Safety and effectiveness of combination versus monotherapy with immune checkpoint inhibitors in patients with preexisting autoimmune diseases

References

• Dubin K, Callahan MK, Ren B, Khanin R, Viale A, Ling L, No D, Gobourne A, Littmann E, Huttenhower C, et al. Intestinal microbiome analyses identify melanoma patients at risk for checkpoint-blockade-induced colitis. Nat Commun. 2016;7(1):10391. doi:10.1038/ncomms10391.
   PubMed Web of Science ®Google Scholar
• Franks AL, Slansky JE. Multiple associations between a broad spectrum of autoimmune diseases, chronic inflammatory diseases and cancer. Anticancer Res. 2012;32:1119–11.
   PubMed Web of Science ®Google Scholar
• Leonardi GC, Gainor JF, Altan M, Kravets S, Dahlberg SE, Gedmintas L, Azimi R, Rizvi H, Riess JW, Hellmann MD, et al. Safety of programmed death–1 pathway inhibitors among patients with non–small-Cell lung cancer and preexisting autoimmune disorders. J Clin Oncol. 2018;36(19):1905–1912. doi:10.1200/Jco.2017.77.0305.
   PubMed Web of Science ®Google Scholar
• Abdel-Wahab N, Safa H, Abudayyeh A, Johnson DH, Trinh VA, Zobniw CM, Lin H, Wong MK, Abdelrahim M, Gaber AO, et al. Checkpoint inhibitor therapy for cancer in solid organ transplantation recipients: an institutional experience and a systematic review of the literature. J Immunother Cancer. 2019;7(1):106. doi:10.1186/s40425-019-0585-1. [ published Online First: 2019/04/18].
   PubMed Web of Science ®Google Scholar
• Peng M, Li X, Lei G, Weng YM, Hu MX, Song QB. The efficacy and safety of immune checkpoint inhibitor combination therapy in lung cancer: a systematic review and meta-analysis. Onco Targets Ther. 2018;11:7369–7383. doi:10.2147/OTT.S177318. [ published Online First: 2018/11/15].
   PubMed Web of Science ®Google Scholar
• Horvat TZ, Adel NG, Dang TO, Momtaz P, Postow MA, Callahan MK, Carvajal RD, Dickson MA, D’Angelo SP, Woo KM, et al. Immune-related adverse events, need for systemic immunosuppression, and effects on survival and time to treatment failure in patients with melanoma treated with ipilimumab at memorial sloan Kettering cancer center. J Clin Oncol. 2015;33(28):3193–3198. doi:10.1200/JCO.2015.60.8448. [ published Online First: 2015/08/19].
   PubMed Web of Science ®Google Scholar
• Coens C, Suciu S, Chiarion-Sileni V, Grob J-J, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, et al. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol. 2017;18(3):393–403. doi:10.1016/S1470-2045(17)30015-3.
   PubMed Web of Science ®Google Scholar
• Cappelli LC, Gutierrez AK, Bingham CO 3rd, Shah AA. Rheumatic and Musculoskeletal immune-related adverse events due to immune checkpoint inhibitors: a systematic review of the literature. Arthritis Care Res (Hoboken). 2017;69(11):1751–1763. doi:10.1002/acr.23177. [ published Online First: 2016/12/21].
   PubMed Web of Science ®Google Scholar
• Sandigursky S, Mor A. Immune-related adverse events in cancer patients treated with immune checkpoint inhibitors. Curr Rheumatol Rep. 2018;20(10):65. doi:10.1007/s11926-018-0770-0. published Online First: 2018/09/08.
   PubMed Web of Science ®Google Scholar
• El Osta B, Hu F, Sadek R, Chintalapally R, Tang S-C. Not all immune-checkpoint inhibitors are created equal: meta-analysis and systematic review of immune-related adverse events in cancer trials. Crit Rev Oncol Hematol. 2017;119:1–12. doi:10.1016/j.critrevonc.2017.09.002. [ published Online First: 2017/10/27].
   PubMed Web of Science ®Google Scholar
• Xing P, Zhang F, Wang G, Xu Y, Li C, Wang S, Guo Y, Cai S, Wang Y, Li J, et al. Incidence rates of immune-related adverse events and their correlation with response in advanced solid tumours treated with NIVO or NIVO+IPI: a systematic review and meta-analysis. J Immunother Cancer. 2019;7(1):341. doi:10.1186/s40425-019-0779-6.
   PubMed Web of Science ®Google Scholar
• Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WEE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, et al. Nivolumab versus docetaxel in advanced squamous-Cell non–small-Cell lung cancer. N Engl J Med. 2015;373(2):123–135. doi:10.1056/NEJMoa1504627.
   PubMed Web of Science ®Google Scholar
• Hodi FS, O’Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711–723. doi:10.1056/NEJMoa1003466.
   PubMed Web of Science ®Google Scholar
• Giat E, Ehrenfeld M, Shoenfeld Y. Cancer and autoimmune diseases. Autoimmun Rev. 2017;16(10):1049–1057. doi:10.1016/j.autrev.2017.07.022. [ published Online First: 2017/08/06].
   PubMed Web of Science ®Google Scholar
• Hemminki K, Liu X, Ji J, Sundquist J, Sundquist K. Autoimmune disease and subsequent digestive tract cancer by histology. Ann Oncol. 2012;23(4):927–933. doi:10.1093/annonc/mdr333.
   PubMed Web of Science ®Google Scholar
• Abdel-Wahab N, Abudayyeh A, Lei X. Checkpoint inhibitor therapy in solid organ and allogeneic stem Cell transplantation: data mining of the Truven Health marketscan research database. J Immunother Cancer (Suppl). 2018;6(1):115.
   PubMedGoogle Scholar
• Menzies AM, Johnson DB, Ramanujam S, Atkinson VG, Wong ANM, Park JJ, McQuade JL, Shoushtari AN, Tsai KK, Eroglu Z, et al. Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab. Ann Oncol. 2017;28(2):368–376. doi:10.1093/annonc/mdw443.
   PubMed Web of Science ®Google Scholar
• Hong D, Infante J, Janku F, Jones S, Nguyen LM, Burris HA, Naing A, Bauer TM, Piha-Paul S, Johnson FM, et al. Phase I study of LY2606368, a checkpoint kinase 1 inhibitor, in patients with advanced cancer. J Clin Oncol. 2016;34(15):1764–1771. doi:10.1200/JCO.2015.64.5788.
   PubMed Web of Science ®Google Scholar
• Wu C, Zhong L, Wu Q, Lin S, Xie X. The safety and efficacy of immune-checkpoint inhibitors in patients with cancer and pre-existing autoimmune diseases. Immunotherapy. 2021;13(6):527–539. doi:10.2217/imt-2020-0230.
   PubMed Web of Science ®Google Scholar
• Tang H, Zhou J, Bai C. The efficacy and safety of immune checkpoint inhibitors in patients with cancer and preexisting autoimmune disease. Front Oncol. 2021;11(53):625872. doi:10.3389/fonc.2021.625872.
   PubMedGoogle Scholar
• Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob J-J, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, et al. Overall survival with combined Nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377(14):1345–1356. doi:10.1056/NEJMoa1709684. [ published Online First: 2017/09/12].
   PubMed Web of Science ®Google Scholar
• Institute NIoHNNC. Common Terminology Criteria for Adverse Events (CTCAE). NIH; 2018.
   Google Scholar
• Wang DY, Salem JE, Cohen JV, Chandra S, Menzer C, Ye F, Zhao S, Das S, Beckermann KE, Ha L, et al. Fatal toxic effects associated with immune checkpoint inhibitors: a systematic review and meta-analysis. JAMA Oncol. 2018;4(12):1721–1728. doi:10.1001/jamaoncol.2018.3923. [ published Online First: 2018/09/23].
   PubMed Web of Science ®Google Scholar
• Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, et al. Combined Nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373(1):23–34. doi:10.1056/NEJMoa1504030. [ published Online First: 2015/06/02].
   PubMed Web of Science ®Google Scholar
• Brown LJ, Weppler A, Bhave P, Allayous C, Patrinely Jr JR, Ott P, Sandhu S, Haydon A, Lebbe C, Johnson DB, et al. Combination anti-PD1 and ipilimumab therapy in patients with advanced melanoma and pre-existing autoimmune disorders. J Immunother Cancer. 2021;9(5):e002121. doi:10.1136/jitc-2020-002121. published Online First: 2021/05/09.
   PubMed Web of Science ®Google Scholar
• van der Kooij MK, Suijkerbuijk KPM, Aarts MJB, van der Kooij MK, van den Berkmortel FWPJ, Blank CU, Boers-Sonderen MJ, van Breeschoten J, van den Eertwegh AJM, de Groot JWB, et al. Safety and efficacy of checkpoint inhibition in patients with melanoma and preexisting autoimmune disease: a cohort study. Ann Intern Med. 2021;174(5):641–648. doi:10.7326/M20-3419. [ published Online First: 2021/02/16].
   PubMed Web of Science ®Google Scholar
• Bruera S, Suarez-Almazor ME. The effects of glucocorticoids and immunosuppressants on cancer outcomes in checkpoint inhibitor therapy. Front Oncol. 2022;12:928390. doi:10.3389/fonc.2022.928390. [ published Online First: 2022/09/10].
   PubMedGoogle Scholar
• Postow MA, Sidlow R, Hellmann MD, Longo DL. Immune-related adverse events associated with immune checkpoint blockade. N Engl J Med. 2018;378(2):158–168. doi:10.1056/NEJMra1703481. [ published Online First: 2018/01/11].
   PubMed Web of Science ®Google Scholar
• Haratani K, Hayashi H, Chiba Y, Kudo K, Yonesaka K, Kato R, Kaneda H, Hasegawa Y, Tanaka K, Takeda M, et al. Association of immune-related adverse events with Nivolumab efficacy in non–small-Cell lung cancer. JAMA Oncol. 2018;4(3):374–378. doi:10.1001/jamaoncol.2017.2925. [ published Online First: 2017/10/05].
   PubMed Web of Science ®Google Scholar
• Arbour KC, Mezquita L, Long N, Rizvi H, Auclin E, Ni A, Martinez Bernal G, Chaft JE, Ferrara R, Lai WCV, et al. Deleterious effect of baseline steroids on efficacy of PD-(L)1 blockade in patients with NSCLC. J Clin Oncol. 2018;36(15):9003–9003. doi:10.1200/JCO.2018.36.15_suppl.9003.
   Web of Science ®Google Scholar
• Maslov DV, Tawagi K, Kc M, Simenson V, Yuan H, Parent C, Bamnolker A, Goel R, Blake Z, Matrana MR, et al. Timing of steroid initiation and response rates to immune checkpoint inhibitors in metastatic cancer. J Immunother Cancer. 2021;9(7):e002261. doi:10.1136/jitc-2020-002261.
   PubMed Web of Science ®Google Scholar
• Faje AT, Lawrence D, Flaherty K, Freedman C, Fadden R, Rubin K, Cohen J, Sullivan RJ. High-dose glucocorticoids for the treatment of ipilimumab-induced hypophysitis is associated with reduced survival in patients with melanoma. Cancer. 2018;124(18):3706–3714. doi:10.1002/cncr.31629. [ published Online First: 2018/07/06].
   PubMed Web of Science ®Google Scholar
• Petrelli F, Signorelli D, Ghidini M, Ghidini A, Pizzutilo EG, Ruggieri L, Cabiddu M, Borgonovo K, Dognini G, Brighenti M, et al. Association of steroids use with survival in patients treated with immune checkpoint inhibitors: a systematic review and meta-analysis. Cancers. 2020;12(3):546. doi:10.3390/cancers12030546.
   PubMed Web of Science ®Google Scholar
• Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim S-W, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, et al. Nivolumab plus ipilimumab in advanced non–small-Cell lung cancer. N Engl J Med. 2019;381(21):2020–2031. doi:10.1056/NEJMoa1910231. [ published Online First: 2019/09/29].
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, et al. Nivolumab versus everolimus in advanced renal-Cell carcinoma. N Engl J Med. 2015;373(19):1803–1813. doi:10.1056/NEJMoa1510665. [ published Online First: 2015/09/26].
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthélémy P, Porta C, George S, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-Cell carcinoma. N Engl J Med. 2018;378(14):1277–1290. doi:10.1056/NEJMoa1712126. [ published Online First: 2018/03/22].
   PubMed Web of Science ®Google Scholar
• Mathias K, Rouhani S, Olson D, Bass AR, Gajewski TF, Reid P. Association between rheumatic autoantibodies and immune-related adverse events. Oncologist. 2023;28(5):440–448. doi:10.1093/oncolo/oyac252. [ published Online First: 2023/01/04].
   PubMed Web of Science ®Google Scholar
• Ghosh N, Chan KK, Jivanelli B, Bass AR. Autoantibodies in patients with immune-related adverse events from checkpoint inhibitors: a systematic literature review. J Clin Rheumatol. 2021;28(2):e498–e505. doi:10.1097/rhu.0000000000001777. [ published Online First: 2021/08/10].
   Web of Science ®Google Scholar
• de Moel EC, Rozeman EA, Kapiteijn EH, Verdegaal EME, Grummels A, Bakker JA, Huizinga TWJ, Haanen JB, Toes REM, van der Woude D. Autoantibody development under treatment with immune-checkpoint inhibitors. Cancer Immunol Res. 2019;7(1):6–11. doi:10.1158/2326-6066.CIR-18-0245. [ published Online First: 2018/11/15].
   PubMed Web of Science ®Google Scholar
• Toi Y, Sugawara S, Sugisaka J, Ono H, Kawashima Y, Aiba T, Kawana S, Saito R, Aso M, Tsurumi K, et al. Profiling preexisting antibodies in patients treated with anti–PD-1 therapy for advanced non–small Cell lung cancer. JAMA Oncol. 2019;5(3):376–383. doi:10.1001/jamaoncol.2018.5860. [ published Online First: 2018/12/28].
   PubMed Web of Science ®Google Scholar
• Tahir SA, Gao J, Miura Y, Blando J, Tidwell RSS, Zhao H, Subudhi SK, Tawbi H, Keung E, Wargo J, et al. Autoimmune antibodies correlate with immune checkpoint therapy-induced toxicities. Proc Natl Acad Sci U S A. 2019;116(44):22246–22251. doi:10.1073/pnas.1908079116. [ published Online First: 2019/10/16].
   PubMed Web of Science ®Google Scholar
• Dimitriou F, Hogan S, Menzies AM, Dummer R, Long GV. Interleukin-6 blockade for prophylaxis and management of immune-related adverse events in cancer immunotherapy. Eur J Cancer. 2021;157:214–224. doi:10.1016/j.ejca.2021.08.031.
   PubMed Web of Science ®Google Scholar
• Hailemichael Y, Johnson DH, Abdel-Wahab N, Foo WC, Bentebibel S-E, Daher M, Haymaker C, Wani K, Saberian C, Ogata D, et al. Interleukin-6 blockade abrogates immunotherapy toxicity and promotes tumor immunity. Cancer Cell. 2022;40(5):509–523.e6. doi:10.1016/j.ccell.2022.04.004. [ published Online First: 2022/05/11].
   PubMed Web of Science ®Google Scholar
• Fa’ak F, Buni M, Falohun A, Lu H, Song J, Johnson DH, Zobniw CM, Trinh VA, Awiwi MO, Tahon NH, et al. Selective immune suppression using interleukin-6 receptor inhibitors for management of immune-related adverse events. J Immunother Cancer. 2023;11(6):e006814. doi:10.1136/jitc-2023-006814.
   PubMed Web of Science ®Google Scholar
• Mehmi I, Hamid O, Hodi FS, Vassalo M, Malatyali S, Krishnarajapet S, O’Donnell N, Castrence A, Lim E, Gormley J, et al. Ipilimumab, nivolumab and tocilizumab as first-line therapy for advanced melanoma. J Clin Oncol. 2021;39(15_suppl):PSTPS9589–TPS9589. doi:10.1200/JCO.2021.39.15_suppl.TPS9589.
   Google Scholar
• Stroud CR, Hegde A, Cherry C, Naqash AR, Sharma N, Addepalli S, Cherukuri S, Parent T, Hardin J, Walker P, et al. Tocilizumab for the management of immune mediated adverse events secondary to PD-1 blockade. J Oncol Pharm Pract. 2019;25(3):551–557. doi:10.1177/1078155217745144. [ published Online First: 2017/12/07].
   PubMed Web of Science ®Google Scholar