Monday, 26 Jun 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 ( 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. 


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

Supreme Court Decision Favors Earlier Biosimilar Adoption

On Monday June 11th, the US Supreme Court unanimously ruled that biosimilar manufacturers can bring their drugs to market faster by eliminating the provision that the biosimar manufacturer had to give the innovator company 180 days notice before launching the new biosimilar.

Upadacitinib Effective in Rheumatoid Arthritis

AbbVie released the preliminary results of a rheumatoid arthritis trial wherein its Jak inhibitor, upadacitinib, was tested against placebo, and shown to be superior in established RA patients who have failed prior DMARD therapy.

Biosimilar Reports – May 2017

Biosimilars continue to command a great deal of research, development and attention given the promise of significant cost savings and potentially wider use for those in need. Biosimilar Reports is an ongoing series dedicated to advances, discussions and developments in biosimilar agents intended for use by rheumatologists. 

Anti-IL-5 Success in Eosinophilic Granulomatosis with Polyangiitis

The NEJM reports success when using mepolizumab (anti-IL-5 monoclonal antibody) in a 52 week study of patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Tofacitinib Effective in Ulcerative Colitis

Tofacitinib is currently approved for use in rheumatoid arthritis, but is being studied in numerous other inflammatory conditons including spondylitis, psoriasis, and psoriatic arthritis, and has also been studied in patients with ulcerative colitis (UC).