Genentech to Highlight Actemra and Rituxan Data at EULAR Annual Congress

Various new data on Genentech’s Actemra (tocilizumab) and Rituxan (rituximab) will be presented at the 2017 European League Against Rheumatism (EULAR) annual congress in Madrid, June 14-17. The data highlight the continued safety and efficacy of both Actemra and Rituxan in patients with rheumatic diseases and vasculitis, as well as unmet needs in lupus nephritis.

Genentech continues to study treatments for autoimmune diseases with significant unmet medical need. The company is conducting a Phase III clinical study, called focuSSced (NCT02453256), investigating the use of Actemra in patients with systemic sclerosis. Additionally, Genentech is currently enrolling sites and patients in a Phase II clinical trial called NOBILITY (NCT02550652) to study obinutuzimab, a CD20-directed cytolytic antibody, in adults with lupus nephritis.

Recently, U.S. FDA granted breakthrough therapy designation to Rituxan in pemphigus vulgaris, a rare, serious and life-threatening condition, and approved Actemra for the treatment of giant cell arteritis (GCA), a chronic and severe autoimmune condition. At EULAR, the pivotal Phase III GiACTA data that led to Actemra’s approval for GCA will be presented for the first time at a rheumatology congress outside of the United States.

Below is an agenda and description of what their innovate presentation will cover:

Actemra Data: Optimal Dose of Tocilizumab for the Treatment of Giant Cell Arteritis: Efficacy, Safety, and Exposure-Efficacy Analysis from Giacta

(Thursday, June 15th at 10:30am, South Auditorium) (Oral Presentation) (OP0131)

• Presenter: Dr. John Stone
• The compelling treatment effect of Actemra in giant cell arteritis (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 Actemra exposure, most notable in relapsing patients treated with Actemra-QW.
• This will be the first presentation of GiACTA at a rheumatology congress outside of the U.S.
• The GiACTA data led to Actemra becoming the first and only FDA-approved treatment for GCA

Long-Term Safety of Tocilizumab from Large Clinical Trial and Postmarketing Populations

(Thurdsay, June 15^th at 11:30am, Hall 8) (Oral Presentation) (OP0105)

• Presenter: Shalini Mohan, MD, Genentech
• The safety profile of Actemra in the current analysis, which includes information about safety events from 12 clinical trials and their LTEs and across seven years of real-world postmarketing reports encompassing ≈ 600,000 patients, was consistent with previous safety reports. These findings are consistent with the previously reported profile of Actemra and indicate that there is no evidence of increased safety risk with increasing exposure to Actemra. 

Evaluation of a Dosing Regimen for Tocilzumab in Patients Younger than Two Years of Age with Systemic Juvenile Idiopathic Arthritis 

(Thursday, June 15^th at 2:35pm, North Convention Center) (Oral Presentation) (OP0197)

• Presenter: Navita L. Mallalieu, Clinical Director, Roche
• This study provides evidence that Actemra is effective in sJIA pts <2 years of age, achieves PK and efficacy similar to those demonstrated previously in older pts, and has a similar AE safety profile, but there was a higher incidence of serious hypersensitivity events and suspected MAS.

Sustained Response Following Discontinuation of Methotrexate in Patients with RA with Sub-Q Tocilizumab, Results from a Randomized Controlled Trial (Comp-Act) 

(Friday, June 16^th at 11:30am, Poster Area) (Poster Tour) (FRI0222)

• Presenter: Joel Kremer, Albany Medical College and The Center for Rheumatology
• The results in this study demonstrated that patients receiving Actemra-COMBO who achieve low disease activity can continue MTX and maintain disease control. 

Clinical Remission in subjects with RA treated with Sub-Q Tocilizumab as Monotherapy or in Combination with Methotrexate or Other Synthetic Dmards: a Real World Clinical Trial.

(Saturday, June 17^th at 10:15am, Poster Area) (Poster Tour) (SAT0183)

• Presenter: Raimon Sanmarti, Hospital Clinic, Barcelona, Spain
• In the real world setting, treatment with Actemra-SC 162 mg weekly in patients with active RA is associated with sustained clinical remission of approximately 50 percent regardless it is administered as monotherapy or in combination with a sDMARD. The safety profile of Actemra-SC was consistent with previous studies of Actemra-SC and Actemra-IV.

Actemra/Rituxan Data:

Comparative Effectiveness of Abatcept, Rituximab, Tocilzumab and TFN1 Biological Dmards in RA: Results from the Nationwide Swedish Register. 

(Friday, June 16^th, All Day, Poster Area) (Poster Tour) (FRI0213)

• Presenter: Thomas Frisell, Karolinska Institutet, Stockholm, Sweden
• Despite channeling of older and sicker individuals to non-TNFi-bDMARDs, treatment outcomes were in general better in these groups, particularly for Actemra and Rituxan.

Rituxan Data:

Safety Following Initiation of Rituximab in Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA): Interm Analysis of the Rituximab in ANCA-Associated Vasculitis Registry (Raver) 

(Thursday, June 15^th at 1:00pm, Poster Area) (THU0301)

• Presenter: Dr. John Niles, Massachusetts General Hospital, Boston, MA
• In patients with GPA/MPA treated with Rituxan, SAEs were not increased compared with comparable cohorts of patients with renal involvement. Safety events did not increase with Rituxan treatment. These results are consistent with the known safety profile of Rituxan and provide preliminary long-term, practice-level safety data for Rituxan in GPA/MPA.

Repeated Rituximab Infusions for the Therapy of RA is not Associated with Increased Rates of Serious Infections 

(Saturday, June 17^th, All Day, Poster Area) (Poster Tour) (SAT0196)

• Presenter: Dimitrios A. Pappas, Columbia University, Corrona LLC
• Retreatment with Rituxan infusions was not associated with a higher rate of SIEs in this study. Patients who experienced an SIE had a higher prevalence of risk factors for infections. 

Lupus Nephritis Data:

FRI0285: Lupus Nephritis is Associated with INcreased Rates of Hospitalization an In-Hospital Mortality Compared with Non-Renal Lupus and Matched Controls: An Analysis of Insurance Claims Data. 

(Friday, June 16^th, All Day, Poster Area) (Poster Tour) (FRI0285)

• Presenter: Katherine Belendiuk, Research Scientist, Genentech
• A systemic lupus erythematosus diagnosis was associated with a higher burden of comorbidities and higher rates of hospitalizations and in-hospital mortality than patients without an autoimmune condition. Patients with lupus nephritis had the highest burden of comorbidities and rates of hospitalizations and in-hospital mortality.