Pharmacokinetics and Pharmacodynamics of Tocilizumab in Combination With Prednisone Tapering in Patients With Giant Cell Arteritis: 3-Year Results From a Randomized Controlled Phase 3 Trial
Patients in clinical remission at the end of part 1 of GiACTA could stop treatment. GCA treatment administered during part 2 was at the investigator's discretion. Tocilizumab exposure and pharmacodynamic biomarkers were similar between patients who restarted weekly tocilizumab treatment after dosing interuption and those who recieved double-blind weekly tocilizumab in part 1, suggesting there were no negative effects for patients who achieved remission and stopped tocilizumab treatment and restarted it if they experienced GCA flare. Patients who experienced flare while recieving tocilizumab had low CRP levels and ESR, confirming these are not reliable markers of flare in GCA patients treated with tocilizumab.
Impact of Glucocorticoid Tapering on Markers of Bone Metabolism in Patients With Rheumatoid Arthritis Who Achieved Low Disease Activity or Remission on Tocilizumab: Exploratory Analysis From A Randomized Controlled Trial
Exploratory bone and cartilage biomarker analysis of the SEMIRA trial of patients with rheumatoid arthritis low disease activity treated with tocilizumab plus either continued glucocorticoids or glucocorticoid tapering, showed a trend toward an anabolic window with potential for endogenous bone recovery or reversibility of exogenous glucocorticoid-induced bone loss and reduced cartilage degradation with glucocorticoid tapering.
Risk Factors for Treatment Failure in Patients With Giant Cell Arteritis Treated With Tocilizumab Plus Prednisone Versus Prednisone Alone
This multivariate analysis of data from the GiACTA trial of tocilizumab in giant cell arteritis identified that patients treated with prednisone alone were more likely to experience treatment failure than those treated with tocilizumab plus prednisone. Females were more likely to experience treatment failure than males when treated with prednisone alone but not if they received tocilizumab as well. Worse quality of life, lower prednisone dose, and some clinical symptoms were associated with treatment failure in tocilizumab-treated patients, suggesting these factors may be considered for individual treatment plans.
A Phase 2 Randomized, Controlled Study of Obinutuzumab with Mycophenolate and Corticosteroids in Proliferative Lupus Nephritis
NOBILITY is a Phase 2, randomized, controlled clinical trial to evaluate the efficacy and safety of obinutuzumab in lupus nephritis. Patients with Class III/IV lupus nephritis were randomized 1:1 to receive either obinutuzumab or placebo, and all patients received mycophenolate and a corticosteroid taper. Outcomes presented include renal response at week 52 (primary endpoint), overall renal response, modified complete renal response, and safety; results through week 76 are reported.
EULAR 2019 oral: Preservation of Lung Function Observed in a Phase 3 Randomized Controlled Trial of Tocilizumab for the Treatment of Early Systemic Sclerosis
Patients with early SSc received subcutaneous tocilizumab or placebo treatment for 48 weeks in this double-blind randomized controlled phase 3 trial (focuSSced). The primary skin sclerosis endpoint was not met. However, patients treated with tocilizumab experienced clinically meaningful preservation of lung function, which was supported by lung fibrosis score results.
Roche immunology pipeline and mode of action
Overview of the Roche immunology pipeline and modes of action
EULAR 2019 oral: Randomized Controlled 24-Week Trial Evaluating the Safety and Efficacy of Blinded Tapering Versus Continuation of Long-Term Prednisone (5 mg/d) in Patients With Rheumatoid Arthritis Who Achieved Low Disease Activity or Remission on ▼Tocilizumab
In the SEMIRA trial of patients with rheumatoid arthritis low disease activity treated with ▼tocilizumab plus conventional synthetic disease-modifying antirheumatic drugs and either continued glucocorticoids (5 mg/day) or a glucocorticoid tapering schedule (from 5 mg/day to 0 mg/day), continued glucocorticoid treatment was superior to tapered glucocorticoids for maintaining disease control. However, almost two-thirds of patients who discontinued glucocorticoids did not experience flare and maintained low disease activity, suggesting that rheumatoid arthritis patients achieving low disease activity should be considered for glucocorticoid tapering and discontinuation.
Vasculitis presentation 2019: Risk Factors for Treatment Failure in Patients With Giant Cell Arteritis Treated With Tocilizumab Plus Prednisone Versus Prednisone Alone
Risk factors for treatment failure (failure to achieve sustained remission) were investigated in a post hoc univariate analysis of data from the GiACTA trial of tocilizumab versus placebo in patients with giant cell arteritis (GCA). The risk for treatment failure was higher for women than men with GCA treated with prednisone alone but this effect of gender was not evident for patients who received tocilizumab added to prednisone treatment. Impaired health-related quality of life at baseline was predictive of treatment failure in tocilizumab-treated patients and patients who received placebo plus prednisone.
Vasculitis poster 2019: Risk of Potential Glucocorticoid-related Adverse Events in Patients with Giant Cell Arteritis: Results from a US-based Electronic Health Records Database
This retrospective, observational study used electronic health records of US patients with giant cell arteritis (GCA) who received oral glucocorticoids (OGCs) within 6 months of GCA diagnosis between 2009 and 2015. Potential adverse events (AEs) were assesed during the 12 months post index (date of first OGC prescription) and descriptively summarized across 4 quartiles of OGC daily dose.
Vasculitis poster 2019: 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
The effects of baseline prednisone doses on disease flare and sustained remission in patients from the GiACTA trial of tocilizumab versus placebo in patients with giant cell arteritis (GCA) were investigated in post hoc analyses. Fewer patients who received tocilizumab experienced GCA flare than those who received placebo and most patients who experienced flare were receiving concomitant glucocorticoids at the time of flare. Tocilizumab-treated patients achieved sustained remission across the range of baseline prednisone doses (20 – 60 mg/day) and had similar time to flare regardless of baseline prednisone dose.