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1. COVID-19 Vaccination and New Onset Glomerular Disease: Results from the IRocGN2 International Registry.

Author

Waldman, Meryl, Waldman, Meryl, Sinaii, Ninet, Lerma, Edgar, Kurien, Anila, Jhaveri, Kenar, Uppal, Nupur, Wanchoo, Rimda, Avasare, Rupali, Zuckerman, Jonathan, Liew, Adrian, Gallan, Alexander, El-Meanawy, Ashraf, Yagil, Yoram, Lebedev, Larissa, Baskaran, Krishoban, Vilayur, Eswari, Cohen, Adrienne, Weerasinghe, Nethmi, Petrakis, Ioannis, Stylianou, Kostas, Gakiopoulou, Hariklia, Hamilton, Alexander, Edney, Naomi, Millner, Rachel, Marinaki, Smaragdi, Rein, Joshua, Killen, John, Rodríguez Chagolla, Jose, Bassil, Claude, Lopez Del Valle, Ramon, Evans, Jordan, Zawaideh, Mona, Baxi, Pravir, Rodby, Roger, Vankalakunti, Mahesha, Mejia Vilet, Juan, Ramirez Andrade, Silvia, Homan, Mal, Vásquez Jiménez, Enzo, Perinpanayagam, Natasha, Velez, Juan, Mohamed, Muner, Mohammed, Khalid, Sekar, Arjun, Ollila, Laura, Aron, Abraham, Arellano Arteaga, Kevin, Islam, Mahmud, Berrio, Esperanza, Maoujoud, Omar, Morales, Rebecca, Seipp, Regan, Schulze, Carl, Yenchek, Robert, Vancea, Irina, Muneeb, Muhammad, Howard, Lilian, Caza, Tiffany, Urisman, Anatoly, Waldman, Meryl, Waldman, Meryl, Sinaii, Ninet, Lerma, Edgar, Kurien, Anila, Jhaveri, Kenar, Uppal, Nupur, Wanchoo, Rimda, Avasare, Rupali, Zuckerman, Jonathan, Liew, Adrian, Gallan, Alexander, El-Meanawy, Ashraf, Yagil, Yoram, Lebedev, Larissa, Baskaran, Krishoban, Vilayur, Eswari, Cohen, Adrienne, Weerasinghe, Nethmi, Petrakis, Ioannis, Stylianou, Kostas, Gakiopoulou, Hariklia, Hamilton, Alexander, Edney, Naomi, Millner, Rachel, Marinaki, Smaragdi, Rein, Joshua, Killen, John, Rodríguez Chagolla, Jose, Bassil, Claude, Lopez Del Valle, Ramon, Evans, Jordan, Zawaideh, Mona, Baxi, Pravir, Rodby, Roger, Vankalakunti, Mahesha, Mejia Vilet, Juan, Ramirez Andrade, Silvia, Homan, Mal, Vásquez Jiménez, Enzo, Perinpanayagam, Natasha, Velez, Juan, Mohamed, Muner, Mohammed, Khalid, Sekar, Arjun, Ollila, Laura, Aron, Abraham, Arellano Arteaga, Kevin, Islam, Mahmud, Berrio, Esperanza, Maoujoud, Omar, Morales, Rebecca, Seipp, Regan, Schulze, Carl, Yenchek, Robert, Vancea, Irina, Muneeb, Muhammad, Howard, Lilian, Caza, Tiffany, and Urisman, Anatoly

Abstract

KEY POINTS: IgAN and MCD are the most common de novo glomerular diseases reported after COVID-19 vaccination, particularly after mRNA vaccination. Membranous nephropathy, pauci-immune GN, and collapsing GN have also been attributed to COVID-19 vaccination, some with dual histologies. Recovery of kidney function and proteinuria remission is more likely in IgAN and MCD by 4–6 months compared with the other glomerular diseases. BACKGROUND: Patients with de novo glomerular disease (GD) with various renal histologies have been reported after vaccination against SARS-CoV-2. Causality has not been established, and the long-term outcomes are not known. To better characterize the GDs and clinical courses/outcomes, we created the International Registry of COVID-19 vaccination and Glomerulonephritis to study in aggregate patients with de novo GN suspected after COVID-19 vaccine exposure. METHODS: A REDCap survey was used for anonymized data collection. Detailed information on vaccination type and timing and GD histology were recorded in the registry. We collected serial information on laboratory values (before and after vaccination and during follow-up), treatments, and kidney-related outcomes. RESULTS: Ninety-eight patients with GD were entered into the registry over 11 months from 44 centers throughout the world. Median follow-up was 89 days after diagnosis. IgA nephropathy (IgAN) and minimal change disease (MCD) were the most common kidney diseases reported. Recovery of kidney function and remission of proteinuria were more likely in IgAN and MCD at 4–6 months than with pauci-immune GN/vasculitis and membranous nephropathy. CONCLUSIONS: The development of GD after vaccination against SARS-CoV-2 may be a very rare adverse event. Temporal association is present for IgAN and MCD, but causality is not firmly established. Kidney outcomes for IgAN and MCD are favorable. No changes in vaccination risk-benefit assessment are recommended based on these findings.

Published
2023

2. Shorter versus longer corticosteroid duration and recurrent immune checkpoint inhibitor-associated AKI.

Author

Gupta, Shruti, Gupta, Shruti, Garcia-Carro, Clara, Prosek, Jason, Glezerman, Ilya, Herrmann, Sandra, Garcia, Pablo, Abudayyeh, Ala, Lumlertgul, Nuttha, Malik, A, Loew, Sebastian, Beckerman, Pazit, Renaghan, Amanda, Carlos, Christopher, Rashidi, Arash, Mithani, Zain, Deshpande, Priya, Rangarajan, Sunil, Shah, Chintan, Seigneux, Sophie, Campedel, Luca, Kitchlu, Abhijat, Shin, Daniel, Coppock, Gaia, Ortiz-Melo, David, Sprangers, Ben, Aggarwal, Vikram, Benesova, Karolina, Wanchoo, Rimda, Murakami, Naoka, Cortazar, Frank, Reynolds, Kerry, Sise, Meghan, Soler, Maria, Leaf, David, Gupta, Shruti, Gupta, Shruti, Garcia-Carro, Clara, Prosek, Jason, Glezerman, Ilya, Herrmann, Sandra, Garcia, Pablo, Abudayyeh, Ala, Lumlertgul, Nuttha, Malik, A, Loew, Sebastian, Beckerman, Pazit, Renaghan, Amanda, Carlos, Christopher, Rashidi, Arash, Mithani, Zain, Deshpande, Priya, Rangarajan, Sunil, Shah, Chintan, Seigneux, Sophie, Campedel, Luca, Kitchlu, Abhijat, Shin, Daniel, Coppock, Gaia, Ortiz-Melo, David, Sprangers, Ben, Aggarwal, Vikram, Benesova, Karolina, Wanchoo, Rimda, Murakami, Naoka, Cortazar, Frank, Reynolds, Kerry, Sise, Meghan, Soler, Maria, and Leaf, David

Abstract

BACKGROUND: Corticosteroids are the mainstay of treatment for immune checkpoint inhibitor-associated acute kidney injury (ICPi-AKI), but the optimal duration of therapy has not been established. Prolonged use of corticosteroids can cause numerous adverse effects and may decrease progression-free survival among patients treated with ICPis. We sought to determine whether a shorter duration of corticosteroids was equally efficacious and safe as compared with a longer duration. METHODS: We used data from an international multicenter cohort study of patients diagnosed with ICPi-AKI from 29 centers across nine countries. We examined whether a shorter duration of corticosteroids (28 days or less) was associated with a higher rate of recurrent ICPi-AKI or death within 30 days following completion of corticosteroid treatment as compared with a longer duration (29-84 days). RESULTS: Of 165 patients treated with corticosteroids, 56 (34%) received a shorter duration of treatment and 109 (66%) received a longer duration. Patients in the shorter versus longer duration groups were similar with respect to baseline and ICPi-AKI characteristics. Five of 56 patients (8.9%) in the shorter duration group and 12 of 109 (11%) in the longer duration group developed recurrent ICPi-AKI or died (p=0.90). Nadir serum creatinine in the first 14, 28, and 90 days following completion of corticosteroid treatment was similar between groups (p=0.40, p=0.56, and p=0.89, respectively). CONCLUSION: A shorter duration of corticosteroids (28 days or less) may be safe for patients with ICPi-AKI. However, the findings may be susceptible to unmeasured confounding and further research from randomized clinical trials is needed.

Published
2022

3. Acute kidney injury in patients treated with immune checkpoint inhibitors.

Author

Gupta, Shruti, Gupta, Shruti, Short, Samuel AP, Sise, Meghan E, Prosek, Jason M, Madhavan, Sethu M, Soler, Maria Jose, Ostermann, Marlies, Herrmann, Sandra M, Abudayyeh, Ala, Anand, Shuchi, Glezerman, Ilya, Motwani, Shveta S, Murakami, Naoka, Wanchoo, Rimda, Ortiz-Melo, David I, Rashidi, Arash, Sprangers, Ben, Aggarwal, Vikram, Malik, A Bilal, Loew, Sebastian, Carlos, Christopher A, Chang, Wei-Ting, Beckerman, Pazit, Mithani, Zain, Shah, Chintan V, Renaghan, Amanda D, Seigneux, Sophie De, Campedel, Luca, Kitchlu, Abhijat, Shin, Daniel Sanghoon, Rangarajan, Sunil, Deshpande, Priya, Coppock, Gaia, Eijgelsheim, Mark, Seethapathy, Harish, Lee, Meghan D, Strohbehn, Ian A, Owen, Dwight H, Husain, Marium, Garcia-Carro, Clara, Bermejo, Sheila, Lumlertgul, Nuttha, Seylanova, Nina, Flanders, Lucy, Isik, Busra, Mamlouk, Omar, Lin, Jamie S, Garcia, Pablo, Kaghazchi, Aydin, Khanin, Yuriy, Kansal, Sheru K, Wauters, Els, Chandra, Sunandana, Schmidt-Ott, Kai M, Hsu, Raymond K, Tio, Maria C, Sarvode Mothi, Suraj, Singh, Harkarandeep, Schrag, Deborah, Jhaveri, Kenar D, Reynolds, Kerry L, Cortazar, Frank B, Leaf, David E, ICPi-AKI Consortium Investigators, Gupta, Shruti, Gupta, Shruti, Short, Samuel AP, Sise, Meghan E, Prosek, Jason M, Madhavan, Sethu M, Soler, Maria Jose, Ostermann, Marlies, Herrmann, Sandra M, Abudayyeh, Ala, Anand, Shuchi, Glezerman, Ilya, Motwani, Shveta S, Murakami, Naoka, Wanchoo, Rimda, Ortiz-Melo, David I, Rashidi, Arash, Sprangers, Ben, Aggarwal, Vikram, Malik, A Bilal, Loew, Sebastian, Carlos, Christopher A, Chang, Wei-Ting, Beckerman, Pazit, Mithani, Zain, Shah, Chintan V, Renaghan, Amanda D, Seigneux, Sophie De, Campedel, Luca, Kitchlu, Abhijat, Shin, Daniel Sanghoon, Rangarajan, Sunil, Deshpande, Priya, Coppock, Gaia, Eijgelsheim, Mark, Seethapathy, Harish, Lee, Meghan D, Strohbehn, Ian A, Owen, Dwight H, Husain, Marium, Garcia-Carro, Clara, Bermejo, Sheila, Lumlertgul, Nuttha, Seylanova, Nina, Flanders, Lucy, Isik, Busra, Mamlouk, Omar, Lin, Jamie S, Garcia, Pablo, Kaghazchi, Aydin, Khanin, Yuriy, Kansal, Sheru K, Wauters, Els, Chandra, Sunandana, Schmidt-Ott, Kai M, Hsu, Raymond K, Tio, Maria C, Sarvode Mothi, Suraj, Singh, Harkarandeep, Schrag, Deborah, Jhaveri, Kenar D, Reynolds, Kerry L, Cortazar, Frank B, Leaf, David E, and ICPi-AKI Consortium Investigators

Abstract

Immune checkpoint inhibitor-associated acute kidney injury (ICPi-AKI) has emerged as an important toxicity among patients with cancer. We collected data on 429 patients with ICPi-AKI and 429 control patients who received ICPis contemporaneously but who did not develop ICPi-AKI from 30 sites in 10 countries. Multivariable logistic regression was used to identify predictors of ICPi-AKI and its recovery. A multivariable Cox model was used to estimate the effect of ICPi rechallenge versus no rechallenge on survival following ICPi-AKI. ICPi-AKI occurred at a median of 16 weeks (IQR 8-32) following ICPi initiation. Lower baseline estimated glomerular filtration rate, proton pump inhibitor (PPI) use, and extrarenal immune-related adverse events (irAEs) were each associated with a higher risk of ICPi-AKI. Acute tubulointerstitial nephritis was the most common lesion on kidney biopsy (125/151 biopsied patients [82.7%]). Renal recovery occurred in 276 patients (64.3%) at a median of 7 weeks (IQR 3-10) following ICPi-AKI. Treatment with corticosteroids within 14 days following ICPi-AKI diagnosis was associated with higher odds of renal recovery (adjusted OR 2.64; 95% CI 1.58 to 4.41). Among patients treated with corticosteroids, early initiation of corticosteroids (within 3 days of ICPi-AKI) was associated with a higher odds of renal recovery compared with later initiation (more than 3 days following ICPi-AKI) (adjusted OR 2.09; 95% CI 1.16 to 3.79). Of 121 patients rechallenged, 20 (16.5%) developed recurrent ICPi-AKI. There was no difference in survival among patients rechallenged versus those not rechallenged following ICPi-AKI. Patients who developed ICPi-AKI were more likely to have impaired renal function at baseline, use a PPI, and have extrarenal irAEs. Two-thirds of patients had renal recovery following ICPi-AKI. Treatment with corticosteroids was associated with improved renal recovery.

Published
2021

4. Acute kidney injury in patients treated with immune checkpoint inhibitors.

Author

Gupta, Shruti, Gupta, Shruti, Short, Samuel AP, Sise, Meghan E, Prosek, Jason M, Madhavan, Sethu M, Soler, Maria Jose, Ostermann, Marlies, Herrmann, Sandra M, Abudayyeh, Ala, Anand, Shuchi, Glezerman, Ilya, Motwani, Shveta S, Murakami, Naoka, Wanchoo, Rimda, Ortiz-Melo, David I, Rashidi, Arash, Sprangers, Ben, Aggarwal, Vikram, Malik, A Bilal, Loew, Sebastian, Carlos, Christopher A, Chang, Wei-Ting, Beckerman, Pazit, Mithani, Zain, Shah, Chintan V, Renaghan, Amanda D, Seigneux, Sophie De, Campedel, Luca, Kitchlu, Abhijat, Shin, Daniel Sanghoon, Rangarajan, Sunil, Deshpande, Priya, Coppock, Gaia, Eijgelsheim, Mark, Seethapathy, Harish, Lee, Meghan D, Strohbehn, Ian A, Owen, Dwight H, Husain, Marium, Garcia-Carro, Clara, Bermejo, Sheila, Lumlertgul, Nuttha, Seylanova, Nina, Flanders, Lucy, Isik, Busra, Mamlouk, Omar, Lin, Jamie S, Garcia, Pablo, Kaghazchi, Aydin, Khanin, Yuriy, Kansal, Sheru K, Wauters, Els, Chandra, Sunandana, Schmidt-Ott, Kai M, Hsu, Raymond K, Tio, Maria C, Sarvode Mothi, Suraj, Singh, Harkarandeep, Schrag, Deborah, Jhaveri, Kenar D, Reynolds, Kerry L, Cortazar, Frank B, Leaf, David E, ICPi-AKI Consortium Investigators, Gupta, Shruti, Gupta, Shruti, Short, Samuel AP, Sise, Meghan E, Prosek, Jason M, Madhavan, Sethu M, Soler, Maria Jose, Ostermann, Marlies, Herrmann, Sandra M, Abudayyeh, Ala, Anand, Shuchi, Glezerman, Ilya, Motwani, Shveta S, Murakami, Naoka, Wanchoo, Rimda, Ortiz-Melo, David I, Rashidi, Arash, Sprangers, Ben, Aggarwal, Vikram, Malik, A Bilal, Loew, Sebastian, Carlos, Christopher A, Chang, Wei-Ting, Beckerman, Pazit, Mithani, Zain, Shah, Chintan V, Renaghan, Amanda D, Seigneux, Sophie De, Campedel, Luca, Kitchlu, Abhijat, Shin, Daniel Sanghoon, Rangarajan, Sunil, Deshpande, Priya, Coppock, Gaia, Eijgelsheim, Mark, Seethapathy, Harish, Lee, Meghan D, Strohbehn, Ian A, Owen, Dwight H, Husain, Marium, Garcia-Carro, Clara, Bermejo, Sheila, Lumlertgul, Nuttha, Seylanova, Nina, Flanders, Lucy, Isik, Busra, Mamlouk, Omar, Lin, Jamie S, Garcia, Pablo, Kaghazchi, Aydin, Khanin, Yuriy, Kansal, Sheru K, Wauters, Els, Chandra, Sunandana, Schmidt-Ott, Kai M, Hsu, Raymond K, Tio, Maria C, Sarvode Mothi, Suraj, Singh, Harkarandeep, Schrag, Deborah, Jhaveri, Kenar D, Reynolds, Kerry L, Cortazar, Frank B, Leaf, David E, and ICPi-AKI Consortium Investigators

Abstract

Immune checkpoint inhibitor-associated acute kidney injury (ICPi-AKI) has emerged as an important toxicity among patients with cancer. We collected data on 429 patients with ICPi-AKI and 429 control patients who received ICPis contemporaneously but who did not develop ICPi-AKI from 30 sites in 10 countries. Multivariable logistic regression was used to identify predictors of ICPi-AKI and its recovery. A multivariable Cox model was used to estimate the effect of ICPi rechallenge versus no rechallenge on survival following ICPi-AKI. ICPi-AKI occurred at a median of 16 weeks (IQR 8-32) following ICPi initiation. Lower baseline estimated glomerular filtration rate, proton pump inhibitor (PPI) use, and extrarenal immune-related adverse events (irAEs) were each associated with a higher risk of ICPi-AKI. Acute tubulointerstitial nephritis was the most common lesion on kidney biopsy (125/151 biopsied patients [82.7%]). Renal recovery occurred in 276 patients (64.3%) at a median of 7 weeks (IQR 3-10) following ICPi-AKI. Treatment with corticosteroids within 14 days following ICPi-AKI diagnosis was associated with higher odds of renal recovery (adjusted OR 2.64; 95% CI 1.58 to 4.41). Among patients treated with corticosteroids, early initiation of corticosteroids (within 3 days of ICPi-AKI) was associated with a higher odds of renal recovery compared with later initiation (more than 3 days following ICPi-AKI) (adjusted OR 2.09; 95% CI 1.16 to 3.79). Of 121 patients rechallenged, 20 (16.5%) developed recurrent ICPi-AKI. There was no difference in survival among patients rechallenged versus those not rechallenged following ICPi-AKI. Patients who developed ICPi-AKI were more likely to have impaired renal function at baseline, use a PPI, and have extrarenal irAEs. Two-thirds of patients had renal recovery following ICPi-AKI. Treatment with corticosteroids was associated with improved renal recovery.

Published
2021

5. A multi-center study on safety and efficacy of immune checkpoint inhibitors in cancer patients with kidney transplant.

Author

Murakami, Naoka, Murakami, Naoka, Mulvaney, Patrick, Danesh, Melissa, Abudayyeh, Ala, Diab, Adi, Abdel-Wahab, Noha, Abdelrahim, Maen, Khairallah, Pascale, Shirazian, Shayan, Kukla, Aleksandra, Owoyemi, Itunu O, Alhamad, Tarek, Husami, Samir, Menon, Madhav, Santeusanio, Andrew, Blosser, Christopher D, Zuniga, Sandra Carias, Soler, Maria Jose, Moreso, Francesc, Mithani, Zain, Ortiz-Melo, David, Jaimes, Edgar A, Gutgarts, Victoria, Lum, Erik, Danovitch, Gabriel M, Cardarelli, Francesca, Drews, Reed E, Bassil, Claude, Swank, Jennifer L, Westphal, Scott, Mannon, Roslyn B, Shirai, Keisuke, Kitchlu, Abhijat, Ong, Song, Machado, Shana M, Mothi, Suraj S, Ott, Patrick A, Rahma, Osama, Hodi, F Stephen, Sise, Meghan E, Gupta, Shruti, Leaf, David E, Devoe, Craig E, Wanchoo, Rimda, Nair, Vinay V, Schmults, Chrysalyne D, Hanna, Glenn J, Sprangers, Ben, Riella, Leonardo V, Jhaveri, Kenar D, Immune Checkpoint Inhibitors in Solid Organ Transplant Consortium, Murakami, Naoka, Murakami, Naoka, Mulvaney, Patrick, Danesh, Melissa, Abudayyeh, Ala, Diab, Adi, Abdel-Wahab, Noha, Abdelrahim, Maen, Khairallah, Pascale, Shirazian, Shayan, Kukla, Aleksandra, Owoyemi, Itunu O, Alhamad, Tarek, Husami, Samir, Menon, Madhav, Santeusanio, Andrew, Blosser, Christopher D, Zuniga, Sandra Carias, Soler, Maria Jose, Moreso, Francesc, Mithani, Zain, Ortiz-Melo, David, Jaimes, Edgar A, Gutgarts, Victoria, Lum, Erik, Danovitch, Gabriel M, Cardarelli, Francesca, Drews, Reed E, Bassil, Claude, Swank, Jennifer L, Westphal, Scott, Mannon, Roslyn B, Shirai, Keisuke, Kitchlu, Abhijat, Ong, Song, Machado, Shana M, Mothi, Suraj S, Ott, Patrick A, Rahma, Osama, Hodi, F Stephen, Sise, Meghan E, Gupta, Shruti, Leaf, David E, Devoe, Craig E, Wanchoo, Rimda, Nair, Vinay V, Schmults, Chrysalyne D, Hanna, Glenn J, Sprangers, Ben, Riella, Leonardo V, Jhaveri, Kenar D, and Immune Checkpoint Inhibitors in Solid Organ Transplant Consortium

Abstract

Immune checkpoint inhibitors (ICIs) are widely used for various malignancies. However, their safety and efficacy in patients with a kidney transplant have not been defined. To delineate this, we conducted a multicenter retrospective study of 69 patients with a kidney transplant receiving ICIs between January 2010 and May 2020. For safety, we assessed the incidence, timing, and risk factors of acute graft rejection. For efficacy, objective response rate and overall survival were assessed in cutaneous squamous cell carcinoma and melanoma, the most common cancers in our cohort, and compared with stage-matched 23 patients with squamous cell carcinoma and 14 with melanoma with a kidney transplant not receiving ICIs. Following ICI treatment, 29 out of 69 (42%) patients developed acute rejection, 19 of whom lost their allograft, compared with an acute rejection rate of 5.4% in the non-ICI cohort. Median time from ICI initiation to rejection was 24 days. Factors associated with a lower risk of rejection were mTOR inhibitor use (odds ratio 0.26; 95% confidence interval, 0.09-0.72) and triple-agent immunosuppression (0.67, 0.48-0.92). The objective response ratio was 36.4% and 40% in the squamous cell carcinoma and melanoma subgroups, respectively. In the squamous cell carcinoma subgroup, overall survival was significantly longer in patients treated with ICIs (median overall survival 19.8 months vs. 10.6 months), whereas in the melanoma subgroup, overall survival did not differ between groups. Thus, ICIs were associated with a high risk of rejection in patients with kidney transplants but may lead to improved cancer outcomes. Prospective studies are needed to determine optimal immunosuppression strategies to improve patient outcomes.

Published
2021

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