Giantcell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. Phase 3 trial confirms superiority of tocilizumab to. Tocilizumab, a humanized monoclonal antibody targeting the interleukin6 receptor, has been used with great efficacy and safety in rheumatoid arthritis and systemiconset juvenile idiopathic arthritis. Tocilizumab is a monoclonal antibody which binds to the il6 receptor alpha and blocks the cytokine il6 from binding to its receptor. A retrospective multicenter study that included 34 patients receiving tcz for gca. Gca therapy, which could include initiationtermination of openlabel tcz. A study of the safety and effectiveness of roactemra actemra tocilizumab for patients with giant cell arteritis rochester, mn. The effect of the interleukin6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giant cell arteritis. The purpose of this study is to evaluate the effectiveness and safety of roactemra actemra tocilizumab for the treatment of patients who have giant cell arteritis. Subgroups people with relapsing or refractory giant cell arteritis have the highest unmet need 3. Giant cell arteritis is a type of vasculitis that causes arteries to become narrow or irregular, disrupting.
Glucocorticoid gc treatment controls symptoms and reduces the risk of vascular complications such as vessel occlusion with blindness or rupture with fatal bleeding. Tocilizumab is not approved for intravenous use in patients with giant cell arteritis. The phase ii trial by villiger et al and the giacta trial both showed that tocilizumab greatly increased the rate of sustained remission in giant cell arteritis. Food and drug administration fda has approved actemra tocilizumab subcutaneous injection for the treatment of gca, a chronic and severe autoimmune. Giantcell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is. Giacta trial is a randomized, phase iii controlled clinical trial evaluating the efficacy of tocilizumab tcz in giant cell arteritis gca 2. Giant cell arteritis gca is a systemic largevessel vasculitis found almost. These findings are consistent with the hypothesis that interleukin6 plays an important part in the pathogenesis of giant cell arteritis, and that inhibition of interleukin6 might induce and maintain remission of the disease. A phase iii, multicenter, randomized, doubleblind placebo. See full safety and boxed warnings for more information. Risk of relapse after discontinuation of tocilizumab therapy.
Pdf trial of tocilizumab in giantcell arteritis researchgate. Giant cell arteritis is a disease of elderly people, with the peak onset at 70 to 80 years of age. We will include trials that enrolled patients at least 50 years of age meeting american college of rheumatology 1990 guidelines for gca and. Tocilizumab actemra for giant cell arteritis the medical. Tocilizumab for treating giant cell arteritis ta518. Weekly actemra improves healthrelated quality of life. Patients who never had remission were considered to have had a flare at week 0 data were censored tick marks. Roche initiates phase iii clinical trial of actemra. Tocilizumab for giant cell arteritisa new giant step in. Trial of tocilizumab in giantcell arteritis patients received subcutaneous tocilizumab at a dose of 162 mg weekly or every other week, combined with a 26week prednisone taper, or placebo. Giant cell arteritis gca, temporal arteritis is an inflam matory disease of medium and largesized arteries that affects individuals older than 50 years of age 1. In this 1year trial, we randomly assigned 251 patients, in a 2.
Jul 27, 2017 trial of tocilizumab in giantcell arteritis patients received subcutaneous tocilizumab at a dose of 162 mg weekly or every other week, combined with a 26week prednisone taper, or placebo combined with a prednisone taper over a period of either 26 weeks or 52 weeks. Longterm outcome of tocilizumab for patients with giant cell arteritis. Tocilizumab for treating giant cell arteritis 1 recommendations 1. Healthrelated quality of life in patients with giant cell arteritis treated. We are committed to sharing findings related to covid19 as quickly and safely as possible.
Tocilizumab for induction and maintenance of remission in. Stone jh, tuckwell k, dimonaco s, klearman m, aringer m, blockmans d, brouwer e, cid mc, dasgupta b, rech j, salvarani c, schulzekoops h, schett g, spiera r, unizony sh, collinson n. Giant cell arteritis clinical trials mayo clinic research. These findings were extended by the phase 3 giacta trial giant cell arteritis actemra that enrolled 251 patients with newonset, relapsing, or refractory gca. Learn about actemra tocilizumab, an fdaapproved option for the treatment of giant cell arteritis gca. Tocilizumab, also known as atlizumab, is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis ra and systemic juvenile idiopathic arthritis, a severe form of arthritis in. Longterm outcome of tocilizumab for patients with giant. Design of the tocilizumab in giant cell arteritis trial the harvard community has made this article openly available. Giant cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. Nearly half of patients in clinical remission after receiving 1 year of weekly tocilizumab for giant cell arteritis maintained their treatmentfree remission for an additional 2 years, noted john. Results from part 2 of a randomized controlled phase 3 trial abstract.
Design of the tocilizumab in giant cell arteritis trial harvards dash. Giant cell arteritis gca treatment hcp actemra tocilizumab. Trial of tocilizumab in giantcell arteritis american. Giant cell arteritis gca the overall safety profile observed in the actemra treatment groups was generally consistent with the known safety profile of actemra. Efficacy and safety of tocilizumab in patients with. Table 3 design of the tocilizumab in giant cell arteritis trial. Is tocilizumab actemra effective in the treatment of giant.
In patients with giant cell arteritis, a regimen of tocilizumab given 162 mg weekly plus a 26week prednisone taper demonstrated significant improvements in healthrelated quality of life and. Tocilizumab for patients with giant cell arteritis the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Giant cell arteritis gca treatment actemra tocilizumab. Glucocorticoid dosages and acutephase reactant levels at giant cell arteritis flare in a randomized trial of tocilizumab. An efficacy and safety study of tocilizumab roactemra actemra in participants with giant cell arteritis gca. Roche initiates phase iii clinical trial of actemra roactemra in hospitalised patients with severe covid19 pneumonia. Tocilizumab increased sustained glucocorticoidfree.
Fda approves tocilizumab actemra for giant cell arteritis. The giacta trial is a multicenter, randomized, doubleblind, and placebocontrolled study designed to test the ability of tocilizumab tcz, an interleukin il6 receptor antagonist, to maintain disease remission in patients with giant cell arteritis. Actemra is a prescription medicine called an interleukin6 il6 receptor antagonist. The giacta trial was a 52week doubleblind randomized controlled trial rct. Tocilizumab for patients with giant cell arteritis study. It is the first drug to be approved in the us for this indication. Results from part 2 of a randomized controlled phase 3 trial. There was an overall higher incidence of infections in gca patients relative to ra patients. Giant cell arteritis gca is the most common primary systemic vasculitis in north america, often involving cranial arteries, the thoracic aorta, and subclavian and axillary arteries. Original article from the new england journal of medicine trial of tocilizumab in giantcell arteritis. Design of the tocilizumab in giant cell arteritis trial hindawi. Tocilizumab for the treatment of giant cell arteritis a.
Fda approves roches actemraroactemra tocilizumab for. This trial of tocilizumab for the treatment of giantcell arteritis showed that the two regimens of tocilizumab weekly and of tocilizumab every other week, in combination with a prednisone taper. Approximately centers will enroll patients with active disease. Tcz was effective in all but 6 patients, who still had mild symptoms. Fda approves genentechs actemra for giant cell arteritis. A phase 3 study of tocilizumab in giant cell arteritis is needed to confirm these findings. A first randomized phase ii trial followed 19, and finally the. A phase 3 study of tocilizumab in giant cell arteritis. Giant cell arteritis gca is characterized by a destructive, granulomatous inflammation in the walls of medium and largesized arteries. This multicenter, randomized, doubleblind, placebocontrolled study will evaluate the efficacy and safety of roactemra actemra tocilizumab in patients with giant cell arteritis. Tocilizumab for giant cell arteritis to assess the effectiveness and safety of tocilizumab, given alone or with corticosteroids, compared with therapy without tocilizumab for treatment of gca. Background baseline characteristics of patients from giacta trial have been recently reported at the acr2016 conference 1.
Randomized placebocontrolled trial giantcell arteritis actemra giacta trial. Clinical trial results show that after having tocilizumab plus a tapering course of. Trial of tocilizumab in giantcell arteritis request pdf. Actemra effective in giant cell arteritis rheumnow. An efficacy and safety study of tocilizumab roactemra actemra in participants with giant cell arteritis gca the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
The effect of the interleukin6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giantcell arteritis. The giant cell arteritis actemra giacta trial was a phase iii double blinded clinical trial testing tocilizumab actemra for giant cell arteritis. In patients with giant cell arteritis gca, does tocilizumab increase the likelihood of sustained glucocorticoidfree remission. This new indication is largely based on the landmark giacta study presented at the annual acr meeting in november 2016. Adults with moderately to severely active rheumatoid arthritis ra after at least one other medicine called a disease modifying antirheumatic drug dmard has been used and did not work well. The treatment of giant cell arteritis in different clinical settings. Phase 3 trial confirms superiority of tocilizumab to steroids. Clinical study design of the tocilizumab in giant cell. Health related quality of life hrqol in patients from this trial is now. Stone j, bao m, han j, aringer m, blockmans d, brouwer e, cid m, dasgupta b, rech j, salvarani c, spiera r, unizony s.
We had previously published a multicenter study on the use of tcz in refractory gca in a clinical practice setting 3. Phase 3 trial confirms superiority of tocilizumab to steroid. Design of the tocilizumab in giant cell arteritis trial. Listing a study does not mean it has been evaluated by the u. May 07, 2016 seven 35% patients in the tocilizumab group and five 50% in the placebo group had serious adverse events. To report the efficacy and safety of tocilizumab tcz for giant cell arteritis gca. Jul 26, 2017 results of the trial are being published in the new england journal of medicine and were the basis for the food and drug administrations approval of tocilizumab to treat giant cell arteritis in may. Tocilizumab for induction and maintenance of remission in giant cell arteritis. Our findings show, for the first time in a trial setting, the efficacy of tocilizumab in the induction and maintenance of remission in patients with giant cell arteritis.
Tocilizumab brand name actemra belongs to a new class of medicines called biological disease modifying antirheumatic drugs biological dmards or bdmards. Longterm outcome of tocilizumab for patients with giant cell. I was approved as a patient for the clinical trials for actemra. Tocilizumab for treating giant cell arteritis nice. Actemra is indicated for the treatment of giant cell arteritis gca.
On may 22, genentech received fda approval for the use of subcutaneous sc tocilizumab tcz in patients with giant cell arteritis gca also known as temporal arteritis. The efficacy and safety of tocilizumab have been reported in patients with giant cell arteritis gca, another large vessel vasculitis, in two randomised controlled trials. A study of the safety and effectiveness of roactemra. A phase 3 clinical trial has confirmed that regular treatment with tocilizumab, an inhibitor of interleukin6, successfully reduced both symptoms of and the need for highdose steroid treatment for giant cell arteritis. The giant cell arteritis actemra giacta study, the largest randomised trial for this disease to date, involved 251 patients and describes the benefits of tocilizumab, an interleukin6 inhibitor. As interleukin6 has been shown to be a key cytokine in giant cell arteritis, the use of an inhibiting agent has been explored. Half of gca patients receiving tocilizumab remained in.
The fda has approved the interleukin6 il6 receptor antagonist tocilizumab actemra genentech for subcutaneous sc treatment of giant cell arteritis in adults. Actemra is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis ra who have had an inadequate response to one or more diseasemodifying antirheumatic drugs dmards. Tocilizumab actemra was approved by the fda in may 2017 for giant cell arteritis gca. Actemra is indicated for the treatment of giant cell arteritis. An efficacy and safety study of tocilizumab roactemra. The giacta trial is a multicenter, randomized, doubleblind, and placebocontrolled study designed to test the ability of tocilizumab tcz. The giacta trial is a multicenter, randomized, doubleblind, and placebocontrolled study designed to test the ability of tocilizumab tcz, an interleukin il6 receptor antagonist, to maintain disease remission in patients with giant cell arteritis gca. Time to first flare after clinical remission of giant cell arteritis in all patients. Patients will be randomized to receive either roactemra actemra. Tocilizumab for giant cell arteritisa new giant step in an. A phase 3 clinical trial has confirmed that regular treatment with tocilizumab, an inhibitor of interleukin6, successfully reduced both symptoms of and the need for highdose steroid treatment for giant cell arteritis, the most common form of bloodvessel inflammation. Actemra roactemra sc injection is also the first approved therapy for the treatment of giant cell arteritis gca in more than 40 countries, including the us and europe. One patient died and 3 patients had to stop tcz therapy because of severe adverse events. Exclusion criteria 1 diagnosis of gca 2 active disease within 6 weeks of baseline visit 3 willing to.