Contributions
Abstract: EP1737
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Alemtuzumab is an effective therapeutic option for patients with active relapsing-remitting multiple sclerosis (RRMS). Its adverse event profile mainly comprises development of secondary autoimmune disorders and infusion-associated reactions (IARs). The latter mostly manifests with headache, pyrexia and rash, but also rarely includes hypotension, cardiac arrhythmia, and anaphylactic shock. IARs are usually limited to the first days of infusion and - if managed properly - do not cause sustained impairment.
We recently described acalculous cholecystitis (AAC) as a novel, but rare IAR. AAC itself is usually seen in intensive-care-unit (ICU) patients suffering from septicemia following surgery and in end-stage HIV infections. Furthermore, AAC has been a complication of infectious (e.g. Epstein-Barr virus or cytomegalovirus infection) or inflammatory disorders (e.g. systemic lupus erythematosus, Sjögren's syndrome). Diagnosis is often rendered difficult due to unspecific symptoms such as upper right quadrant stomach pain, pyrexia and inconclusive laboratory findings (e.g., often normal levels of alkaline phosphatase). Precise treatment is crucial given the high mortality of about one third of patients.
Among the 180 infusion courses that were administered to around 100 patients in our department between 2015 and 2016, we detected 4 cases of AAC. All cases were confirmed using CT and/or ultrasound imaging. In contrast to our previous experience, this condition is not always limited to the first days of infusion and was converted to chronic gall bladder inflammation in two cases. Furthermore, AAC did not occur as a single event and was detectable also after repetitive courses of Alemtuzumab in the three patients that did not undergo cholecystectomy. In one patient requiring cholecystectomy, histopathology demonstrated lymphocyte invasion in the gallbladder.
These findings require careful consideration on whether the appearance of AAC in alemtuzumab patients should lead to subsequent cholecystectomy. Facing the potential risk of chronic gall bladder inflammation, monitoring should include clinical surveillance for this condition. Generally, physicians should be aware of this IAR and seek contact to gastroenterologists or surgeons in suspicious cases.
This project is supported financially by Sanofi Genzyme
Disclosure:
Steffen Pfeuffer received travel reimbursements and lecturing honoraria from Sanofi Genzyme and Biogen.
Tobias Ruck received travel reimbursements and financial research support from Sanofi Genzyme and Novartis and lecturing honoraria from Sanofi Genzyme, Biogen and Teva.
Carolin Beuker and Frank Lenze report no disclosures.
Heinz Wiendl received compensation for serving on Scientific Advisory Boards/Steering Committees, for Bayer Healthcare, Biogen Idec, Sanofi Genzyme, Merck Serono and Novartis, lecturing honoraria and travel reimbursements from Bayer Vital, Bayer Schering, Biogen, CSL Behring, EMD Serono, Fresenius Medical Care, Sanofi Genzyme, Merck Serono, Omniamed, Novartis and Sanofi Aventis, compensation as a consultant from Biogen Idec, Merck Serono, Novartis, Roche and Sanofi Genzyme, financial research support from Bayer Healthcare, Bayer Vital, Biogen Idec, Merck Serono, Novartis, Sanofi Genzyme, Sanofi US and TEVA Pharma.
Nico Melzer received lecturing honoraria and travel reimbursements Biogen Idec, GlaxoSmith Kline, Teva, Novartis Pharma, Bayer Healthcare, and Fresenius Medical Care and financial research support from Fresenius Medical Care.
Sven G. Meuth received lecturing honoraria, travel reimbursements and financial research support from Bayer, Bayer Schering, Biogen Idec, Sanofi Genzyme, Merck Serono, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi-Aventis and Teva.
Abstract: EP1737
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Alemtuzumab is an effective therapeutic option for patients with active relapsing-remitting multiple sclerosis (RRMS). Its adverse event profile mainly comprises development of secondary autoimmune disorders and infusion-associated reactions (IARs). The latter mostly manifests with headache, pyrexia and rash, but also rarely includes hypotension, cardiac arrhythmia, and anaphylactic shock. IARs are usually limited to the first days of infusion and - if managed properly - do not cause sustained impairment.
We recently described acalculous cholecystitis (AAC) as a novel, but rare IAR. AAC itself is usually seen in intensive-care-unit (ICU) patients suffering from septicemia following surgery and in end-stage HIV infections. Furthermore, AAC has been a complication of infectious (e.g. Epstein-Barr virus or cytomegalovirus infection) or inflammatory disorders (e.g. systemic lupus erythematosus, Sjögren's syndrome). Diagnosis is often rendered difficult due to unspecific symptoms such as upper right quadrant stomach pain, pyrexia and inconclusive laboratory findings (e.g., often normal levels of alkaline phosphatase). Precise treatment is crucial given the high mortality of about one third of patients.
Among the 180 infusion courses that were administered to around 100 patients in our department between 2015 and 2016, we detected 4 cases of AAC. All cases were confirmed using CT and/or ultrasound imaging. In contrast to our previous experience, this condition is not always limited to the first days of infusion and was converted to chronic gall bladder inflammation in two cases. Furthermore, AAC did not occur as a single event and was detectable also after repetitive courses of Alemtuzumab in the three patients that did not undergo cholecystectomy. In one patient requiring cholecystectomy, histopathology demonstrated lymphocyte invasion in the gallbladder.
These findings require careful consideration on whether the appearance of AAC in alemtuzumab patients should lead to subsequent cholecystectomy. Facing the potential risk of chronic gall bladder inflammation, monitoring should include clinical surveillance for this condition. Generally, physicians should be aware of this IAR and seek contact to gastroenterologists or surgeons in suspicious cases.
This project is supported financially by Sanofi Genzyme
Disclosure:
Steffen Pfeuffer received travel reimbursements and lecturing honoraria from Sanofi Genzyme and Biogen.
Tobias Ruck received travel reimbursements and financial research support from Sanofi Genzyme and Novartis and lecturing honoraria from Sanofi Genzyme, Biogen and Teva.
Carolin Beuker and Frank Lenze report no disclosures.
Heinz Wiendl received compensation for serving on Scientific Advisory Boards/Steering Committees, for Bayer Healthcare, Biogen Idec, Sanofi Genzyme, Merck Serono and Novartis, lecturing honoraria and travel reimbursements from Bayer Vital, Bayer Schering, Biogen, CSL Behring, EMD Serono, Fresenius Medical Care, Sanofi Genzyme, Merck Serono, Omniamed, Novartis and Sanofi Aventis, compensation as a consultant from Biogen Idec, Merck Serono, Novartis, Roche and Sanofi Genzyme, financial research support from Bayer Healthcare, Bayer Vital, Biogen Idec, Merck Serono, Novartis, Sanofi Genzyme, Sanofi US and TEVA Pharma.
Nico Melzer received lecturing honoraria and travel reimbursements Biogen Idec, GlaxoSmith Kline, Teva, Novartis Pharma, Bayer Healthcare, and Fresenius Medical Care and financial research support from Fresenius Medical Care.
Sven G. Meuth received lecturing honoraria, travel reimbursements and financial research support from Bayer, Bayer Schering, Biogen Idec, Sanofi Genzyme, Merck Serono, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi-Aventis and Teva.