcutaneous [SC] placebo, respectively), weekly (TCZ-QW) or every-other-week (TCZ-Q2W) SC TCZ 162 mg + 26-week prednisone taper. Subgroup analysis was performed by disease-onset status (new-onset vs relapsing) to evaluate the proportions of patients in sustained remission at week 52 and time to flare. The impact of TCZ exposure, categorized into high, medium and low tertiles, on time to flare was evaluated across all patients in all treatment arms. Results Randomization included 251 patients, 119 (47%) with new-onset and 132 (53%) with relapsing GCA, distributed evenly across groups. Higher proportions of patients achieved sustained remission in the TCZ vs placebo groups regardless of disease onset (new-onset, relapsing–TCZ-QW: 59.6%, 52.8%; TCZ-Q2W: 57.7%, 47.8%; PBO+26: 21.7%, 7.4%; PBO+52: 21.7%, 14.3%, respectively). Patients with relapsing disease at baseline were in relapse-free remission longer and thus had lower risk for flare (hazard ratio) when treated with TCZ-QW than TCZ-Q2W. Hazard ratio (99% CI) for flare vs PBO+26 was 0.23 (0.09–0.61) for TCZ-QW and 0.42 (0.14–1.28) for TCZ-Q2W; vs PBO+52 it was 0.36 (0.13–1.00) for TCZ-QW and 0.67 (0.21–2.10) for TCZ-Q2W. TCZ exposure-efficacy analysis showed that most patients in the low exposure tertile had been treated with TCZ-Q2W (80%) whereas those with medium and high exposure primarily received TCZ-QW (84% and 98%, respectively). Kaplan-Meier analysis demonstrated that patients with higher exposure benefited from a longer time to flare (Figure). Adverse events (AEs) were similar across groups. Serious AEs were reported in 15.0% TCZ-QW, 14.3% TCZ-Q2W, 22.0% PBO+26 and 25.5% PBO+52 patients; rates were similar between new-onset and relapsing patients. Conclusions The compelling treatment effect of TCZ in GCA patients as measured by sustained remission to 52 weeks was consistent regardless of disease-onset status. Duration of relapse-free remission until flare was longer in patients with higher TCZ exposure, most notably in relapsing patients treated with TCZ-QW. References Unizony SH et al. Int J Rheumatol. 2013;2013:912562. Stone JH et al. 2016 ACR/ARHP Annual Mtg; Washington, DC; A911. Disclosure of Interest J. Stone Grant/research support from: Roche, Genentech, Xencor, Consultant for: Roche, Genentech, Xencor, K. Tuckwell Shareholder of: Roche, Employee of: Roche, S. Dimonaco Employee of: Roche Products Ltd., M. Klearman Employee of: Genentech, N. Mallalieu Shareholder of: Roche, Employee of: Roche, M. Aringer Speakers bureau: Roche, Chugai, D. Blockmans: None declared, E. Brouwer Consultant for: Roche, M. Cid Speakers bureau: Roche, Novartis, B. Dasgupta Speakers bureau: Roche, GlaxoSmithKline, J. Rech: None declared, C. Salvarani: None declared, G. Schett Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Chugai, GlaxoSmithKline, Lilly, Novartis, Roche, Sanofi, UCB, H. Schulze-Koops: None declared, R. Spiera Grant/research support from: Roche, Genentech, Consultant for: Roche, Genentech, S. Unizony: None declared, N. Collinson Employee of: Roche Products Ltd.

SAT0531 Acute phase reactant levels and prednisone doses at disease flare in patients with giant cell arteritis: prospective data from the giacta trial

Background The relationship between acute phase reactant levels and giant cell arteritis (GCA) disease flares is not known, particularly in the era of interleukin-6 receptor blockade with tocilizumab (TCZ). Prednisone doses at which GCA flares can occur have not been studied thoroughly in prospective clinical trials. Objectives Investigate prednisone doses and acute phase reactant levels at the time of disease flare in patients with GCA. 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). The last CRP and ESR values before first disease flare were used if values on the day of first flare were missing. Analyses are descriptive and were performed post hoc. 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.1 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) were associated 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 the time of disease flare in the combined TCZ and combined PBO groups were 5.5 (0.0–310.0) and 9.0 (0.0–55.0) mg/day, respectively. Among 149 patients in the TCZ groups, 10 (7%) had disease flares while receiving prednisone doses greater than 10 mg/day, accounting for 28% of all disease flares in the TCZ groups. Among 101 patients in the PBO groups, 23 (23%) had disease flares while receiving prednisone doses>10 mg/day, accounting for 39% of all disease flares in the PBO groups. Thus, 33 of the 95 disease flares in GiACTA (35%) occurred while the patient was receiving ≥10 mg/day prednisone.Abstract SAT0531 – Table 1 Prednisone doses and acute phase reactants at GCA flare Conclusions 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. Reference [1] Stone JH, et al. N Engl J Med2017;377:317–328. Acknowledgements This study was sponsored by F. Hoffmann-La Roche Ltd. Disclosure of Interest J. Stone Grant/research support from: Roche, Genentech, Xencor, Consultant for: Roche, Genentech, Xencor, K. Tuckwell Shareholder of: Roche, Employee of: Genentech, S. Dimonaco Employee of: Roche, M. Klearman Employee of: Genentech, M. Aringer Consultant for: Chugai, Roche, Speakers bureau: Chugai, Roche, D. Blockmans: None declared, E. Brouwer Grant/research support from: Roche, M. C. Cid Consultant for: Roche, Novartis, Boehringer-Ingelheim, B. Dasgupta Consultant for: Roche, GlaxoSmithKline, J. Rech: None declared, C. Salvarani: None declared, H. Schulze-Koops: None declared, G. Schett Grant/research support from: AbbVie, BMS, Celgene, Chugai, GSK, Lilly, Novartis, Roche, Sanofi, UCB, Consultant for: AbbVie, BMS, Celgene, Chugai, GSK, Lilly, Novartis, Roche, Sanofi, UCB, R. Spiera Grant/research support from: Roche/Genentech, Consultant for: Roche/Genentech, S. H. Unizony: None declared, N. Collinson Employee of: Roche

SAT0550 Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial

Background Superior rates of sustained glucocorticoid (GC)–free remission were shown in patients with giant cell arteritis (GCA) treated with weekly or every-other-week (wk) subcutaneous tocilizumab (TCZ) 162 mg +26 wk GC taper for 52 wks compared with placebo +26 wk or 52-wk GC taper (PBO +26 or PBO +52) in the GiACTA trial. Statistically significant improvements in SF-36 Physical Component Summary (PCS) scores were reported for weekly TCZ vs PBO +52 and in patient-reported global assessment of disease activity for both TCZ groups vs both PBO groups.1 Objectives To report further analysis of patient-reported outcomes (PROs) in GiACTA. Methods Analyses of SF-36 PCS and Mental Component Summary (MCS), SF-36 domains, and Functional Assessment of Chronic Illness Therapy (FACIT)–fatigue compared patients treated with weekly TCZ (n=100) vs PBO +26 (n=50; not shown) or PBO +52 (n=51) for 52 wks based on reported data, including all responders as well as patients with post-escape data following flare. Results Improvements in SF-36 PCS and MCS scores, 6 of 8 SF-36 domains, and FACIT–Fatigue at wk 52 were significantly greater with weekly TCZ vs PBO +52 (p<0.01) (table 1, figure 1). At wk 52, mean scores met or exceeded age/gender (A/G)–matched normative scores in the weekly TCZ group; higher proportions of patients reported scores exceeding A/G norms in SF-36 PCS and MCS, all SF-36 domains, and FACIT-Fatigue (Table) compared with PBO groups. The median cumulative prednisone dose over 52 wks was lower with weekly .TCZ (18620 mg) vs PBO +26 (3296.0 mg) or PBO +52 (3817.5 mg) (p<0.01). Table. Change From Baseline to Wk 52; mean score (% ≥A/G norms) Weekly TCZ+26n=100 PBO+52n=51 Baseline Wk 52 LSM Δ Baseline Wk 52 LSM Δ PROs (A/G norms) PtGA 43.61 24.36 –17.14 47.78 35.44 –7.56 FACIT-Fatigue (40.0) 36.05 (43.4) 42.08(73.8) 5.30a 31.42 (32.7) 32.62 (35.6) –0.42 SF-36 PCS(50.0) 43.10 (23.7) 47.75 (43.5) 4.18a 41.12 (20.4) 41.24 (22.2) –0.40 SF-36 MCS (50.0) 42.77 (33.0) 51.64 (60.0) 8.10a 40.45 (34.7) 44.86 (40.0) 1.89 SF-36 Domains (A/G norms) Physical function (67.56) 69.10 (60.0) 78.28 (78.8) 6.83 59.40 (42.0) 65.44 (55.6) 2.68 Role physical (69.44) 49.56 (25.0) 73.75 (56.5) 20.64a 45.38 (28.0) 53.89 (33.3) 4.46 Bodily pain (64.52) 61.93 (41.0) 73.25 (65.9) 10.89a 55.67 (34.7) 56.27 (31.1) –2.87 General health (66.49) 55.00 (25.8) 65.81 (57.6) 9.06a 55.69 (36.0) 52.29 (22.0) –4.05 Vitality(58.65) 50.19 (33.3) 66.13 (68.2) 15.69a 42.38 (28.0) 49.17 (33.3) 3.53 Social function (81.49) 64.25 (29.0) 84.71 (63.5) 17.35a 63.00 (40.0) 67.5040.0 2.34 Role emotional (82.08) 66.38 (43.0) 82.45 (62.4) 13.37 60.33 (36.0) 69.63 (46.7) 3.53 Mental health (77.16) 64.04 (32.3) 77.94 (52.9) 12.54a 59.10 (24.0) 66.33 (31.1) 3.13 LSMΔ, least squares mean change from baseline to wk 52; PtGA, patient-reported global assessment. All analyses based on observed data (post-escape data included). ap <0.01 vs PBO+52.Abstract SAT0550 – Figure 1 SF-36 Domains at BL and Week 52. **p<0.01 vs PBO+52. A/G, age/gender; BL, baseline. Conclusions Patients with GCA treated with weekly TCZ 162 mg and a 26-wk GC taper reported statistically significantly greater improvements in health-related quality of life and fatigue that exceeded normative values compared with those receiving 52-wk GC taper alone, in part ascribed to lower steroid doses. Reference [1] Stone JH, et al. N Engl J Med2017;377:317–328. Disclosure of Interest V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Celltrion, CORRONA, Crescendo, EMD Serono, Genentech/Roche, GSK, Janssen, Lily, Merck, Novartis, Pfizer, Protagen, Regeneron, Samsung, Sandoz, Sanofi, UCB, S. Dimonaco Employee of: Roche, K. Tuckwell Shareholder of: Roche, Employee of: Roche, M. Klearman Employee of: Genentech, N. Collinson Employee of: Roche, J. H. Stone Grant/research support from: Roche, Genentech, Xencor, Consultant for: Roche, Genentech, Xencor

FRI0248 Baseline Data on Patients in Giacta (Tocilizumab in Giant Cell Arteritis)

Background GiACTA is a randomized, double-blind, placebo-controlled trial of an interleukin-6 receptor antagonist (tocilizumab [TCZ]) in giant cell arteritis (GCA) (ClinicalTrials.gov NCT01791153). 200 of the target 250 pts have been enrolled; recruitment is ongoing, making it the largest GCA trial to date. The trial hypothesis is that TCZ is effective at achieving sustained, corticosteroid (CS)-free remissions. Objectives To report baseline characteristics of the first 200 pts enrolled and to compare characteristics of pts with new-onset GCA (n=95) to those with relapsing GCA at enrollment (n=105). Methods Major inclusion criteria: age ≥50 y, historical ESR ≥50 mm/h or CRP ≥2.45 mg/dL, unequivocal cranial GCA symptoms or polymyalgia rheumatic (PMR), and positive temporal artery biopsy (TAB) or large-vessel imaging. The trial includes 4 arms: TCZ 162 mg SC QW plus 6-mo prednisone taper; TCZ SC 162 mg Q2W plus 6-mo prednisone taper; prednisone only, 6-mo taper; and prednisone only, 12-mo taper. Selection of the initial prednisone dose (between 20 mg/d and 60 mg/d) is at investigator discretion. The CS taper is blinded at doses <20 mg/d. Data are from a live study database and are subject to change. Results The mean age among pts enrolled thus far is 69 y (range, 53-84); 75% are women. At entry, 95 (48%) had new-onset GCA and 105 (52%) had relapsing disease. Baseline comorbid conditions include hypertension (53%) and diabetes (12%). There have been 2 screen failures for every 5 pts enrolled. The most common reason for screen failure was insufficient evidence to support the protocol-defined diagnosis of GCA. 57% had positive TAB, and 43% were enrolled based on positive cross-sectional imaging studies. 10% had negative TAB but positive imaging study results. PMR symptoms were present in 33% of relapsing pts but only in 10% with new-onset GCA. The percentages with persistent cranial arteritis symptoms at baseline (following prednisone after initial suspicion of GCA) were 34% among new-onset pts and 44% among relapsing pts. The mean daily prednisone dose at entry for pts with new-onset GCA was 40 mg compared with 30 mg for those with relapsing disease. Although 20% of new-onset pts entered on 60 mg/d prednisone, only 4% of those with relapsing disease entered at that dose. Conversely, 36% of relapsing pts entered at the minimum daily prednisone dose – 20 mg/d – but only 12% of those with new-onset disease entered at that dose. The mean baseline BMI for pts with relapsing disease (n=102) was slightly higher than that of new-onset pts (n=92): 26.7±5.3 vs 25.1±3.9. At the time of this analysis, 54 pts (24 new onset, 30 relapsing) had received escape prednisone for disease flares. Conclusions Demographic features of the GiACTA population reflect the characteristic epidemiologic profile of GCA. A substantial proportion of pts were enrolled based on large-vessel imaging findings rather than positive TAB. Pts with relapsing disease at entry may be more likely to have PMR at baseline and to enter at lower prednisone doses yet have higher baseline BMIs. This is likely a result of previous CS treatment. More than 25% of pts enrolled to date have received escape therapy. Therefore, if TCZ is effective as a steroid-sparing agent in GCA, the trial protocol under conduct now should have a robust ability to prove this hypothesis. Disclosure of Interest K. Tuckwell Employee of: Roche, N. Collinson Employee of: Roche, M. Klearman Shareholder of: Roche, Employee of: Genentech, S. Dimonaco Employee of: Roche, J. Stone Grant/research support from: Roche