Wednesday, 13 Dec 2017

You are here

Actemra - First FDA Approved Drug for Giant Cell Arteritis

Genentech announced on May 22 that subcutaneous (sc) tocilizumab (TCZ) was granted FDA approval for Giant Cell Arteritis (GCA) – also known as temporal arteritis.

TCZ was shown to be effective in the landmark GiACTA study presented at the Annual ACR meeting in November 2016. The FDA gave the drug Breakthrough Therapy Designation In October 2016 and granted a priority review for this indication in January 2017.

Actemra (IV and sc) is currently approved for use in moderate to severely active rheumatoid arthritis. The IV formulation iwas also FDA approved for use in polyarticular juvenile idiopathic arthritis (JIA) and systemic JIA (over age 2 yrs.). The approval of sc TCZ for GCA becomes the sixth FDA approval for TCZ since its initial approval in 2010.

The new indication for GCA is based on the phase III GiACTA study that demonstrated that TCZ with steroids was superior to steroid therapy alone.  GiACTA was a 52-week, Phase randomized, double-blind, placebo-controlled trial that included 251 patients, from 14 countries, with either newly diagnosed or relapsing GCA.  All patients received initial prednisone (that was tapered over 26 or 52 weeks); half were on placebo and the other half received TCZ 162 mg (either weekly or every other week) in addition to prednisone. The primary endpoint was sustained remission from week 12 to week 52.

Patients treated with TCZ had sustained remission in 56 % of patients receiving weekly TCZ and 53% receiving every-other week dosing (compared to 18% of placebo treated patients at 52 weeks). Time to first flare following clinical remission was significantly later in both TCZ treated groups compared to placebo. Impressively, 56% of TCZ patients were in steroid-free disease remission at one year, compared to 14% for those on steroid only taper regimen. 

Thus TCZ had a significant steroid-sparing effect in this study.  No new safety signals were observed at the time of this analysis. Adverse events were similar to those seen in previous TCZ developmental clinical studies. The rate is serious infections in GiACTA was events was 9.7 per 100 patient years in the Actemra weekly group and 4.4 per 100 patient years in the every other week Actemra group. There were no bowel perforations noted in the trial.

GiACTA is a 3 year study and the open-label portion is ongoing.

The package insert (http://buff.ly/2qet87H) states that sc TCZ is indicated for use in adult patients with GCA.  The recommended dosing is 162 mg given once weekly as a subcutaneous injection, in combination with a tapering course of glucocorticoids.  Every other week (162 mg dose) may be prescribed based on clinical considerations. The use of TCZ in GCA comes with the same warnings and precautions seen with other (e.g., RA) indications, including warnings about serious infections, GI perforations, the need for monitoring neutrophil counts, hepatic enzymes and lipids.  Patients should be screened for TB infection and live vaccines should be avoided with TCZ. 

 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Rheumatologists' Comments

Just got detailed by pharma about actemra for GCA. Only problem is it is subq so because most patients with GCA are on Medicare it is not covered by part B which it would have been if they had gotten approval for IV actemra which also works for GCA. Since they will have to use part D it will cost them more money than many of them have. Genentech says we can fill out paperwork to apply for patient assistance if it is available and they meet income qualifications. Filling out more paperwork which may or may not get them the drug is exactly what I want to do! Sterling West,MD

More Like This

FDA Approves Mepolizumab for Churg-Strauss (EGPA)

The Food and Drug Administration (FDA) approved use of Nucala (mepolizumab) for use in treating adults with eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss vasculitis. This is first FDA-approved therapy specifically to treat EGPA. 

EGPA is rare with an stimated incidence of 0.11 to 2.66 cases per 1 million per year and an overall prevalence of 10.7 to 14 per 1,000,000 adults.

Do JAK Inhibitors Increase the Risk of Venous Thromboembolic Events?

Drug Safety has published a systematic review of the FDA’s Adverse Event Reporting System (FAERS) and finds numerous reports of thromboembolic adverse events (AEs) associated with two currently marketed Janus kinase (JAK) inhibitors, tofacitinib (Xeljanz) and ruxolitinib (Jakafi). (Citation source: https://buff.ly/2zXyY2X)

BMS Featured Presentations from ACR 2017

Bristol-Myers Squibb Company confirmed that 34 abstracts related to ORENCIA® (abatacept) and the Company’s immunoscience pipeline will be presented at the 2017 American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting, November 3-8, 2017, in San Diego.

Biosimilars Projected to Yield $54 Billion in Savings

A primary projected advantage to biosimilar drugs development has been cost savings. A new study from the RAND Corporation suggests biosimilars could cut health care spending in the United States by $54 billion over the next decade. This number is nearly 20 percent greater than a similar study conducted three years ago by the same researchers. 

Patterns of Biologic Use During Autoimmune Pregnancy

While it is highly desirable to avoid medications during conception and pregnancy, statistics show that >90% of women take at least one drug during pregnancy and nearly half will take 3 or more medications during pregnancy.