– Adult patients aged between 18 and 64
– Systemic sclerosis diagnosed within the last 5 years
– Moderate to severe skin involvement
– No response to three or more previous treatments for the condition
– Severe cardiac or pulmonary involvement
– Pulmonary arterial hypertension
– Have been diagnosed with Behçet’s disease, dermatomyositis, immune thrombocytopenic purpura, autoimmune necrotising myopathy or bullous pemphigoid
– Have a disease that is refractory to or intolerant of standard maintenance treatments
– Have been vaccinated against meningococcal serogroups A, B, C, W and Y, pneumococcus, and Haemophilus influenzae type B.
– Overlapping connective tissue disorders (except dermatomyositis/Gougerot-Sjögren or autoimmune necrotising myopathy/Gougerot-Sjögren)
– Active infection
– Moderate to severe skin involvement
– Negative anti-RNA polymerase-3 autoantibodies + first non-Raynaud’s symptom < 5 years OR positive anti-RNA polymerase-3 autoantibodies + first non-Raynaud’s symptom < 2 years
– Severe digital vasculopathy within the last 3 months
– Pulmonary arterial hypertension
– Severe pulmonary involvement
Systemic lupus erythematosus
– Have moderate to severe active disease
– Must not have responded to (or tolerated) three or more treatments for the condition
Idiopathic inflammatory myopathy
– Must have active severe disease
– Must not have responded to (or tolerated) two or more treatments for the condition
Rheumatoid arthritis
– Swollen joints ≥ 6; painful joints ≥ 6
– Have active disease
– Have not responded to (or have not tolerated) two or more biologic or targeted therapies for the disease
– Active lupus nephritis
– Inclusion body myositis
– Active or past lupus-related neurological involvement
– Severe pulmonary involvement
– Use of certain immunosuppressive treatments
– Have been diagnosed with systemic sclerosis, inflammatory myopathy, or Gougerot-Sjögren syndrome.
– Have active disease (e.g. moderate to severe skin sclerosis for cutaneous sclerosis; or painful and swollen joints for rheumatoid arthritis)
– Severe cardiac or pulmonary involvement
– Having previously been treated with haematopoietic stem cell autologous transplantation or CAR-T cells.
– Adult patients aged over 18 years with systemic sclerosis meeting the 2013 ACR/EULAR criteria
– Patients with at least one active digital ischaemic ulcer, located beyond the proximal interphalangeal joint (but not situated on subcutaneous calcifications or bony prominences) and refractory after 10 ± 2 weeks of standard treatment in accordance with the recommendations of the National Scleroderma Care Programme (PNDS).
Patient-related:
– Patients who have been taking statins, vasodilators, calcium channel blockers, ACE inhibitors, nitroglycerine, α-adrenergic blockers, adrenergic or angiotensin II receptor antagonists, N-acetylcysteine or low-molecular-weight heparin for less than 3 months, or whose condition has been unstable for the past month;
– Systemic antibiotics (oral and intravenous) administered to treat infected digital ulcers within the past 4 weeks;
– Local injection of botulinum toxin into a finger within the past 4 weeks;
– Surgical sympathectomy of the upper limbs or wound debridement within the last month;
– Patients who have undergone an autologous haematopoietic stem cell transplant (HSCT) within the 12 months prior to inclusion;
– Patients for whom autologous HSCT is indicated as an escalation therapy;
– History of cancer within the last five years.
Relating to each digital ulcer:
– Digital ulcer caused by conditions other than scleroderma, non-ischaemic, with osteomyelitis or a clinically uncontrolled infection, or an infected ulcer requiring systemic antibiotic treatment or urgent surgical intervention.
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