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. 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. An efficacy and safety study of tocilizumab roactemra actemra in participants with giant cell arteritis gca. Randomized placebocontrolled trial giantcell arteritis actemra giacta trial. 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. This new indication is largely based on the landmark giacta study presented at the annual acr meeting in november 2016. Phase 3 trial confirms superiority of tocilizumab to steroid. 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. Tocilizumab is not approved for intravenous use in patients with giant cell arteritis. Tocilizumab increased sustained glucocorticoidfree. 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. 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. Giantcell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is.
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. Results from part 2 of a randomized controlled phase 3 trial abstract. Approximately centers will enroll patients with active disease. 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. The effect of the interleukin6 receptor alpha inhibitor tocilizumab on the rates of relapse during glucocorticoid tapering was studied in patients with giantcell arteritis. 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. This multicenter, randomized, doubleblind, placebocontrolled study will evaluate the efficacy and safety of roactemra actemra tocilizumab in patients with 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, a humanized monoclonal antibody targeting the interleukin6 receptor, has been used with great efficacy and safety in rheumatoid arthritis and systemiconset juvenile idiopathic arthritis.
Longterm outcome of tocilizumab for patients with giant cell. In this 1year trial, we randomly assigned 251 patients, in a 2. Risk of relapse after discontinuation of tocilizumab therapy. To report the efficacy and safety of tocilizumab tcz for giant cell arteritis gca. A study of the safety and effectiveness of roactemra. Tocilizumab for giant cell arteritisa new giant step in. Tocilizumab brand name actemra belongs to a new class of medicines called biological disease modifying antirheumatic drugs biological dmards or bdmards. Is tocilizumab actemra effective in the treatment of giant. Longterm outcome of tocilizumab for patients with giant cell arteritis. Gca therapy, which could include initiationtermination of openlabel tcz. Giant cell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects.
Giant cell arteritis gca the overall safety profile observed in the actemra treatment groups was generally consistent with the known safety profile of actemra. Giant cell arteritis gca treatment actemra tocilizumab. The fda has approved the interleukin6 il6 receptor antagonist tocilizumab actemra genentech for subcutaneous sc treatment of giant cell arteritis in adults. 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. Giant cell arteritis gca is characterized by a destructive, granulomatous inflammation in the walls of medium and largesized arteries. 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. Tocilizumab for induction and maintenance of remission in. Roche initiates phase iii clinical trial of actemra roactemra in hospitalised patients with severe covid19 pneumonia. Giant cell arteritis gca treatment hcp actemra tocilizumab. Giacta trial is a randomized, phase iii controlled clinical trial evaluating the efficacy of tocilizumab tcz in giant cell arteritis gca 2.
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. Tocilizumab for treating giant cell arteritis ta518. Stone j, bao m, han j, aringer m, blockmans d, brouwer e, cid m, dasgupta b, rech j, salvarani c, spiera r, unizony s. Tocilizumab for treating giant cell arteritis nice. I was approved as a patient for the clinical trials for actemra. The giacta trial was a 52week doubleblind randomized controlled trial rct. 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. It is the first drug to be approved in the us for this indication.
Half of gca patients receiving tocilizumab remained in. Tocilizumab for patients with giant cell arteritis the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Glucocorticoid gc treatment controls symptoms and reduces the risk of vascular complications such as vessel occlusion with blindness or rupture with fatal bleeding. Phase 3 trial confirms superiority of tocilizumab to steroids. Actemra effective in giant cell arteritis rheumnow.
Tocilizumab actemra for giant cell arteritis the medical. A retrospective multicenter study that included 34 patients receiving tcz for gca. May 07, 2016 seven 35% patients in the tocilizumab group and five 50% in the placebo group had serious adverse events. As interleukin6 has been shown to be a key cytokine in giant cell arteritis, the use of an inhibiting agent has been explored. Tocilizumab actemra was approved by the fda in may 2017 for giant cell arteritis gca.
Food and drug administration fda has approved actemra tocilizumab subcutaneous injection for the treatment of gca, a chronic and severe autoimmune. Trial of tocilizumab in giantcell arteritis american. Giantcell arteritis commonly relapses when glucocorticoids are tapered, and the prolonged use of glucocorticoids is associated with side effects. The treatment of giant cell arteritis in different clinical settings. Listing a study does not mean it has been evaluated by the u. Tocilizumab for giant cell arteritisa new giant step in an. Giant cell arteritis is a type of vasculitis that causes arteries to become narrow or irregular, disrupting. Longterm outcome of tocilizumab for patients with giant. 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.
Tocilizumab is a monoclonal antibody which binds to the il6 receptor alpha and blocks the cytokine il6 from binding to its receptor. We are committed to sharing findings related to covid19 as quickly and safely as possible. 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 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. A phase iii, multicenter, randomized, doubleblind placebo. Healthrelated quality of life in patients with giant cell arteritis treated. Pdf trial of tocilizumab in giantcell arteritis researchgate.
We had previously published a multicenter study on the use of tcz in refractory gca in a clinical practice setting 3. Giant cell arteritis clinical trials mayo clinic research. 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. The giacta trial is a multicenter, randomized, doubleblind, and placebocontrolled study designed to test the ability of tocilizumab tcz. Patients with giant cell arteritis gca treated with tocilizumab tcz. 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.
Clinical study design of the tocilizumab in giant cell. 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. Design of the tocilizumab in giant cell arteritis trial. A first randomized phase ii trial followed 19, and finally the. Tcz was effective in all but 6 patients, who still had mild symptoms. For the treatment of giant cell arteritis gca in adult patients. One patient died and 3 patients had to stop tcz therapy because of severe adverse events. Patients who never had remission were considered to have had a flare at week 0 data were censored tick marks.
Fda approves roches actemraroactemra tocilizumab for. Tocilizumab for treating giant cell arteritis 1 recommendations 1. Background baseline characteristics of patients from giacta trial have been recently reported at the acr2016 conference 1. Actemra is indicated for the treatment of giant cell arteritis gca. Glucocorticoid dosages and acutephase reactant levels at giant cell arteritis flare in a randomized trial of tocilizumab. Patients will be randomized to receive either roactemra actemra. Original article from the new england journal of medicine trial of tocilizumab in giantcell arteritis. Health related quality of life hrqol in patients from this trial is now. In patients with giant cell arteritis gca, does tocilizumab increase the likelihood of sustained glucocorticoidfree remission. A study of the safety and effectiveness of roactemra actemra tocilizumab for patients with giant cell arteritis rochester, mn. Tocilizumab for induction and maintenance of remission in giant cell arteritis. Design of the tocilizumab in giant cell arteritis trial hindawi. 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.
Fda approves tocilizumab actemra for giant cell arteritis. We will include trials that enrolled patients at least 50 years of age meeting american college of rheumatology 1990 guidelines for gca and. Tocilizumab for patients with giant cell arteritis study. An efficacy and safety study of tocilizumab roactemra. These findings were extended by the phase 3 giacta trial giant cell arteritis actemra that enrolled 251 patients with newonset, relapsing, or refractory gca. A phase 3 study of tocilizumab in giant cell arteritis. Tocilizumab for the treatment of giant cell arteritis a. Table 3 design of the tocilizumab in giant cell arteritis trial. Exclusion criteria 1 diagnosis of gca 2 active disease within 6 weeks of baseline visit 3 willing to. Time to first flare after clinical remission of giant cell arteritis in all patients. Design of the tocilizumab in giant cell arteritis trial harvards dash.
There was an overall higher incidence of infections in gca patients relative to ra patients. Subgroups people with relapsing or refractory giant cell arteritis have the highest unmet need 3. Trial of tocilizumab in giantcell arteritis request pdf. Actemra is indicated for the treatment of giant cell arteritis. 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. 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. Efficacy and safety of tocilizumab in patients with. Results from part 2 of a randomized controlled phase 3 trial. Clinical trial results show that after having tocilizumab plus a tapering course of.
Design of the tocilizumab in giant cell arteritis trial the harvard community has made this article openly available. Phase 3 trial confirms superiority of tocilizumab to. 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. 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. 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. Roche initiates phase iii clinical trial of actemra. 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. Weekly actemra improves healthrelated quality of life. At this time, there are only 2 randomized control trials to evaluate the efficacy and safety of tocilizumab use in giant cell arteritis. Giant cell arteritis gca is a systemic largevessel vasculitis found almost. Fda approves genentechs actemra for giant cell arteritis. The giant cell arteritis actemra giacta trial was a phase iii double blinded clinical trial testing tocilizumab actemra for giant cell arteritis.
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