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Article ; Online: Noncardiac Manifestations of Hereditary Amyloidosis.

Khella, Sami L

2022 Volume 185 Suppl 1, Page(s) S17–S22

Abstract: The most common forms of cardiac amyloidosis are progressive, life threatening, and underrecognized. Symptoms affect a variety of organs and overlap with those of more common conditions, complicating and postponing diagnosis. Cardiac disease generally ... ...

Abstract	The most common forms of cardiac amyloidosis are progressive, life threatening, and underrecognized. Symptoms affect a variety of organs and overlap with those of more common conditions, complicating and postponing diagnosis. Cardiac disease generally determines mortality, but noncardiac manifestations typically surface before cardiac symptoms, often several years before diagnosis. Familiarity with noncardiac manifestations may lead to early diagnosis, enabling treatment and improving prognosis.
MeSH term(s)	Humans ; Amyloidosis/complications ; Amyloidosis/diagnosis ; Amyloidosis/therapy ; Amyloidosis, Familial ; Prognosis ; Heart Diseases/diagnosis ; Heart Diseases/etiology
Language	English
Publishing date	2022-11-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	80014-4
ISSN	1879-1913 ; 0002-9149
ISSN (online)	1879-1913
ISSN	0002-9149
DOI	10.1016/j.amjcard.2022.10.007
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Book: Neurology

Souayah, Nizar / Khella, Sami

examination & board review

(McGraw-Hill specialty board review)

2005

Author's details	Nizar Souayah ; Sami Khella
Series title	McGraw-Hill specialty board review
Keywords	Nervous System Diseases ; Neurology ; Neurology/Examinations
Subject code	616.8
Language	English
Size	VII, 325 S., [4] Bl. : Ill.
Publisher	McGraw-Hill
Publishing place	New York u.a.
Publishing country	United States
Document type	Book
HBZ-ID	HT014492321
ISBN	0-07-137839-1 ; 978-0-07-137839-0
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2005 A 4320	order for loan	Magazin

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Article ; Online: The impact of inotersen on Neuropathy Impairment Score in patients with hereditary transthyretin amyloidosis with polyneuropathy.

Yarlas, Aaron / Lovley, Andrew / Brown, Duncan / Vera-Llonch, Montserrat / Khella, Sami / Karam, Chafic

BMC neurology

2023 Volume 23, Issue 1, Page(s) 108

Abstract: Background: Patients with hereditary transthyretin amyloidosis (ATTRv) frequently experience symptoms of polyneuropathy (PN) that worsen over time and impair daily functioning. Previous analyses supported efficacy of inotersen, an antisense ... ...

Abstract	Background: Patients with hereditary transthyretin amyloidosis (ATTRv) frequently experience symptoms of polyneuropathy (PN) that worsen over time and impair daily functioning. Previous analyses supported efficacy of inotersen, an antisense oligonucleotide, to slow neuropathic progression in patients with ATTRv-PN, as indicated by larger mean changes, relative to placebo, in total score and several subscales of the Neuropathy Impairment Score (NIS), and for the subset of NIS items specific to lower limbs (NIS-LL) for the overall study sample. A key objective of the current study was to evaluate efficacy of inotersen for slowing neuropathic progression in NIS/NIS-LL within key clinical subgroups of patients with ATTRv-PN. Additionally, for this study, responder definition (RD) thresholds were estimated for NIS/NIS-LL total and subscale scores, for the purpose of evaluating clinically meaningful benefit of inotersen at the individual patient-level. Methods: Post hoc analyses used data from the NEURO-TTR phase 3 trial of inotersen in patients with ATTRv-PN (NCT01737398). Treatment differences in mean changes on NIS/NIS-LL total and subscale scores from baseline to week 65 were examined within patient subgroups defined by clinical characteristics. Anchor- and distribution-based approaches estimated RDs for NIS/NIS-LL scores, with responders defined as patients who did not experience clinically meaningful neuropathic progression. Responder analyses compared the proportion of patients classified as responders for each NIS/NIS-LL score between treatment arms. Results: Within each patient subgroup, mean increases in NIS/NIS-LL total and muscle weakness subscales were significantly smaller after 65 weeks of treatment with inotersen compared to placebo. Similar patterns were observed for some, but not all, subgroups on NIS/NIS-LL reflex subscale scores. Recommended RDs were 8.1 points for NIS total and 4.7 points for NIS-LL total. Patients receiving inotersen for 65 weeks were significantly less likely than those receiving placebo to exhibit clinically meaningful increases on NIS/NIS-LL total, muscle weakness, and sensation subscales. Conclusions: This study supports previous evidence for efficacy of inotersen in this patient population and provides interpretation guidelines for clinically meaningful changes in NIS/NIS-LL scores.
MeSH term(s)	Humans ; Amyloid Neuropathies, Familial/complications ; Amyloid Neuropathies, Familial/drug therapy ; Muscle Weakness ; Polyneuropathies/diagnosis ; Polyneuropathies/drug therapy
Chemical Substances	Inotersen (0IEO0F56LV)
Language	English
Publishing date	2023-03-17
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2041347-6
ISSN	1471-2377 ; 1471-2377
ISSN (online)	1471-2377
ISSN	1471-2377
DOI	10.1186/s12883-023-03116-7
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Article ; Online: Screening for ATTR amyloidosis in the clinic: overlapping disorders, misdiagnosis, and multiorgan awareness.

Nativi-Nicolau, Jose N / Karam, Chafic / Khella, Sami / Maurer, Mathew S

Heart failure reviews

2021 Volume 27, Issue 3, Page(s) 785–793

Abstract: Amyloid transthyretin (ATTR) amyloidosis is a clinically heterogeneous and fatal disease that results from deposition of insoluble amyloid fibrils in various organs and tissues, causing progressive loss of function. The objective of this review is to ... ...

Abstract	Amyloid transthyretin (ATTR) amyloidosis is a clinically heterogeneous and fatal disease that results from deposition of insoluble amyloid fibrils in various organs and tissues, causing progressive loss of function. The objective of this review is to increase awareness and diagnosis of ATTR amyloidosis by improving recognition of its overlapping conditions, misdiagnosis, and multiorgan presentation. Cardiac manifestations include heart failure, atrial fibrillation, intolerance to previously prescribed antihypertensives, sinus node dysfunction, and atrioventricular block, resulting in the need for permanent pacing. Neurologic manifestations include progressive sensorimotor neuropathy (e.g., pain, weakness) and autonomic dysfunction (e.g., erectile dysfunction, chronic diarrhea, orthostatic hypotension). Non-cardiac red flags often precede the diagnosis of ATTR amyloidosis and include musculoskeletal manifestations (e.g., carpal tunnel syndrome, lumbar spinal stenosis, spontaneous rupture of the distal tendon biceps, shoulder and knee surgery). Awareness and recognition of the constellation of symptoms, including cardiac, neurologic, and musculoskeletal manifestations, will help with early diagnosis of ATTR amyloidosis and faster access to therapies, thereby slowing the progression of this debilitating disease.
MeSH term(s)	Amyloid ; Amyloid Neuropathies, Familial/complications ; Amyloid Neuropathies, Familial/diagnosis ; Diagnostic Errors ; Humans ; Male ; Prealbumin
Chemical Substances	Amyloid ; Prealbumin
Language	English
Publishing date	2021-02-20
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	1336499-6
ISSN	1573-7322 ; 1382-4147
ISSN (online)	1573-7322
ISSN	1382-4147
DOI	10.1007/s10741-021-10080-2
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Article ; Online: Artist's statement: Woe.

Khella, Sami

Academic medicine : journal of the Association of American Medical Colleges

2010 Volume 85, Issue 9, Page(s) 1404

MeSH term(s)	Humans ; Medicine in the Arts ; Physician-Patient Relations ; Stress, Psychological
Language	English
Publishing date	2010-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	96192-9
ISSN	1938-808X ; 1040-2446
ISSN (online)	1938-808X
ISSN	1040-2446
DOI	10.1097/ACM.0b013e3181eade92
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Article ; Online: Single institution experience with efgartigimod in patients with myasthenia gravis: Patient selection, dosing schedules, treatment response, and adverse events.

Singer, Madeline / Khella, Sami / Bird, Shawn / McIntosh, Paul / Paudyal, Bandhu / Wadhwani, Anil / Quinn, Colin / Karam, Chafic

Muscle & nerve

2023 Volume 69, Issue 1, Page(s) 87–92

Abstract: Introduction/aims: Efgartigimod is a neonatal Fc receptor blocker and was the first approved medication in its class for the treatment of generalized myasthenia gravis (gMG). As a novel therapy, little is known about the use of efgartigimod in clinical ... ...

Abstract	Introduction/aims: Efgartigimod is a neonatal Fc receptor blocker and was the first approved medication in its class for the treatment of generalized myasthenia gravis (gMG). As a novel therapy, little is known about the use of efgartigimod in clinical practice. This study aims to describe how efgartigimod is being incorporated into the current therapeutic landscape of MG. Methods: We reviewed the charts of 17 patients with gMG treated with efgartigimod at the University of Pennsylvania between January 2022 and June 2023. Results: Efgartigimod was selected mainly for patients who were treatment refractory, had side effects to other treatments, and/or required quick improvement in their symptoms. All patients had been previously treated with at least one medication for MG and had an average baseline Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 9.1. The patients treated with efgartigimod improved their MG-ADL score by an average of 5.5 points at 3 months (p < .001) and 7.1 points by 6 months (p < .001). Forty percent of patients achieved minimal symptom expression. Adverse events (AEs) were reported in 43.7% of patients on efgartigimod, the most common being mild infection (urinary tract infection and thrush). There were no serious AEs. Discussion: This study found efgartigimod to be efficacious, well tolerated, and safe in patients with MG. Efgartigimod should be considered as an add-on therapy, a bridge therapy, or as a monotherapy if patients have difficulty tolerating other treatments.
MeSH term(s)	Infant, Newborn ; Humans ; Patient Selection ; Activities of Daily Living ; Myasthenia Gravis/drug therapy ; Behavior Therapy ; Autoantibodies
Chemical Substances	Autoantibodies
Language	English
Publishing date	2023-11-21
Publishing country	United States
Document type	Review ; Journal Article
ZDB-ID	438353-9
ISSN	1097-4598 ; 0148-639X
ISSN (online)	1097-4598
ISSN	0148-639X
DOI	10.1002/mus.28003
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Article ; Online: New insights into stroke in chronic kidney disease.

Khella, Sami L

Advances in chronic kidney disease

2008 Volume 15, Issue 4, Page(s) 338–346

Abstract: Patients with chronic kidney disease (CKD) are predisposed to stroke, especially as the estimated glomerular filtration rate decreases. This update reviews the pathologic mechanisms particular to this stroke population. The treatment for primary and ... ...

Abstract	Patients with chronic kidney disease (CKD) are predisposed to stroke, especially as the estimated glomerular filtration rate decreases. This update reviews the pathologic mechanisms particular to this stroke population. The treatment for primary and secondary prevention of stroke is reviewed with respect to antiplatelet agents, anticoagulants, surgery, and carotid stenting. The control of chronic hypertension is particularly important in reducing stroke risk in CKD. In patients with prior stroke from atherosclerosis, antiplatelet agents are most beneficial in reducing secondary stroke risk. Those with atrial fibrillation and CKD may benefit from warfarin anticoagulation. Statins in CKD for stroke reduction in diabetics receiving dialysis are not useful, and the data are pending for their use in stroke reduction in the general CKD population. In carefully selected cases, carotid endarterectomy can be a treatment. The data on carotid stenting are conflicting.
MeSH term(s)	Age Distribution ; Aged ; Anticoagulants/therapeutic use ; Antihypertensive Agents/therapeutic use ; Blood Pressure Determination ; Comorbidity ; Drug Therapy, Combination ; Female ; Humans ; Hypertension/diagnosis ; Hypertension/drug therapy ; Hypertension/epidemiology ; Incidence ; Kidney Failure, Chronic/diagnosis ; Kidney Failure, Chronic/epidemiology ; Kidney Failure, Chronic/therapy ; Male ; Middle Aged ; Platelet Aggregation Inhibitors/therapeutic use ; Prognosis ; Risk Assessment ; Severity of Illness Index ; Sex Distribution ; Stroke/drug therapy ; Stroke/epidemiology ; Stroke/prevention & control ; Survival Analysis
Chemical Substances	Anticoagulants ; Antihypertensive Agents ; Platelet Aggregation Inhibitors
Language	English
Publishing date	2008-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ISSN	1548-5609 ; 1548-5595
ISSN (online)	1548-5609
ISSN	1548-5595
DOI	10.1053/j.ackd.2008.07.002
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Article ; Online: Precision targeting of autoantigen-specific B cells in muscle-specific tyrosine kinase myasthenia gravis with chimeric autoantibody receptor T cells.

Oh, Sangwook / Mao, Xuming / Manfredo-Vieira, Silvio / Lee, Jinmin / Patel, Darshil / Choi, Eun Jung / Alvarado, Andrea / Cottman-Thomas, Ebony / Maseda, Damian / Tsao, Patricia Y / Ellebrecht, Christoph T / Khella, Sami L / Richman, David P / O'Connor, Kevin C / Herzberg, Uri / Binder, Gwendolyn K / Milone, Michael C / Basu, Samik / Payne, Aimee S

Nature biotechnology

2023 Volume 41, Issue 9, Page(s) 1229–1238

Abstract: Muscle-specific tyrosine kinase myasthenia gravis (MuSK MG) is an autoimmune disease that causes life-threatening muscle weakness due to anti-MuSK autoantibodies that disrupt neuromuscular junction signaling. To avoid chronic immunosuppression from ... ...

Abstract	Muscle-specific tyrosine kinase myasthenia gravis (MuSK MG) is an autoimmune disease that causes life-threatening muscle weakness due to anti-MuSK autoantibodies that disrupt neuromuscular junction signaling. To avoid chronic immunosuppression from current therapies, we engineered T cells to express a MuSK chimeric autoantibody receptor with CD137-CD3ζ signaling domains (MuSK-CAART) for precision targeting of B cells expressing anti-MuSK autoantibodies. MuSK-CAART demonstrated similar efficacy as anti-CD19 chimeric antigen receptor T cells for depletion of anti-MuSK B cells and retained cytolytic activity in the presence of soluble anti-MuSK antibodies. In an experimental autoimmune MG mouse model, MuSK-CAART reduced anti-MuSK IgG without decreasing B cells or total IgG levels, reflecting MuSK-specific B cell depletion. Specific off-target interactions of MuSK-CAART were not identified in vivo, in primary human cell screens or by high-throughput human membrane proteome array. These data contributed to an investigational new drug application and phase 1 clinical study design for MuSK-CAART for the treatment of MuSK autoantibody-positive MG.
MeSH term(s)	Humans ; Mice ; Animals ; Receptors, Cholinergic/therapeutic use ; Autoantigens/therapeutic use ; Myasthenia Gravis, Autoimmune, Experimental/drug therapy ; T-Lymphocytes ; Autoantibodies/therapeutic use ; Immunoglobulin G ; Protein-Tyrosine Kinases/therapeutic use ; Muscles
Chemical Substances	Receptors, Cholinergic ; Autoantigens ; Autoantibodies ; Immunoglobulin G ; Protein-Tyrosine Kinases (EC 2.7.10.1)
Language	English
Publishing date	2023-01-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1311932-1
ISSN	1546-1696 ; 1087-0156
ISSN (online)	1546-1696
ISSN	1087-0156
DOI	10.1038/s41587-022-01637-z
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Article ; Online: Inotersen for the treatment of adults with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis.

Gertz, Morie A / Scheinberg, Morton / Waddington-Cruz, Márcia / Heitner, Stephen B / Karam, Chafic / Drachman, Brian / Khella, Sami / Whelan, Carol / Obici, Laura

Expert review of clinical pharmacology

2019 Volume 12, Issue 8, Page(s) 701–711

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Adult ; Amyloid Neuropathies, Familial/drug therapy ; Amyloid Neuropathies, Familial/genetics ; Amyloid Neuropathies, Familial/physiopathology ; Animals ; Humans ; Mutation ; Oligodeoxyribonucleotides, Antisense/adverse effects ; Oligodeoxyribonucleotides, Antisense/pharmacology ; Oligodeoxyribonucleotides, Antisense/therapeutic use ; Oligonucleotides/adverse effects ; Oligonucleotides/pharmacology ; Oligonucleotides/therapeutic use ; Polyneuropathies/drug therapy ; Polyneuropathies/etiology ; Prealbumin/genetics ; Quality of Life
Chemical Substances	Oligodeoxyribonucleotides, Antisense ; Oligonucleotides ; Prealbumin ; TTR protein, human ; Inotersen (0IEO0F56LV)
Language	English
Publishing date	2019-07-03
Publishing country	England
Document type	Journal Article ; Review
ISSN	1751-2441
ISSN (online)	1751-2441
DOI	10.1080/17512433.2019.1635008
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Article: Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR.

Yarlas, Aaron / Lovley, Andrew / McCausland, Kristen / Brown, Duncan / Vera-Llonch, Montserrat / Conceição, Isabel / Karam, Chafic / Khella, Sami / Obici, Laura / Waddington-Cruz, Márcia

Neurology and therapy

2021 Volume 10, Issue 2, Page(s) 865–886

Abstract: Introduction: Patients with hereditary transthyretin amyloidosis associated with polyneuropathy (ATTRv-PN) experience deterioration in health-related quality of life (HRQOL) as the disease progresses. Findings from the randomized placebo-controlled ... ...

Abstract	Introduction: Patients with hereditary transthyretin amyloidosis associated with polyneuropathy (ATTRv-PN) experience deterioration in health-related quality of life (HRQOL) as the disease progresses. Findings from the randomized placebo-controlled phase III NEURO-TTR study showed treatment benefit of inotersen, an antisense oligonucleotide, for preserving or improving HRQOL after 65 weeks of treatment. The current analysis examines longitudinal trends in specific aspects of HRQOL, including polyneuropathy symptoms, daily activities, and physical, role, and social functioning in patients with ATTRv-PN receiving long-term treatment in a follow-up open-label extension (OLE) study. Methods: One-hundred thirty-five patients with ATTRv-PN were enrolled in an ongoing 5-year OLE study following completion of NEURO-TTR. Eighty-five patients received continuous weekly treatment with inotersen in both studies (inotersen-inotersen group), while 50 patients switched from placebo to inotersen at OLE study baseline (placebo-inotersen group). Descriptive analyses of changes in domain scores and item responses through week 104 of the OLE study were conducted for measures of neuropathy-related and generic HRQOL: Norfolk QOL-Diabetic Neuropathy (DN) questionnaire and SF-36v2® Health Survey (SF-36v2), respectively. Results: For both inotersen-inotersen and placebo-inotersen groups, all Norfolk QOL-DN and most SF-36v2 domain scores remained stable from OLE baseline through week 104. Differences in HRQOL between the two groups at OLE baseline were sustained through week 104. Analysis of item responses from NEURO-TTR baseline to OLE study week 104 (170 weeks) for the inotersen-inotersen group found no notable increases in the proportion of patients reporting substantial impairments across a wide variety of symptoms, daily activities, and functioning. Conclusion: Long-term treatment with inotersen preserved HRQOL for patients with ATTRv-PN for periods of up to 3 years. The gap in HRQOL between those who had previously received inotersen or placebo in NEURO-TTR did not close by week 104 of the OLE phase, indicating the importance of early treatment for maintaining HRQOL in these patients. Trial registration: ClinicalTrials.gov Identifiers NCT01737398 for NEURO-TTR study; NCT02175004 for OLE study INFOGRAPHIC.
Language	English
Publishing date	2021-08-05
Publishing country	New Zealand
Document type	Journal Article
ISSN	2193-8253
ISSN	2193-8253
DOI	10.1007/s40120-021-00268-x
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