Table 1.
Patient demographics and baseline characteristics
| Patient characteristics | N=92 |
| Mean age at ICI initiation (±SD) | 60.4±12.66 |
| Sex, n (%) | |
| Female | 34 (37) |
| Male | 58 (63) |
| Cancer type, n (%) | |
| Melanoma | 42 (46) |
| Renal cell carcinoma | 19 (21) |
| Bladder | 11 (12) |
| Non-small cell lung cancer | 7 (8) |
| Breast | 2 (2) |
| Prostate | 2 (2) |
| Squamous cell carcinoma of the head and neck | 2 (2) |
| Others* | 7 (8) |
| Immune checkpoint inhibitor type, n (%) | |
| Anti-PD-1 | 63 (69) |
| Anti-CTLA-4+anti-PD-1 | 24 (26) |
| Anti-PD-L1 | 3 (3) |
| Anti-CTLA-4 | 2 (2) |
| Cancer stage, n (%)† | |
| IV | 80 (87) |
| III | 10 (11) |
| Immune checkpoint inhibitor setting, n (%)‡ | |
| Metastatic | 80 (89) |
| Adjuvant | 10 (11) |
| History of pre-existing autoimmune disease, n (%) | 22 (24) |
| Rheumatoid arthritis§ | 14 (15) |
| Psoriasis with/without psoriatic arthritis | 4 (4) |
| Undifferentiated arthritis | 2 (2) |
| Polymyalgia rheumatica | 1 (1) |
| Sjogren’s syndrome | 1 (1) |
| Positive autoimmune markers, n (%) | |
| Positive at least one autoimmune marker | 48/78 (62) |
| IL-6 | 25/37 (68) |
| TNF-α | 13/28 (46) |
| IFN-γ | 8/29 (28) |
| ANA | 13/57 (23) |
| RF | 13/58 (22) |
| Anti-CCP | 8/55 (15) |
| Anti-SSA | 2/17 (12) |
| Anti-SSB | 2/42 (5) |
| HLA-B27 | 1/31 (3) |
| Types of irAEs treated with anti-IL-6R, n (%) | |
| Arthritis (new-onset or flare-ups of pre-existing arthritis) | 67 (73) |
| Rheumatoid arthritis-like | 46 (50) |
| Inflammatory polyarthritis | 11 (12) |
| Oligoarthritis of large joints | 5 (5) |
| Spondyloarthropathy-like (SPA-like) | 2 (2) |
| Psoriatic arthritis | 2 (2) |
| Polymyalgia rheumatica with peripheral synovitis | 1 (1) |
| Cholangitis/hepatitis | 6 (7) |
| Encephalitis | 5 (5) |
| Myositis/myasthenia gravis/myocarditis | 5 (5) |
| Myositis, myasthenia gravis and myocarditis | 2 (2) |
| Myositis and myasthenia gravis | 2 (2) |
| Myositis and myocarditis | 1 (1) |
| Polymyalgia rheumatica | 4 (4) |
| Pneumonitis | 1 (1) |
| Nephritis | 1 (1) |
| Colitis | 1 (1) |
| Systemic sclerosis | 1 (1) |
| CNS vasculitis | 1 (1) |
| First-line therapy for irAEs | |
| Corticosteroids | 81 (88) |
| Corticosteroid-sparing agents¶ | 33 (36) |
| Anti-IL-6R | 8 (9) |
| Pyridostigmine | 2 (2) |
| Plasmapheresis | 2 (2) |
| Intravenous immunoglobulin | 1 (1) |
| Anti-IL-6R type, dose/frequency, route, n (%) | |
| Sarilumab, 200 mg/2 weeks, subcutaneous | 4 (4) |
| Tocilizumab, 162 mg/2 weeks, subcutaneous | 31 (34) |
| Tocilizumab, 4 mg/kg/4 weeks, intravenous | 21 (23) |
| Tocilizumab, 8 mg/kg/4 weeks, intravenous | 10 (11) |
| Tocilizumab, 162 mg/1 week, subcutaneous | 9 (10) |
| Tocilizumab, 8 mg/kg once, intravenous | 8 (9) |
| Tocilizumab, 4 mg/kg once, intravenous | 7 (8) |
| Tocilizumab, 4 mg/kg/3 weeks, intravenous | 1 (1) |
| Tocilizumab, 162 mg once, subcutaneous | 1 (1) |
Numbers are rounded to the nearest whole number.
*Others: One patient each with acute myeloid leukemia, central nervous system lymphoma, cecal cancer, cervical cancer, Merkel cell, sarcoma, adrenal cancer.
†One patient had leukemia and one CNS lymphoma.
‡Information on ICI setting was not available for two patients.
§One patient had associated Sjogren’s Syndrome.
¶Corticosteroid-sparing agents used as a first-line treatment and varied widely according to the irAEs type including methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, apremilast, mycophenolate, tacrolimus, rituximab, vedolizumab, anakinra, infliximab, etanercept, and adalimumab.
ANA, antinuclear antibodies; anti-CCP, anti-citric citrullinated peptide; anti-SSA, anti-Sjogren’s Syndrome A; anti-SSB, anti-Sjogren’s Syndrome B; CNS, central nervous system; CTLA-4, cytotoxic T lymphocyte-associated protein 4; HLA-B27, human leukocyte antigen-B27; ICI, immune checkpoint inhibitor; IFN-γ, interferon gamma; IL-6, interleukin-6; IL-6RA, interleukin-6 receptor antagonist; irAE, immune-related adverse event; PD-1, programmed cell death protein 1; PD-L1, programmed cell death ligand 1; RF, rheumatoid factor; SC, subcutaneous; TNF-α, tumor necrosis factor-alpha.