Tocilizumab Plus a Short Prednisone Taper for GCA

Inclusion Criteria

• Ability and willingness to provide written informed consent and to comply with the study protocol
• Diagnosis of GCA classified per the following criteria:
• Age 50 years or older

AND at least one of the following:

• Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
• Symptoms of polymyalgia rheumatica (PMR), defined as shoulder and / or hip girdle pain associated with inflammatory morning stiffness

AND at least one of the following:

• Cranial artery biopsy revealing features of GCA (e.g., mononuclear cell infiltration or granulomatous inflammation).
• Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as Image result for magnetic resonance angiogram (MRA), Computed tomography angiography (CTA) , or Image result for positron emission tomography (PET) and computed tomography (CT) (PET-CT)
• Ultrasound demonstration of features of GCA in a cranial artery.
• New-onset or relapsing/refractory active disease defined as follows:
• New onset: diagnosis of GCA within 6 weeks of baseline visit
• Relapsing/refractory: diagnosis of GCA > 6 weeks before baseline visit

AND

• Active GCA within 6 weeks of baseline visit defined as the presence of clinical signs and symptoms [cranial or PMR] and erythrocyte sedimentation rate (ESR) ≥ 30 mm/hour or C-reactive protein (CRP) ≥ 10 mg/L)

Exclusion Criteria

• General exclusion criteria
• Major surgery within 8 weeks prior to screening or planned major surgery within 12 months after randomization
• Transplanted organs (except corneal transplant performed more than 3 months prior to screening)
• Major ischemic event, unrelated to GCA, within 12 weeks of screening
• Exclusions related to prior or concomitant therapy*
• Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
• Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to Campath (alemtuzumab), anti-CD4 (cluster of differentiation 4), anti-CD5, anti-CD3, anti-CD19, and anti-CD20
• Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation
• Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to baseline
• Treatment with cyclosporine A, azathioprine, cyclophosphamide or Mycophenolate mofetil (MMF) within 4 weeks of baseline. Patients on methotrexate at screening will require discontinuation of this agent prior to baseline visit.
• Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of baseline
• Patients requiring systemic glucocorticoid therapy for conditions other than GCA, which, in the opinion of the investigator, would interfere with adherence to the fixed glucocorticoid taper regimen and/or to assessment of efficacy in response to TCZ
• Inability, in the opinion of the investigator, to withdraw GC treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency
• Patients treated with TCZ before will be permitted to participate in the trial if they demonstrated treatment efficacy and they did not discontinue TCZ because of an adverse effect.
• Exclusions related to general safety
• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
• Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, or gastrointestinal (GI) disease
• Current liver disease, as determined by the investigator

*