Author: "Musallam, KM" / Publication Year Range: Last 50 years - Searchworks@Jio Institute Digital Library Search Results

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229 results on '"Musallam, KM"'

1. Profile of Luspatercept in the Treatment of Anemia in Adults with Non-Transfusion-Dependent β-Thalassemia (NTDT): Design, Development and Potential Place in Therapy

Author: Musallam KM, Taher AT, Kattamis A, Kuo KH, Sheth S, and Cappellini MD
Subjects: anemia, ineffective erythropoiesis, iron, management, thalassemia, transfusion., Therapeutics. Pharmacology, RM1-950
Abstract: Khaled M Musallam,1 Ali T Taher,2 Antonis Kattamis,3 Kevin HM Kuo,4 Sujit Sheth,5 Maria Domenica Cappellini6 1Thalassemia Center, Burjeel Medical City, Abu Dhabi, United Arab Emirates; 2Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon; 3First Department of Pediatrics, National and Kapodistrian University of Athens, Athens, Greece; 4Division of Hematology, University of Toronto, Toronto, ON, Canada; 5Division of Hematology and Oncology, Department of Pediatrics, Weill Cornell Medicine, New York, NY, USA; 6Department of Clinical Sciences and Community, University of Milan, Ca’ Granda Foundation IRCCS Maggiore Policlinico Hospital, Milan, ItalyCorrespondence: Maria Domenica Cappellini, Department of Clinical Sciences and Community, University of Milan, Ca’ Granda Foundation IRCCS Maggiore Policlinico Hospital, Milan, 20122, Italy, Tel + 39 02 5503 3752, Email maria.cappellini@unimit.itAbstract: Over the past decade, evidence has been mounting on the detrimental clinical sequelae of untreated anemia in patients with non-transfusion-dependent β-thalassemia (NTDT). There are no pharmacologic agents that are specifically approved for the management of anemia in NTDT, and available options such as splenectomy, transfusion therapy, and hydroxyurea each come with their own shortcomings, especially for long-term use. Luspatercept is an erythroid maturation agent that has been evaluated in a Phase 2, randomized trial and showed a significant benefit in raising hemoglobin level by at least 1 g/dL in adults with NTDT and a baseline hemoglobin level ≤ 10 g/dL. These data led to luspatercept’s approval by the European Commission for the treatment of anemia in adults with NTDT and presents the first evidence-based approach for a novel agent that is able to ameliorate anemia in this patient population.Keywords: anemia, ineffective erythropoiesis, iron, management, thalassemia, transfusion
Published: 2023

2. Burden of disease scenarios for 204 countries and territories, 2022-2050: a forecasting analysis for the Global Burden of Disease Study 2021

Author: Vollset, SE, Ababneh, HS, Abate, YH, Abbafati, C, Abbasgholizadeh, R, Abbasian, M, Abbastabar, H, Abd Al Magied, AHA, Abd ElHafeez, S, Abdelkader, A, Abdelmasseh, M, Abd-Elsalam, S, Abdi, P, Abdollahi, M, Abdoun, M, Abdullahi, A, Abebe, M, Abiodun, O, Aboagye, RG, Abolhassani, H, Abouzid, M, Aboye, GB, Abreu, LG, Absalan, A, Abualruz, H, Abubakar, B, Abukhadijah, HJJ, Addolorato, G, Adekanmbi, V, Adetunji, CO, Adetunji, JB, Adeyeoluwa, TE, Adha, R, Adhikary, RK, Adnani, QES, Adzigbli, LA, Afrashteh, F, Afzal, MS, Afzal, S, Agbozo, F, Agodi, A, Agrawal, A, Agyemang-Duah, W, Ahinkorah, BO, Ahlstrom, AJ, Ahmad, A, Ahmad, F, Ahmad, MM, Ahmad, S, Ahmed, A, Ahmed, H, Ahmed, S, Ahmed, SA, Akinosoglou, K, Akkaif, MA, Akrami, AE, Akter, E, Al Awaidy, S, Al Hasan, SM, Al Mosa, AS, Al Ta'ani, O, Al Zaabi, OAM, Alahdab, F, Alajlani, MM, Al-Ajlouni, Y, Alalalmeh, SO, Al-Aly, Z, Alam, K, Alam, N, Alam, T, Alam, Z, Al-Amer, RM, Alanezi, FM, Alanzi, TM, Albakri, A, Aldhaleei, WA, Aldridge, RW, Alemohammad, SY, Alemu, YM, Al-Gheethi, AAS, Al-Hanawi, MK, Ali, A, Ali, I, Ali, MU, Ali, R, Ali, SSS, Ali, VE, Ali, W, Al-Ibraheem, A, Alicandro, G, Alif, SM, Aljunid, SM, Alla, F, Almazan, JU, Al-Mekhlafi, HM, Alqutaibi, AY, Alrawashdeh, A, Alrousan, SM, Al-Sabah, SK, Alsabri, MA, Altaany, Z, Al-Tammemi, AB, Al-Tawfiq, JA, Altirkawi, KA, Aluh, DO, Alvis-Guzman, N, Al-Wardat, MS, Al-Worafi, YM, Aly, H, Alyahya, MS, Alzoubi, KH, Al-Zyoud, W, Amani, R, Ameyaw, EK, Amin, TT, Amindarolzarbi, A, Amiri, S, Amirzade-Iranaq, MH, Amu, H, Amugsi, DA, Ancuceanu, R, Anderlini, D, Anderson, DB, Andrade, PP, Andrei, CL, Andrei, T, Andrews, EA, Anil, A, Anil, S, Anoushiravani, A, Antony, CM, Antriyandarti, E, Anuoluwa, BS, Anvari, S, Anyasodor, AE, Appiah, F, Aquilano, M, Arab, JP, Arabloo, J, Arafa, EA, Arafat, M, Aravkin, AY, Ardekani, A, Areda, D, Aregawi, BB, Aremu, A, Ariffin, H, Arkew, M, Armani, K, Artamonov, AA, Arumugam, A, Asghari-Jafarabadi, M, Ashbaugh, C, Astell-Burt, T, Athari, SS, Atorkey, P, Atout, MMW, Aujayeb, A, Ausloos, M, Awad, H, Awotidebe, AW, Ayatollahi, H, Ayuso-Mateos, JL, Azadnajafabad, S, Azeez, FK, Azevedo, RMS, Badar, M, Baghdadi, S, Bagheri, M, Bagheri, N, Bai, R, Baker, JL, Bako, AT, Balakrishnan, S, Balcha, WF, Baltatu, OC, Barchitta, M, Bardideh, E, Barker-Collo, SL, Barnighausen, TW, Barqawi, HJ, Barteit, S, Basiru, A, Basso, JD, Bastan, M-M, Basu, S, Bauckneht, M, Baune, BT, Bayati, M, Bayileyegn, NS, Behnoush, AH, Behzadi, P, Beiranvand, M, Bello, OO, Belo, L, Beloukas, A, Bemanalizadeh, M, Bensenor, IM, Benzian, H, Beran, A, Berezvai, Z, Bernstein, RS, Bettencourt, PJG, Beyene, KA, Beyene, MG, Bhagat, DS, Bhagavathula, AS, Bhala, N, Bhandari, D, Bharadwaj, R, Bhardwaj, N, Bhardwaj, P, Bhargava, A, Bhaskar, S, Bhat, V, Bhattacharjee, NV, Bhatti, GK, Bhatti, JS, Bhatti, MS, Bhuiyan, MA, Bisignano, C, Biswas, B, Bjorge, T, Bodolica, V, Bodunrin, AO, Hashemi, MB, Basara, BB, Borhany, H, Bosoka, SA, Carvajal, AB, Bouaoud, S, Boufous, S, Boxe, C, Boyko, EJ, Brady, OJ, Braithwaite, D, Brauer, M, Brazo-Sayavera, J, Brenner, H, Brown, CS, Browne, AJ, Brugha, T, Bryazka, D, Bulamu, NB, Buonsenso, D, Burkart, K, Burns, RA, Busse, R, Bustanji, Y, Butt, ZA, dos Santos, FLC, Barsbay, MC, Calina, D, Campos, LA, Cao, S, Capodici, A, Cardenas, R, Carreras, G, Carugno, A, Carvalho, M, Castaldelli-Maia, JM, Castelpietra, G, Cattaruzza, MS, Caye, A, Cegolon, L, Cembranel, F, Cenko, E, Cerin, E, Chadban, SJ, Chadwick, J, Chakraborty, C, Chakraborty, S, Chalek, J, Chan, JSK, Chandika, RM, Chandy, S, Charan, J, Chaudhary, AA, Chaurasia, A, Chen, A-T, Chen, H, Chen, MX, Chen, S, Cherbuin, N, Chi, G, Chichagi, F, Chimed-Ochir, O, Chimoriya, R, Ching, PR, Chirinos-Caceres, JL, Chitheer, A, Cho, DY, Cho, WCS, Choi, D-W, Chong, B, Chong, CL, Chopra, H, Chu, D-T, Chung, E, Chutiyami, M, Clayton, JT, Cogen, RM, Cohen, AJ, Columbus, A, Comfort, H, Conde, J, Connolly, JT, Cooper, EEK, Cortese, S, Cruz-Martins, N, da Silva, AG, Dadras, O, Dai, X, Dai, Z, Dalton, BE, Damiani, G, Dandona, L, Dandona, R, Das, JK, Das, S, Dash, NR, Davletov, K, De la Hoz, FP, De Leo, D, Debopadhaya, S, Delgado-Enciso, I, Denova-Gutierrez, E, Dervenis, N, Desai, HD, Devanbu, VGC, Dewan, SMR, Dhama, K, Dhane, AS, Dhingra, S, da Silva, DD, Diaz, D, Diaz, LA, Diaz, MJ, Dima, A, Ding, DD, Do, THP, Do Prado, CB, Dodangeh, M, Doegah, PT, Dohare, S, Dong, W, D'Oria, M, Doshi, R, Dowou, RK, Dsouza, HL, Dsouza, V, Dube, J, Dumith, SC, Duncan, BB, Duraes, AR, Duraisamy, S, Durojaiye, OC, Dushpanova, A, Dutta, S, Dzianach, PA, Dziedzic, AM, Eboreime, E, Ebrahimi, A, Kalan, ME, Edinur, HA, Efendi, F, Eikemo, TA, Eini, E, Ekundayo, TC, El Arab, RA, El Sayed, I, Elamin, O, Elemam, NM, ElGohary, GMT, Elhadi, M, Elmeligy, OAA, Elmoselhi, AB, Elshaer, M, Elsohaby, I, Eltahir, ME, Emeto, TI, Eshrati, B, Eslami, M, Esmaeili, Z, Fabin, N, Fagbamigbe, AF, Fagbule, OF, Falzone, L, Fareed, M, Farinha, CSES, Faris, MEM, Faro, A, Fasihi, K, Fatehizadeh, A, Fauk, NK, Fazylov, T, Feigin, VL, Fekadu, G, Feng, X, Fereshtehnejad, S-M, Ferrara, P, Ferreira, N, Firew, BS, Fischer, F, Fitriana, I, Flavel, J, Flor, LS, Folayan, MO, Foley, KM, Fonzo, M, Force, LM, Foschi, M, Freitas, A, Fridayani, NKY, Fukutaki, KG, Furtado, JM, Fux, B, Gaal, PA, Gadanya, MA, Gallus, S, Ganesan, B, Ganiyani, MA, Gautam, RK, Gebi, TG, Gebregergis, MW, Gebrehiwot, M, Getacher, L, Getahun, GKA, Gething, PW, Ghadimi, DJ, Ghadirian, F, Ghafarian, S, Ghailan, KY, Ghasemi, M, Dabaghi, GG, Ghazy, RM, Ghoba, S, Gholami, E, Gholamrezanezhad, A, Gholizadeh, N, Ghorbani, M, Vajargah, PG, Ghotbi, E, Gil, AU, Gill, TK, Girmay, A, Glasbey, JC, Glushkova, EV, Gnedovskaya, EV, Gobolos, L, Goldust, M, Goleij, P, Golinelli, D, Gopalani, SV, Goulart, AC, Gouravani, M, Goyal, A, Grivna, M, Grosso, G, Guarducci, G, Gubari, MIM, Guicciardi, S, Guimaraes, RA, Gulati, S, Gulisashvili, D, Gunawardane, DA, Guo, C, Gupta, AK, Gupta, R, Gupta, S, Gupta, VK, Haakenstad, A, Hadi, NR, Haep, N, Hafiz, A, Haghmorad, D, Haile, D, Ali, AH, Ali, HA, Haj-Mirzaian, A, Halboub, ES, Haller, S, Halwani, R, Abdullah, KH, Hamdy, NM, Hamoudi, R, Hanifi, N, Hankey, GJ, Haq, ZA, Haque, MR, Harapan, H, Hargono, A, Haro, JM, Hasaballah, AI, Hasan, SMM, Hasanian, M, Hasnain, MS, Hassan, A, Haubold, J, Hay, SI, Hebert, JJ, Hegazi, OE, Heidari, M, Hemmati, M, Henson, CA, Herrera-Serna, BY, Herteliu, C, Heydari, M, Hezam, K, Hidayana, I, Hiraike, Y, Hoan, NQ, Holla, R, Hoogar, P, Horita, N, Hossain, MM, Hosseinzadeh, H, Hosseinzadeh, M, Hostiuc, M, Hostiuc, S, Hu, C, Huang, J, Hultstrom, M, Hundie, TG, Hunt, AJ, Hushmandi, K, Hussain, J, Hussain, MA, Hussein, NR, Huynh, H-H, Hwang, B-F, Ibitoye, SE, Iftikhar, PM, Ikiroma, AI, Ikwegbue, PC, Ilic, IM, Ilic, MD, Immurana, M, Isa, MA, Islam, MR, Islam, SMS, Ismail, F, Ismail, NE, Isola, G, Iwagami, M, Iyamu, IO, Jacob, L, Jacobsen, KH, Jafarinia, M, Jahankhani, K, Jahanmehr, N, Jain, N, Jairoun, AA, Mani, DRJ, Jamil, S, Jamora, RDG, Jatau, AI, Javadov, S, Javaheri, T, Jayaram, S, Jee, SH, Jeganathan, J, Jiang, H, Jokar, M, Jonas, JB, Joseph, N, Joshua, CE, Jurisson, M, Vaishali, K, Kabir, A, Kabir, Z, Kadashetti, V, Kalankesh, LR, Kalra, S, Kamath, A, Kamath, R, Kamireddy, A, Kanaan, M, Kanchan, T, Kanmiki, EW, Kanmodi, KK, Kansal, SK, Karim, A, Karkhah, S, Kashoo, FZ, Kasraei, H, Kassel, MB, Katikireddi, SV, Kauppila, JH, Kaur, H, Kayode, GA, Kazemi, F, Kazemian, S, Kebede, F, Kendal, ES, Kesse-Guyot, E, Khademvatan, S, Khajuria, H, Khalaji, A, Khalid, A, Khalid, N, Khalilian, A, Khamesipour, F, Khan, F, Khan, MJ, Khan, MAB, Khanmohammadi, S, Khatab, K, Khatatbeh, H, Khatatbeh, MM, Khatib, MN, Kashani, HRK, Kheirallah, KA, Khokhar, M, Khormali, M, Khorrami, Z, Khosla, AA, Khosravi, M, Khosrowjerdi, M, Khubchandani, J, Kifle, ZD, Kim, G, Kim, JS, Kim, MS, Kim, YJ, Kimokoti, RW, Kisa, A, Kisa, S, Knibbs, LD, Knudsen, AKS, Kochhar, S, Kolahi, A-A, Kompani, F, Koren, G, Korzh, O, Krishan, K, Krishna, V, Krishnamoorthy, V, Bicer, BK, Kuddus, MA, Kuddus, M, Kuitunen, I, Kujan, O, Kulimbet, M, Kulkarni, V, Kumar, GA, Kumar, H, Kumar, N, Kumar, R, Kumar, V, Kundu, A, Kusuma, D, Kyei-Arthur, F, Kyto, V, Kyu, HH, La Vecchia, C, Lacey, B, Ladan, MA, Laflamme, L, Lahariya, C, Lai, DTC, Lalloo, R, Lallukka, T, Lam, J, Lan, Q, Lan, T, Landires, I, Lanfranchi, F, Langguth, B, Lansingh, VC, Laplante-Levesque, A, Larijani, B, Larsson, AO, Lasrado, S, Lauriola, P, Lawlor, HR, Le, H-H, Le, LKD, Le, NHH, Le, TTT, Le, TDT, Leasher, JL, Lee, DW, Lee, M, Lee, PH, Lee, S-W, Lee, SW, Lee, SWH, Lee, YH, Leigh, J, Leong, E, Li, M-C, Libra, M, Ligade, VS, Lim, L-L, Lim, SS, Limenh, LW, Lindholm, D, Lindstedt, PA, Listl, S, Liu, G, Liu, S, Liu, X, Llanaj, E, Lopez-Bueno, R, Lopez-Gil, JF, Loreche, AM, Lotufo, PA, Lozano, R, Lubinda, J, Lucchetti, G, Luo, L, Lusk, JB, Lv, L, Amin, HIM, Ma, ZF, Maass, KL, Machairas, N, Machoy, M, Madureira-Carvalho, AM, Abd El Razek, HM, Maghazachi, AA, Prasad, DRM, Mahalleh, M, Mahasha, PW, Mahmoud, MA, Mahmoudi, E, Mahmoudvand, G, Makama, M, Rad, EM, Malhotra, K, Malik, AA, Malta, DC, Manla, Y, Mansour, A, Mansouri, MH, Mansouri, P, Mansouri, V, Mansourian, M, Mansournia, MA, Marasini, BP, Marateb, HR, Maravilla, JC, Mardi, P, Marjani, A, Moghadam, HM, Arnedo, CAM, Martinez, G, Martinez-Piedra, R, Martins-Melo, FR, Martorell, M, Marx, W, Marzo, RR, Masoudi, S, Mathangasinghe, Y, Mathioudakis, AG, Mathur, M, Mathur, N, Matozinhos, FP, Mattumpuram, J, Maude, RJ, Maugeri, A, Mayeli, M, Mazidi, M, Mazzotti, A, McGrath, JJ, Mckee, M, McKowen, ALW, McPhail, MA, McPhail, SM, Mehmood, A, Mehrabani-Zeinabad, K, Mehravar, S, Meto, TM, Melese, EB, Mendez-Lopez, MAM, Mendoza, W, Menezes, RG, Mensah, GA, Mensah, LG, Mentis, A-FA, Meo, SA, Meretoja, A, Meretoja, TJ, Mersha, AM, Mestrovic, T, Mettananda, KCD, Mettananda, S, Mhlanga, A, Mhlanga, L, Miazgowski, T, Michalek, IM, de Sa, ACMGN, Miller, TR, Minh, LHN, Mirahmadi, A, Mirijello, A, Mirrakhimov, EM, Mirzaei, R, Mitchell, PB, Mittal, C, Moberg, ME, Fard, AM, Mohajelin, S, Mohamadkhani, A, Mohamed, AI, Mohamed, J, Mohamed, MFH, Mohamed, NS, Mohammad, AM, Mohammadi, S, Mohammed, H, Mohammed, M, Mohammed, S, Mokdad, AH, Molokhia, M, Momani, SM, Momtazmanesh, S, Monasta, L, Mondello, S, Moni, MA, Montazeri, F, Ghalibaf, AM, Moradi, M, Moradi, Y, Moraga, P, Morawska, L, Moreira, RS, Morovatdar, N, Morrison, SD, Mosapour, A, Mosser, JF, Mossialos, E, Motappa, R, Mougin, V, Mousavi, P, Mrejen, M, Mubarik, S, Mueller, UO, Mulita, F, Munjal, K, Murillo-Zamora, E, Musallam, KM, Musina, A-M, Mustafa, G, Myung, W, Nafei, A, Nagarajan, AJ, Naghavi, P, Naik, GR, Naik, G, Nainu, F, Najdaghi, S, Ansari, NN, Nangia, V, Swamy, SN, Nargus, S, Davani, DN, Nascimento, BR, Nascimento, GG, Naser, AY, Nashwan, AJ, Natto, ZS, Nauman, J, Navaratna, SNK, Naveed, M, Nawsherwan, Nayak, BP, Nayak, VC, Negash, H, Negoi, I, Negoi, RI, Nejadghaderi, SA, Nejjari, C, Nematollahi, S, Netsere, HB, Ng, M, Nguefack-Tsague, G, Ngunjiri, JW, Nguyen, AH, Nguyen, DH, Nguyen, HTH, Nguyen, N, Nguyen, NNY, Nguyen, PT, Nguyen, QP, Nguyen, VT, Minh, DNT, Niazi, RK, Nigatu, YT, Niknam, M, Nikoobar, A, Nikpoor, AR, Nikravangolsefid, N, Noman, EA, Nomura, S, Noor, STA, Noroozi, N, Nouri, M, Nozari, M, Nri-Ezedi, CA, Ntaios, G, Nunemo, MH, Nurrika, D, Nutor, JJ, Nzoputam, CI, Nzoputam, OJ, Oancea, B, Obamiro, KO, Odetokun, IA, Oduro, MS, Ogundijo, OA, Ogunfowokan, AA, Ogunkoya, A, Oguntade, AS, Oh, I-H, Ojo-Akosile, TR, Okati-Aliabad, H, Okekunle, AP, Okonji, OC, Olagunju, AT, Olatubi, MI, Oliveira, GMM, Olusanya, BO, Olusanya, JO, Oluwafemi, YD, Omar, HA, Omer, GL, Ong, S, Onie, S, Onwujekwe, OE, Opejin, AO, Ordak, M, Orish, VN, Ortiz, A, Ortiz-Prado, E, Osman, WMS, Ostojic, SM, Ostroff, SM, Osuagwu, UL, Otoiu, A, Otstavnov, SS, Ouyahia, A, Owolabi, MO, Oyeyemi, OT, Ozair, A, Padukudru, MPA, Padron-Monedero, A, Padubidri, JR, Pal, PK, Palicz, T, Pan, F, Pan, H-F, Panda-Jonas, S, Pandey, A, Pando-Robles, V, Pangaribuan, HU, Panos, GD, Panos, LD, Pantazopoulos, I, Stoian, AMP, Parikh, RR, Park, E-K, Park, S, Parsons, N, Parthasarathi, A, Pasovic, M, Passera, R, Patel, J, Pathan, AR, Patil, S, Patoulias, D, Pawar, S, Toroudi, HP, Pease, SA, Peden, AE, Pedersini, P, Pensato, U, Pepito, VCF, Peprah, P, Pereira, M, Pereira, MO, Perianayagam, A, Perico, N, Perna, S, Pesudovs, K, Petermann-Rocha, FE, Pham, HT, Philip, AK, Phillips, MR, Pigeolet, M, Piradov, MA, Pisoni, E, Plotnikov, E, Poddighe, D, Polibin, RV, Poluru, R, Ponkilainen, VT, Popovic, DS, Postma, MJ, Pour-Rashidi, A, Prabhu, D, Prada, SI, Pradhan, J, Pradhan, PMS, Prashant, A, Prates, EJS, Priscilla, T, Purnobasuki, H, Purohit, BM, Puvvula, J, Qasim, NH, Qattea, I, Qazi, AS, Qian, G, Rad, MR, Radhakrishnan, V, Shahraki, HR, Rafferty, Q, Raggi, A, Raggi, C, Raheem, N, Rahim, F, Rahim, MJ, Rahimibarghani, S, Rahman, MMMR, Rahman, M, Rahman, MA, Rahman, T, Rahmani, AM, Rahmanian, M, Rahmanian, N, Rahmati, R, Rahmawaty, S, Raimondo, D, Raja, A, Rajput, P, Ramadan, M, Ramasamy, SK, Ramazanu, 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Abstract: BACKGROUND: Future trends in disease burden and drivers of health are of great interest to policy makers and the public at large. This information can be used for policy and long-term health investment, planning, and prioritisation. We have expanded and improved upon previous forecasts produced as part of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) and provide a reference forecast (the most likely future), and alternative scenarios assessing disease burden trajectories if selected sets of risk factors were eliminated from current levels by 2050. METHODS: Using forecasts of major drivers of health such as the Socio-demographic Index (SDI; a composite measure of lag-distributed income per capita, mean years of education, and total fertility under 25 years of age) and the full set of risk factor exposures captured by GBD, we provide cause-specific forecasts of mortality, years of life lost (YLLs), years lived with disability (YLDs), and disability-adjusted life-years (DALYs) by age and sex from 2022 to 2050 for 204 countries and territories, 21 GBD regions, seven super-regions, and the world. All analyses were done at the cause-specific level so that only risk factors deemed causal by the GBD comparative risk assessment influenced future trajectories of mortality for each disease. Cause-specific mortality was modelled using mixed-effects models with SDI and time as the main covariates, and the combined impact of causal risk factors as an offset in the model. At the all-cause mortality level, we captured unexplained variation by modelling residuals with an autoregressive integrated moving average model with drift attenuation. These all-cause forecasts constrained the cause-specific forecasts at successively deeper levels of the GBD cause hierarchy using cascading mortality models, thus ensuring a robust estimate of cause-specific mortality. For non-fatal measures (eg, low back pain), incidence and prevalence were forecasted from mixed-effects m
Published: 2024

3. Global burden of 288 causes of death and life expectancy decomposition in 204 countries and territories and 811 subnational locations, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021

Author: Naghavi, M, Ong, KL, Aali, A, Ababneh, HS, Abate, YH, Abbafati, C, Abbasgholizadeh, R, Abbasian, M, Abbasi-Kangevari, M, Abbastabar, H, Abd ElHafeez, S, Abdelmasseh, M, Abd-Elsalam, S, Abdelwahab, A, Abdollahi, M, Abdollahifar, M-A, Abdoun, M, Abdulah, DM, Abdullahi, A, Abebe, M, Abebe, SS, Abedi, A, Abegaz, KH, Abhilash, ES, Abidi, H, Abiodun, O, Aboagye, RG, Abolhassani, H, Abolmaali, M, Abouzid, M, Aboye, GB, Abreu, LG, Abrha, WA, Abtahi, D, Abu Rumeileh, S, Abualruz, H, Abubakar, B, Abu-Gharbieh, E, Abu-Rmeileh, NME, Aburuz, S, Abu-Zaid, A, Accrombessi, MMK, Adal, TG, Adamu, AA, Addo, IY, Addolorato, G, Adebiyi, AO, Adekanmbi, V, Adepoju, AV, Adetunji, CO, Adetunji, JB, Adeyeoluwa, TE, Adeyinka, DA, Adeyomoye, OI, Admass, BAA, Adnani, QES, Adra, S, Afolabi, AA, Afzal, MS, Afzal, S, Agampodi, SB, Agasthi, P, Aggarwal, M, Aghamiri, S, Agide, FD, Agodi, A, Agrawal, A, Agyemang-Duah, W, Ahinkorah, BO, Ahmad, A, Ahmad, D, Ahmad, F, Ahmad, MM, Ahmad, S, Ahmad, T, Ahmadi, K, Ahmadzade, AM, Ahmed, A, Ahmed, H, Ahmed, LA, Ahmed, MS, Ahmed, MB, Ahmed, SA, Ajami, M, Aji, B, Akara, EM, Akbarialiabad, H, Akinosoglou, K, Akinyemiju, T, Akkaif, MA, Akyirem, S, Al Hamad, H, Al Hasan, SM, Alahdab, F, Alalalmeh, SO, Alalwan, TA, Al-Aly, Z, Alam, K, Alam, M, Alam, N, Al-amer, RM, Alanezi, FM, Alanzi, TM, Al-Azzam, S, Albakri, A, Albashtawy, M, AlBataineh, MT, Alcalde-Rabanal, JE, Aldawsari, KA, Aldhaleei, WA, Aldridge, RW, Alema, HB, Alemayohu, MA, Alemi, S, Alemu, YM, Al-Gheethi, AAS, Alhabib, KF, Alhalaiqa, FAN, Al-Hanawi, MK, Ali, A, Ali, L, Ali, MU, Ali, R, Ali, S, Ali, SSS, Alicandro, G, Alif, SM, Alikhani, R, Alimohamadi, Y, Aliyi, AA, Aljasir, MAM, Aljunid, SM, Alla, F, Allebeck, P, Al-Marwani, S, Al-Maweri, SAA, Almazan, JU, Al-Mekhlafi, HM, Almidani, L, Almidani, O, Alomari, MA, Al-Omari, B, Alonso, J, Alqahtani, JS, Alqalyoobi, S, Alqutaibi, AY, Al-Sabah, SK, Altaany, Z, Altaf, A, Al-Tawfiq, JA, Altirkawi, KA, Aluh, DO, Alvis-Guzman, N, Alwafi, H, Al-Worafi, 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Wang, S, Wang, Y, Wang, Y-P, Waqas, M, Ward, P, Wassie, EG, Watson, S, Watson, SLW, Weerakoon, KG, Wei, MY, Weintraub, RG, Weiss, DJ, Westerman, R, Whisnant, JL, Wiangkham, T, Wickramasinghe, DP, Wickramasinghe, ND, Wilandika, A, Wilkerson, C, Willeit, P, Wilson, S, Wojewodzic, MW, Woldegebreal, DH, Wolf, AW, Wolfe, CDA, Wondimagegene, YA, Wong, YJ, Wongsin, U, Wu, A-M, Wu, C, Wu, F, Wu, X, Wu, Z, Xia, J, Xiao, H, Xie, Y, Xu, S, Xu, W-D, Xu, X, Xu, YY, Yadollahpour, A, Yamagishi, K, Yang, D, Yang, L, Yano, Y, Yao, Y, Yaribeygi, H, Ye, P, Yehualashet, SS, Yesiltepe, M, Yesuf, SA, Yezli, S, Yi, S, Yigezu, A, Yiğit, A, Yiğit, V, Yip, P, Yismaw, MB, Yismaw, Y, Yon, DK, Yonemoto, N, Yoon, S-J, You, Y, Younis, MZ, Yousefi, Z, Yu, C, Yu, Y, Yuh, FH, Zadey, S, Zadnik, V, Zafari, N, Zakham, F, Zaki, N, Zaman, SB, Zamora, N, Zand, R, Zangiabadian, M, Zar, HJ, Zare, I, Zarrintan, A, Zeariya, MGM, Zeinali, Z, Zhang, H, Zhang, J, Zhang, L, Zhang, Y, Zhang, Z-J, Zhao, H, Zhong, C, Zhou, J, Zhu, B, Zhu, L, Ziafati, M, Zielińska, M, Zitoun, OA, Zoladl, M, Zou, Z, Zuhlke, LJ, Zumla, A, Zweck, E, Zyoud, SH, Wool, EE, and Murray, CJL
Published: 2024

4. IMPROVEMENTS IN FATIGUE AND 6-MINUTE WALK TEST IN ADULTS WITH ALPHA- OR BETA-NON–TRANSFUSION-DEPENDENT THALASSEMIA: THE PHASE 3 ENERGIZE TRIAL OF MITAPIVAT

Author: Kuo, KH, Al-Samkari, H, Aydinok, Y, Besser, M, Gheuens, S, Luna, G, Glenthj, A, Goh, AS, Kattamis, A, Loggetto, SR, Musallam, KM, Ricchi, P, Salido-Fiérrez, E, Sheth, S, Viprakasit, V, Cappellini, MD, and Taher, AT
Published: 2024
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5. ENERGIZE: A GLOBAL PHASE 3 STUDY OF MITAPIVAT DEMONSTRATING EFFICACY AND SAFETY IN ADULTS WITH ALPHA- OR BETA-NON–TRANSFUSION-DEPENDENT THALASSEMIA

Author: Taher, AT, Al-Samkari, H, Aydinok, Y, Besser, M, Luna, G, Gheuens, S, Glenthj, A, Goh, AS, Kattamis, A, Loggetto, SR, Musallam, KM, Ricchi, P, Salido-Fiérrez, E, Sheth, S, Viprakasit, V, Cappellini, MD, and Kuo, KH
Published: 2024
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6. Prevalence and risk factors for pulmonary arterial hypertension in a large group of β-thalassemia patients using right heart catheterization: a Webthal study

Author: Derchi G, Galanello R, Bina P, Cappellini MD, Piga A, Lai ME, Quarta A, Casu G, Pinto V, Musallam KM, Forni GL, Webthal Pulmonary Arterial Hypertension Group, PERROTTA, Silverio, Derchi, G, Galanello, R, Bina, P, Cappellini, Md, Piga, A, Lai, Me, Quarta, A, Casu, G, Perrotta, Silverio, Pinto, V, Musallam, Km, Forni, Gl, and Webthal Pulmonary Arterial Hypertension, Group
Published: 2014

7. Prevalence and Risk Factors for Pulmonary Arterial Hypertension in a Large Group of β-Thalassemia Patients Using Right Heart Catheterization: A Webthal(R) Study

Author: Derchi, G, Galanello, R, Bina, P, Cappellini, Md, Piga, Antonio Giulio, Lai, Me, Quarta, A, Casu, G, Perrotta, S, Pinto, V, Musallam, Km, Forni, Gl, and on behalf of the Webthal® Pulmonary Arterial Hypertension Group
Subjects: Adult, Male, Right heart catheterization, Cardiac Catheterization, medicine.medical_specialty, Hypertension, Pulmonary, Thalassemia, Pulmonary arterial pressure, Jet velocity, Predictive Value of Tests, Risk Factors, Physiology (medical), Internal medicine, Prevalence, medicine, Humans, Familial Primary Pulmonary Hypertension, In patient, Pulmonary Wedge Pressure, Pulmonary wedge pressure, business.industry, beta-Thalassemia, Middle Aged, medicine.disease, Confidence interval, Surgery, Cross-Sectional Studies, Logistic Models, Echocardiography, Case-Control Studies, Multivariate Analysis, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Large group
Abstract: Background— Pulmonary arterial hypertension (PAH) remains a concern in patients with β-thalassemia major (TM) and intermedia (TI); however, studies evaluating its prevalence and risk factors using systematic confirmation on right heart catheterization are lacking. Methods and Results— This was a multicenter cross-sectional study of 1309 Italian β-thalassemia patients (mean age 36.4±9.3 years; 46% men; 74.6% TM, 25.4% TI). Patients with a tricuspid-valve regurgitant jet velocity ≥3.2 m/s (3.6%) on transthoracic echocardiography further underwent right heart catheterization to confirm the diagnosis of PAH (mean pulmonary arterial pressure ≥25 mm Hg and pulmonary capillary wedge pressure ≤15mm Hg). The confirmed PAH prevalence on right heart catheterization was 2.1% (95% confidence interval [CI], 1.4–3.0) and was higher in TI (4.8%; 95% CI, 3.0–7.7) than TM (1.1%; 95% CI, 0.6–2.0). The positive predictive value for the tricuspid-valve regurgitant jet velocity ≥3.2 m/s threshold for the diagnosis of pulmonary hypertension was 93.9%. Considerable functional limitation and decrease in the 6-minute walk distance were noted in patients with confirmed PAH. On multivariate logistic regression analysis, independent risk factors for confirmed PAH were age (odds ratio, 1.102 per 1-year increase; 95% CI, 1.06–1.15) and splenectomy (odds ratio, 9.31; 95% CI, 2.57–33.7). Conclusions— The prevalence of PAH in β-thalassemia patients as confirmed on right heart catheterization was 2.1%, with an ≈5-fold higher prevalence in TI than TM. Advanced age and splenectomy are risk factors for PAH in this patient population. Clinical Trial Registration— URL: http://www.ClinicalTrials.gov . Unique identifier: NCT01496963.
Published: 2014

8. The effect of maternal fasting during Ramadan on preterm delivery: a prospective cohort study

Author: Awwad, J, primary, Usta, IM, additional, Succar, J, additional, Musallam, KM, additional, Ghazeeri, G, additional, and Nassar, AH, additional
Published: 2012
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9. Childhood stroke in a child with familial Mediterranean fever carrying several prothrombotic risk factors

Author: Aoun, EG, primary, Musallam, KM, additional, Uthman, I, additional, Beydoun, A, additional, El-Hajj, T, additional, and Taher, AT, additional
Published: 2009
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10. Serum ferritin levels and endocrinopathy in medically treated patients with [beta] thalassemia major.

Author: Belhoul KM, Bakir ML, Saned MS, Kadhim AM, Musallam KM, and Taher AT
Published: 2012

11. The Spine in [beta]-Thalassemia Syndromes.

Author: Haidar R, Mhaidli H, Musallam KM, and Taher AT
Published: 2012
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12. Brain positron emission tomography in splenectomized adults with [beta]-thalassemia intermedia: uncovering yet another covert abnormality.

Author: Musallam KM, Nasreddine W, Beydoun A, Hourani R, Hankir A, Koussa S, Haidar M, and Taher AT
Published: 2012

13. Primary colorectal lymphoma.

Author: Musallam KM, Hatoum HA, Barada K, Taher AT, Salem ME, Malek EM, Shamseddine AI, Musallam, Khaled M, Hatoum, Hasan A, Barada, Kassem, Taher, Ali T, Salem, Mohamed E, Malek, Eliane M, and Shamseddine, Ali I
Abstract: This study aimed at investigating the incidence, presentation, patient and tumor characteristics, treatment, and outcome of primary colorectal lymphomas (PCL) at a tertiary care center in Lebanon over a 25-year period. The Dawson's criteria were used for selection of eligible cases. The medical records were reviewed for demographic variables, the presence of risk factors, presenting signs and symptoms, method of diagnosis, histologic type, type of therapy, and condition at last follow-up. Nine cases of PCL were identified (12.7% of gastrointestinal lymphomas and 0.1% of colorectal malignancies). The mean age at presentation was 44.2 years with male predominance noted. Abdominal pain was the most common presentation (77.8%). Colonoscopy was performed for eight patients with non-specific gross tumor characteristics. Three patients had Burkitt's and six had diffuse large B-Cell lymphomas. The most common site of involvement was the cecum (55.6%) with all cases presenting in stage I(E). Surgery was performed for six patients followed by chemotherapy except for one, and three patients had chemotherapy only. The median survival time was 25 months and the 2-year survival time was approximated at 60%. It is concluded that PCL is a rare malignancy with well-identified disease characteristics yet controversial ideal management plan. [ABSTRACT FROM AUTHOR]
Published: 2010
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14. Clinicovirologic analysis of hepatitis C infection in transfusion-dependent ß-thalassemia major children.

Author: Ragab L, Helal S, Zaghloul N, El-Raziky M, Afifi R, Musallam KM, and Taher AT
Published: 2010
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15. Abdominal manifestations of multiple myeloma: a retrospective radiologic overview.

Author: Birjawi GA, Jalbout R, Musallam KM, Tawil AN, Taher AT, and Khoury NJ
Published: 2008

16. Iron-chelating therapy for transfusional iron overload.

Author: Musallam KM, Taher AT, Musallam, Khaled M, and Taher, Ali T
Published: 2011
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17. Small bowel intussusception following blunt abdominal trauma in an adult patient.

Author: Karam J, Khreiss M, Musallam KM, Alaeddine MH, Al-Kutoubi A, Abi Saad GS, Karam, J, Khreiss, M, Musallam, K M, Alaeddine, M H, Al-Kutoubi, A, and Abi Saad, G S
Abstract: Blunt abdominal trauma is a rare cause of small bowel intussusception in adults. A patient is described who presented with signs and symptoms of intestinal obstruction following a fall from a ladder. A CT scan revealed evidence of ileo-ileal intussusception. Exploratory laparotomy and resection of a necrotic bowel segment were performed. Rare occurrences like intussusception should be kept in mind in similar presentations with careful examination of the pathognomonic CT findings, as early detection and surgical intervention with manual reduction could preclude the need for small bowel resection and its untoward possible complications. [ABSTRACT FROM AUTHOR]
Published: 2009
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18. The wanderer At 12 weeks' gestation, the patient presented with abdominal pain and a palpable mass.

Author: Ghazeeri G, Nassar AH, Taher AT, Musallam KM, and Jamali FR
Published: 2010
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19. The role of liver iron in hepatitis C antiviral treatment.

Author: Musallam KM, Sharara AI, Inati A, Taher AT, Musallam, Khaled M, Sharara, Ala I, Inati, Adlete, and Taher, Ali T
Published: 2010
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20. Clinical images: Severe photosensitive skin reaction secondary to an herbal treatment in a patient with systemic lupus erythematosus.

Author: Musallam KM, Baydoun EA, and Uthman I
Published: 2009
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21. Tricuspid-valve regurgitant jet velocity as a risk factor for death in β-thalassemia

Author: Giorgio Derchi, Khaled M. Musallam, Valeria Maria Pinto, Giovanna Graziadei, Marianna Giuditta, Susanna Barella, Raffaella Origa, Gavino Casu, Annamaria Pasanisi, Filomena Longo, Maddalena Casale, Roberta Miceli, Pierluigi Merella, Barbara Gianesin, Pietro Ameri, Immacolata Tartaglione, Silverio Perrotta, Antonio Piga, Maria Domenica Cappellini, Gian Luca Forni, Derchi, G, Musallam, Km, Pinto, Vm, Graziadei, G, Giuditta, M, Barella, S, Origa, R, Casu, G, Pasanisi, A, Longo, F, Casale, M, Miceli, R, Merella, P, Gianesin, B, Ameri, P, Tartaglione, I, Perrotta, S, Piga, A, Cappellini, Md, and Forni, Gl
Subjects: Risk Factors, beta-Thalassemia, Humans, Hematology, Blood Flow Velocity, Tricuspid Valve Insufficiency
Published: 2022

22. Implementation of an emergency department computer system: design features that users value.

Author: Batley NJ, Osman HO, Kazzi AA, and Musallam KM
Published: 2011

23. Long-term improvement in cardiac magnetic resonance in β-thalassemia major patients treated with deferasirox extends to patients with abnormal baseline cardiac function

Author: Alfonso Ragozzino, Giuseppe Signoriello, Saverio Scianguetta, Umberto Pugliese, Silverio Perrotta, Giuliana Rispoli, Domenico Roberti, Giovanni Amendola, Aldo Filosa, Khaled M. Musallam, Domenico Cozzolino, Immacolata Tartaglione, Elisa De Michele, Francesco Palmieri, Maddalena Casale, Casale, M, Filosa, Antonio, Ragozzino, A, Amendola, G, Roberti, D, Tartaglione, I, De Michele, E, Cozzolino, D, Rispoli, G, Palmieri, F, Pugliese, U, Scianguetta, S, Signoriello, G, Musallam, Km, and Perrotta, S
Subjects: Male, Cardiac function curve, medicine.medical_specialty, Iron Overload, Thalassemia, Population, 030204 cardiovascular system & hematology, Iron Chelating Agents, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Humans, Medicine, Blood Transfusion, Child, education, Retrospective Studies, education.field_of_study, Ejection fraction, medicine.diagnostic_test, business.industry, beta-Thalassemia, Deferasirox, Disease Management, Infant, Arrhythmias, Cardiac, Stroke Volume, Magnetic resonance imaging, Hematology, medicine.disease, Magnetic Resonance Imaging, Discontinuation, Treatment Outcome, Child, Preschool, Heart failure, cardiovascular system, Cardiology, Female, business, 030215 immunology, medicine.drug
Abstract: The management of iron overload in thalassemia has changed dramatically since the implementation of magnetic resonance imaging, which allows detection of preclinical iron overload and prevention of clinical complications. This study evaluated the effect of deferasirox (DFX), the newest once-daily oral chelator, on cardiac function, iron overload and cardiovascular events over a longer follow up in a "real world" setting. Longitudinal changes in cardiac magnetic resonance T2*, cardiac function parameters and cardiovascular clinical events were assessed in a cohort of 98 TM patients exposed to DFX for a mean of 6.9 years (range 1.8-11.6 years). No cardiac death or incident heart failure occurred. Cardiac T2* significantly increased (+2.6 ± 11.9 msec; P = 0.035) in the whole population, with a significantly greater increase (+11.6 ± 15.5 msec, P = 0.019) in patients with cardiac iron overload (T2*20 ms). A significant improvement in left-ventricular ejection fraction (LVEF) (from 50.6 ± 6 to 60.2 ± 5; P = 0.001) was observed in 11 (84.6%) out of 13 patients who normalized cardiac function (LVEF56%). Arrhythmias were the most frequent cardiac adverse event noted but none led to DFX discontinuation. Our data indicate that DFX is effective in maintaining cardiac iron level in the normal range and in improving cardiac iron overload. No heart failure or cardiac death was reported over this longer observation up to 12 years. For the first time, a DFX-induced improvement in LVEF was observed in a subgroup of patients with abnormal cardiac function at baseline, a preliminary observation which deserves further evaluation.
Published: 2019

24. Identifying thresholds for meaningful improvements in NTDT-PRO scores to support conclusions about treatment benefit in clinical studies of patients with non-transfusion-dependent beta-thalassaemia: analysis of pooled data from a phase 2, double-blind, placebo-controlled, randomised trial.

Author: Taher AT, Musallam KM, Viprakasit V, Kattamis A, Lord-Bessen J, Yucel A, Guo S, Pelligra CG, Shields AL, Shetty JK, Glassberg MB, Bueno LM, and Cappellini MD
Subjects: Humans, Female, Male, Double-Blind Method, Adult, Middle Aged, Fatigue, Severity of Illness Index, Dyspnea therapy, Treatment Outcome, beta-Thalassemia therapy, Patient Reported Outcome Measures
Abstract: Objectives: To estimate thresholds for defining meaningful within-patient improvement from baseline to weeks 13-24 and interpreting meaningfulness of between-group difference for the non-transfusion-dependent beta-thalassaemia patient-reported outcome (NTDT-PRO) tiredness/weakness (T/W) and shortness of breath (SoB) scores. A secondary objective was to determine the symptom severity threshold for the NTDT-PRO T/W domain to identify patients with symptomatic T/W., Design: Pooled blinded data from the phase 2, double-blind, placebo-controlled, randomised BEYOND trial in NTDT (NCT03342404) were used. Anchor-based analyses supplemented with distribution-based analyses and empirical cumulative distribution function (eCDF) curves were applied. Distribution-based analyses and receiver operating characteristic curves were used to estimate between-group difference and symptomatic thresholds, respectively., Setting: Greece, Italy, Lebanon, Thailand, the UK and the USA., Participants: Adults (N=145; mean age 39.9 years) with NTDT who were transfusion-free ≥8 weeks before randomisation., Measures: Score changes from baseline to weeks 13-24 in PROs used as anchors (correlation coefficient ≥0.3): NTDT-PRO T/W and SoB scores, Patient Global Impression of Severity, Functional Assessment of Chronic Illness Therapy-Fatigue (Fatigue Subscale, item HI12 and item An2) and Short Form Health Survey version 2., Results: The eCDF curves support the use of estimates from the improvement by one level group for all anchors to determine the threshold(s) for meaningful within-patient improvement. Mean (median) changes from these groups and estimates from distribution-based analyses suggest that a ≥1-point reduction in the NTDT-PRO T/W or SoB domains represents a clinically meaningful improvement. Meaningful between-group difference threshold ranges were 0.53-1.10 for the T/W domain and 0.65-1.15 for the SoB domain. The optimal symptomatic threshold for the T/W domain (by maximum Youden's index) was ≥3 points., Conclusions: The thresholds proposed may support the use of NTDT-PRO in assessing and interpreting treatment effects in clinical studies and identifying patients with NTDT in need of symptom relief., Competing Interests: Competing interests: ATT has received consulting fees and research funding from Agios Pharmaceuticals, Celgene/Bristol Myers Squibb, Ionis Pharmaceuticals, Novartis Pharmaceuticals and Vifor Pharma. KMM has received consulting fees from Agios Pharmaceuticals, Celgene/Bristol Myers Squibb, CRISPR Therapeutics, Novartis, Pharmacosmos and Vifor Pharma; research funding from Agios Pharmaceuticals and Pharmacosmos. VV has received research funding from Bristol Myers Squibb. AK has received advisory board fees and consulting fees from Agios Pharmaceuticals, Celgene/Bristol Myers Squibb, Chiesi Farmaceutici, CRISPR Therapeutics/Vertex Pharmaceuticals, Ionis Pharmaceuticals, Novartis and Vifor Pharma; research support from Celgene/Bristol Myers Squibb and Novartis. JL-B, AY, MBG and LMB are employed by and are stock/equity holders of Bristol Myers Squibb. SG is employed by Evidera; has received consultancy fees from Bristol Myers Squibb, Gilead and Janssen. CGP is employed by Evidera. ALS is employed by Adelphi Values. JKS was formerly employed by and is currently a stock/equity holder of Bristol Myers Squibb. MDC has received advisory board fees from Celgene/Bristol Myers Squibb, CRISPR Therapeutics, Ionis Pharmaceuticals, Novartis, Novo Nordisk, Sanofi Genzyme and Vifor Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2024
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25. Trans-acting genetic modifiers of clinical severity in heterozygous β-Thalassemia trait.

Author: Loh JB, Ross JM, Musallam KM, and Kuo KHM
Subjects: Humans, beta-Globins genetics, Severity of Illness Index, Genes, Modifier, alpha-Globins genetics, Ion Channels genetics, beta-Thalassemia genetics, Heterozygote, Mutation
Abstract: There is a group of beta (β)-thalassemia trait 'carriers' (with heterozygous mutations) who should be asymptomatic with minor abnormalities in their hematological parameters, but experience more severe disease manifestations than predicted based solely on their β-globin genotype. This review focuses on literature describing trans-acting genetic modifiers outside of the α- and β-globin gene clusters that could cause this phenomenon. These genetic modifiers are categorized into: mutations affecting the quantity of alpha-globin products, non-globin mutations affecting erythropoiesis, membranopathies, enzymopathies and erythrocyte-independent modifiers of complications relating to β-thalassemia. Although some genetic determinants seem to correlate more directly with β-thalassemia trait severity, such as mutations in SUPT5H, PIEZO1 and hereditary elliptocytosis, the difficulties of linking the contribution of other modulating factors are elucidated in this review. Targeted next generation sequencing of hemolytic anemias can be helpful but also raises another quandary in interpreting variants of uncertain significance. The accrual of knowledge, along with the increased availability of genetic testing for genetic modifiers has considerable potential for clinical applications such as genetic counselling, decision-making for clinical interventions and prognostication, and perhaps generating new therapeutic targets., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Published: 2024
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26. Anemia and iron overload as prognostic markers of outcomes in β-thalassemia.

Author: Musallam KM, Sheth S, Cappellini MD, Forni GL, Maggio A, and Taher AT
Subjects: Humans, Prognosis, Blood Transfusion, beta-Thalassemia complications, beta-Thalassemia therapy, beta-Thalassemia diagnosis, beta-Thalassemia mortality, beta-Thalassemia blood, Iron Overload etiology, Iron Overload diagnosis, Biomarkers, Anemia etiology, Anemia diagnosis, Anemia therapy, Anemia blood
Abstract: Introduction: Ineffective erythropoiesis and subsequent anemia as well as primary and secondary (transfusional) iron overload are key drivers for morbidity and mortality outcomes in patients with β-thalassemia., Areas Covered: In this review, we highlight evidence from observational studies evaluating the association between measures of anemia and iron overload versus outcomes in both non-transfusion-dependent and transfusion-dependent forms of β-thalassemia., Expert Opinion: Several prognostic thresholds have been identified with implications for patient management. These have also formed the basis for the design of novel therapy clinical trials by informing eligibility and target endpoints. Still, several data gaps persist in view of the challenge of assessing prospective long-term outcomes in a chronic disease. Pooling insights on the prognostic value of different measures of disease mechanism will be key to design future scoring systems that can help optimize patient management.
Published: 2024
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27. Revisiting iron overload status and change thresholds as predictors of mortality in transfusion-dependent β-thalassemia: a 10-year cohort study.

Author: Musallam KM, Barella S, Origa R, Ferrero GB, Lisi R, Pasanisi A, Longo F, Gianesin B, and Forni GL
Subjects: Humans, Female, Male, Adult, Retrospective Studies, Adolescent, Ferritins blood, Young Adult, Middle Aged, Iron blood, Iron metabolism, Cohort Studies, Child, Follow-Up Studies, Italy epidemiology, Iron Overload mortality, Iron Overload blood, Iron Overload etiology, beta-Thalassemia therapy, beta-Thalassemia mortality, beta-Thalassemia blood, beta-Thalassemia complications, Blood Transfusion
Abstract: Data on iron overload status and change thresholds that can predict mortality in patients with transfusion-dependent β-thalassemia (TDT) are limited. This was a retrospective cohort study of 912 TDT patients followed for up to 10 years at treatment centers in Italy (median age 32 years, 51.6% female). The crude mortality rate was 2.9%. Following best-predictive threshold identification through receiver operating characteristic curve analyses, data from multivariate Cox-regression models showed that patients with Period Average Serum Ferritin (SF) > 2145 vs ≤ 2145 ng/mL were 7.1-fold (P < 0.001) or with Absolute Change SF > 1330 vs ≤ 1330 ng/mL increase were 21.5-fold (P < 0.001) more likely to die from any cause. Patients with Period Average Liver Iron Concentration (LIC) > 8 vs ≤ 8 mg/g were 20.2-fold (P < 0.001) or with Absolute Change LIC > 1.4 vs ≤ 1.4 mg/g increase were 27.6-fold (P < 0.001) more likely to die from any cause. Patients with Index (first) cardiac T2* (cT2*) < 27 vs ≥ 27 ms were 8.6-fold (P < 0.001) more likely to die from any cause. Similarly, results at varying thresholds were identified for death from cardiovascular disease. These findings should support decisions on iron chelation therapy by establishing treatment targets, including safe iron levels and clinically meaningful changes over time., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Published: 2024
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28. Differential effects of iron chelators on iron burden and long-term morbidity and mortality outcomes in a large cohort of transfusion-dependent β-thalassemia patients who remained on the same monotherapy over 10 years.

Author: Musallam KM, Barella S, Origa R, Ferrero GB, Lisi R, Pasanisi A, Longo F, Gianesin B, and Forni GL
Subjects: Humans, Female, Male, Adult, Retrospective Studies, Iron Overload etiology, Iron Overload drug therapy, Benzoates therapeutic use, Ferritins blood, Adolescent, Triazoles therapeutic use, Young Adult, Child, Treatment Outcome, Middle Aged, Liver metabolism, Liver drug effects, Liver pathology, Cohort Studies, Iron Chelating Agents therapeutic use, beta-Thalassemia mortality, beta-Thalassemia therapy, beta-Thalassemia drug therapy, beta-Thalassemia complications, Deferoxamine therapeutic use, Deferiprone therapeutic use, Iron metabolism, Deferasirox therapeutic use, Pyridones therapeutic use, Blood Transfusion
Abstract: We conducted a retrospective cohort study on 663 transfusion-dependent β-thalassemia patients receiving the same iron chelation monotherapy with deferoxamine, deferiprone, or deferasirox for up to 10 years (median age 31.8 years, 49.9 % females). Patients on all three iron chelators had a steady and significant decline in serum ferritin over the 10 years (median deferoxamine: -170.7 ng/mL, P = 0.049, deferiprone: -236.7 ng/mL, P = 0.001; deferasirox: -323.7 ng/mL, P < 0.001) yet had no significant change in liver iron concentration or cardiac T2*; while noting that patients generally had low hepatic and cardiac iron levels at study start. Median absolute, relative, and normalized changes were generally comparable between the three iron chelators. Patients receiving deferasirox had the highest morbidity and mortality-free survival probability among the three chelators, although the difference was only statistically significant when compared with deferoxamine (P = 0.037). On multivariate Cox regression analysis, there was no significant association between iron chelator type and the composite outcome of morbidity or mortality. In a real-world setting, there is comparable long-term iron chelation effectiveness between the three available iron chelators for patients with mild-to-moderate iron overload., Competing Interests: Declaration of competing interest KMM reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, CRISPR Therapeutics, Vifor Pharma, and Pharmacosmos; and research funding from Agios Pharmaceuticals and Pharmacosmos. SB reports being on the advisory board of Vertex Pharmaceuticals and Bristol Myers Squibb and receiving speaker honoraria from Bristol Myers Squibb and Chiesi. RO reports being on the advisory board of Chiesi and Bristol Myers Squibb and consultancy fees from Vertex Pharmaceuticals and Bristol Myers Squibb. GBF reports consultancy fees from Bristol Myers Squibb, Agios Pharmaceuticals, FORMA Therapeutics, Vertex Pharmaceuticals. RL reports receiving speaker honoraria from Bristol Myers Squibb. AP reports receiving speaker honoraria from Bristol Myers Squibb. FL reports being on the advisory board of Vertex Pharmaceuticals and Bristol Myers Squibb. GLF reports receiving speaker honoraria and being on the advisory board Vertex Pharmaceuticals, Bristol Myers Squibb, Hemanext and Garuda Pharmaceuticals. The remaining authors have no relevant financial or non-financial interests to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)
Published: 2024
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29. Quality of life, mood disorders, and cognitive impairment in adults with β-thalassemia.

Author: Bizri M, Koleilat R, Akiki N, Dergham R, Mihailescu AM, Bou-Fakhredin R, Musallam KM, and Taher AT
Subjects: Adult, Humans, Mood Disorders etiology, Quality of Life psychology, beta-Thalassemia complications, beta-Thalassemia therapy, Cognitive Dysfunction etiology
Abstract: Advances in understanding the disease process in β-thalassemia supported development of various treatment strategies that resulted in improved survival. Improved survival, however, allowed multiple morbidities to manifest and cemented the need for frequent, lifelong treatment. This has directly impacted patients' health-related quality of life and opened the door for various psychiatric and cognitive disorders to potentially develop. In this review, we summarize available evidence on quality of life, depression and anxiety, suicidality, and cognitive impairment in adult patients with β-thalassemia while sharing our personal insights from experience in treating patients with both transfusion-dependent and non-transfusion-dependent forms., Competing Interests: Declaration of competing interest K.M.M. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, CRISPR Therapeutics, Vifor Pharma, and Pharmacosmos; and research funding from Agios Pharmaceuticals and Pharmacosmos. A.T.T. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Vifor Pharma, and Pharmacosmos; and research funding from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Vifor Pharma, and Pharmacosmos. The remaining authors have no relevant financial or non-financial interests to disclose., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
Published: 2024
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30. Not only a Western world issue: Cancer incidence in younger individuals in the United Arab Emirates.

Author: Al-Shamsi HO and Musallam KM
Subjects: Humans, United Arab Emirates epidemiology, Incidence, Adult, Female, Male, Adolescent, Middle Aged, Young Adult, Child, Age Factors, Neoplasms epidemiology
Published: 2024
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31. Systematic review and evidence gap assessment of the clinical, quality of life, and economic burden of alpha-thalassemia.

Author: Musallam KM, Viprakasit V, Lombard L, Gilroy K, Rane A, Vinals L, Tam C, Rizzo M, and Coates TD
Abstract: A recent evidence gaps assessment of the clinical, health-related quality of life, and economic burden associated with α-thalassemia is lacking. We conducted a systematic literature review (SLR) following the methodological and reporting requirements of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and the Cochrane Handbook for Systematic Reviews, using available literature over the past decade. This SLR identified a considerable evidence gap with regard to understanding the current burden of α-thalassemia as evident from paucity of studies published in the past 10 years. The limited data available still indicate that patients with α-thalassemia experience substantial morbidity and quality of life/economic burden that is generally comparable to patients with β-thalassemia., Competing Interests: Khaled M. Musallam has been or is a consultant for Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, CRISPR Therapeutics, Vifor Pharma, and Pharmacosmos; and received research funding from Agios Pharmaceuticals and Pharmacosmos. Vip Viprakasit is supported by the Department of Research Development, Faculty of Medicine Siriraj Hospital. He received research grants from Agios, GPO (Thailand), Bristol Myers Squibb and Silence for clinical research studies. Louise Lombard, Keely Gilroy, and Amey Rane are employees of and own stock in Agios Pharmaceuticals. Thomas D. Coates provides advisory support to Agios Pharmaceuticals, Bristol Myers Squibb, and Chiesi. Lydia Vinals and Maria Rizzo are employees of Cytel Inc. Candice Tam was employed by Cytel Inc during the conduct of this work., (© 2024 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.)
Published: 2024
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32. Pretransfusion hemoglobin level and mortality in adults with transfusion-dependent β-thalassemia.

Author: Musallam KM, Barella S, Origa R, Ferrero GB, Lisi R, Pasanisi A, Longo F, Gianesin B, and Forni GL
Subjects: Adult, Humans, Hemoglobins analysis, Blood Transfusion, beta-Thalassemia therapy
Published: 2024
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33. Αlpha-thalassemia: A practical overview.

Author: Musallam KM, Cappellini MD, Coates TD, Kuo KHM, Al-Samkari H, Sheth S, Viprakasit V, and Taher AT
Subjects: Humans, Erythropoiesis, Erythrocyte Transfusion, beta-Thalassemia therapy, alpha-Thalassemia diagnosis, alpha-Thalassemia genetics, alpha-Thalassemia therapy, Hematologic Diseases, Iron Overload diagnosis, Iron Overload etiology, Iron Overload therapy
Abstract: α-Thalassemia is an inherited blood disorder characterized by decreased synthesis of α-globin chains that results in an imbalance of α and β globin and thus varying degrees of ineffective erythropoiesis, decreased red blood cell (RBC) survival, chronic hemolytic anemia, and subsequent comorbidities. Clinical presentation varies depending on the genotype, ranging from a silent or mild carrier state to severe, transfusion-dependent or lethal disease. Management of patients with α-thalassemia is primarily supportive, addressing either symptoms (eg, RBC transfusions for anemia), complications of the disease, or its transfusion-dependence (eg, chelation therapy for iron overload). Several novel therapies are also in development, including curative gene manipulation techniques and disease modifying agents that target ineffective erythropoiesis and chronic hemolytic anemia. This review of α-thalassemia and its various manifestations provides practical information for clinicians who practice beyond those regions where it is found with high frequency., Competing Interests: Declaration of competing interest K.M.M. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, CRISPR Therapeutics, Vifor Pharma, and Pharmacosmos; and research funding from Agios Pharmaceuticals and Pharmacosmos. M.D.C. reports consultancy fees from Novartis, Celgene/Bristol Myers Squibb, Vifor Pharma, and Ionis Pharmaceuticals; and research funding from Novartis, Celgene/Bristol Myers Squibb, La Jolla Pharmaceutical Company, Roche, Protagonist Therapeutics, and CRISPR Therapeutics. T.D.C. provides advisory support to Agios Pharma, Bristol Meyers Squibb, and Chiesi. K.H.M.K. reports consultancy fees from Agios Pharmaceuticals, Alexion Pharmaceuticals, Bristol Myers Squibb, Forma Therapeutics, Pfizer, NovoNordisk, and Vertex Pharmaceuticals; honoraria from Agios Pharmaceuticals and Bristol Myers Squibb; membership on an advisory committee for Bioverativ/Sanofi/Sangamo; and research funding from Agios Pharmaceuticals and Pfizer. H.A-S. reports consultancy fees from Novartis, Forma Therapeutics, Agios Pharmaceuticals, argenx, Moderna, Pharmacosmos, and Sobi; and research funding from Agios Pharmaceuticals, Amgen, Sobi, Novartis, and Vaderis Therapeutics. S.S. reports consultancy fees from Agios Pharmaceuticals, bluebird bio, Fulcrum Therapeutics, Chiesi, Celgene Corp (Bristol Myers Squibb), and Vertex; honoraria for CME activities from Plexus, CCO, and Physicians' Education Resource; advisory board travel from Agios Pharmaceuticals, Celgene Corp (Bristol Myers Squibb), and bluebird bio; research funding from Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, and Forma Therapeutics; and serving on a clinical trial steering committee for CRISPR/Vertex CTX001 for thalassemia. V.V. reports consultancy fees from Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Novartis, Vifor Pharma, Pharmacosmos, IONIS Pharmaceuticals, Inc., and DisperSol Technologies, LLC; and research funding from Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Novartis, Vifor Pharma, Pharmacosmos, IONIS Pharmaceuticals, Inc., DisperSol Technologies, LLC, and The Government Pharmaceutical Organization (GPO). A.T.T. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Vifor Pharma, and Pharmacosmos; and research funding from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Vifor Pharma, and Pharmacosmos., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Published: 2024
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34. 'Phenoconversion' in adult patients with β-thalassemia.

Author: Musallam KM, Barella S, Origa R, Ferrero GB, Lisi R, Pasanisi A, Longo F, Gianesin B, and Forni GL
Subjects: Adult, Humans, Blood Transfusion, Risk Factors, Italy, beta-Thalassemia therapy
Abstract: Rate and risk factors for phenoconversion from non-transfusion-dependent β-thalassemia (NTDT) to transfusion-dependent β-thalassemia (TDT) during a 10-year follow up of adult patients in Italy., (© 2024 Wiley Periodicals LLC.)
Published: 2024
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35. How I treat non-transfusion-dependent β-thalassemia.

Author: Saliba AN, Musallam KM, and Taher AT
Subjects: Humans, Iron Chelating Agents therapeutic use, Chelation Therapy adverse effects, beta-Thalassemia therapy, beta-Thalassemia drug therapy, Thalassemia drug therapy, Iron Overload diagnosis, Iron Overload etiology, Iron Overload therapy
Abstract: The intricate interplay of anemia and iron overload under the pathophysiological umbrella of ineffective erythropoiesis in non-transfusion-dependent β-thalassemia (NTDT) results in a complex variety of clinical phenotypes that are challenging to diagnose and manage. In this article, we use a clinical framework rooted in pathophysiology to present 4 common scenarios of patients with NTDT. Starting from practical considerations in the diagnosis of NTDT, we delineate our strategy for the longitudinal care of patients who exhibit different constellations of symptoms and complications. We highlight the use of transfusion therapy and novel agents, such as luspatercept, in the patient with anemia-related complications. We also describe our approach to chelation therapy in the patient with iron overload. Although tackling every specific complication of NTDT is beyond the scope of this article, we touch on the management of the various morbidities and multisystem manifestations of the disease., (© 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)
Published: 2023
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36. Arab Countries and Oncology Clinical Trials: A Bibliometric Analysis.

Author: Al-Shamsi HO, Abu-Gheida I, Sameh K, Tahoun NE, and Musallam KM
Abstract: The increasing cancer burden is a major health concern in Arab countries with cross-regional variations in cancer profiles. Given the limited oncology research output and scarce data on cancer trial participation in the Arab region, this study explored the therapeutic cancer trial landscape in Arab countries over the past 20 years. A bibliometric analysis of the PubMed database was conducted on primary publications of therapeutic trials with a participating Arab center. Arab countries participated in 320 published cancer-related therapeutic trials (2000-2021). During this period, there was a consistent increase in the number of trials, sample size, multiregional site participation, and number of randomized trials. However, most trials were small, did not receive external funding, and included a single Arab site. Compared with Arab-only trials, trials with joint non-Arab sites were larger ( p = 0.003) and more likely to be externally funded ( p < 0.001). Citation numbers and journal impact factors were higher in trial publications with joint non-Arab authorship than those without ( p < 0.001, for both). Despite improving conduct and publication records of oncology trials with Arab centers, cancer trial participation remains limited in Arab countries. Concerted efforts are required to encourage sponsorship and international collaboration in this region.
Published: 2023
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37. Epidemiology of clinically significant forms of alpha- and beta-thalassemia: A global map of evidence and gaps.

Author: Musallam KM, Lombard L, Kistler KD, Arregui M, Gilroy KS, Chamberlain C, Zagadailov E, Ruiz K, and Taher AT
Subjects: Pregnancy, Female, Humans, Prenatal Diagnosis methods, Hydrops Fetalis diagnosis, Asia, alpha-Thalassemia epidemiology, beta-Thalassemia epidemiology, Hemoglobins, Abnormal
Abstract: This systematic literature review assessed the global prevalence and birth prevalence of clinically significant forms of alpha- and beta-thalassemia. Embase, MEDLINE, and the Cochrane Library were searched for observational studies published January 1, 2000, to September 21, 2021. Of 2093 unique records identified, 69 studies reported across 70 publications met eligibility criteria, including 6 records identified from bibliography searches. Thalassemia prevalence estimates varied across countries and even within countries. Across 23 population-based studies reporting clinically significant alpha-thalassemia (e.g., hemoglobin H disease and hemoglobin Bart's hydrops fetalis) and/or beta-thalassemia (beta-thalassemia intermedia, major, and/or hemoglobin E/beta-thalassemia), prevalence estimates per 100 000 people ranged from 0.2 in Spain (over 2014-2017) to 27.2 in Greece (2010-2015) for combined beta- plus alpha-thalassemia; from 0.03 in Spain (2014-2017) to 4.5 in Malaysia (2007-2018) for alpha-thalassemia; and from 0.2 in Spain (2014-2017) to 35.7 to 49.6 in Iraq (2003-2018) for beta-thalassemia. Overall, the estimated prevalence of thalassemia followed the predicted pattern of being higher in the Middle East, Asia, and Mediterranean than in Europe or North America. However, population-based prevalence estimates were not found for many countries, and there was heterogeneity in case definitions, diagnostic methodology, type of thalassemia reported, and details on transfusion requirements. Limited population-based birth prevalence data were found. Twenty-seven studies reported thalassemia prevalence from non-population-based samples. Results from such studies likely do not have countrywide generalizability as they tended to be from highly specific groups. To fully understand the global prevalence of thalassemia, up-to-date, population-based epidemiological data are needed for many countries., (© 2023 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.)
Published: 2023
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38. Luspatercept for transfusion-dependent β-thalassemia: time to get real.

Author: Musallam KM, Sheth S, Cappellini MD, Kattamis A, Kuo KHM, and Taher AT
Abstract: Competing Interests: K.M.M. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, CRISPR Therapeutics, Vifor Pharma, and Pharmacosmos; and research funding from Agios Pharmaceuticals and Pharmacosmos. S.S. reports consultancy fees from Agios Pharmaceuticals, bluebird bio, Bristol Myers Squibb, Forma, and Chiesi; and serving on a clinical trial steering committee for CRISPR/Vertex CTX001 for thalassemia. M.D.C. reports consultancy fees from Novartis, Celgene/Bristol Myers Squibb, Vifor Pharma, and Ionis Pharmaceuticals; and research funding from Novartis, Celgene/Bristol Myers Squibb, La Jolla Pharmaceutical Company, Roche, Protagonist Therapeutics, and CRISPR Therapeutics. A.K. reports receiving advisory board fees and consulting fees from Agios Pharmaceuticals, Amgen, Celgene/Bristol Myers Squibb, CRISPR Therapeutics/Vertex, Ionis Pharmaceuticals, Novartis, and Vifor Pharma; and research support, paid to his institution, from Celgene/Bristol Myers Squibb and Novartis; honoraria for lectures, presentations, or speakers’ bureau from Bristol Myers Squibb, Chiesi Farmaceutuici, CRISPR Therapeutics/Vertex, and Novartis; and personal fees from Bristol Myers Squibb. K.H.M.K. reports consultancy fees from Agios Pharmaceuticals, Alexion Pharmaceuticals, Bristol Myers Squibb, Forma Therapeutics, Pfizer, NovoNordisk, and Vertex Pharmaceuticals; honoraria from Bristol Myers Squibb; membership on an advisory committee for Agios Pharmaceuticals and Bioverativ/Sanofi/Sangamo; and research funding from Agios Pharmaceuticals and Pfizer. A.T.T. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Vifor Pharma, and Pharmacosmos; and research funding from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, Vifor Pharma, and Pharmacosmos.
Published: 2023
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39. Establishment of the Abu Dhabi Emirate Thalassemia Longitudinal Cohort (AD-TLC): leveraging the power of observation.

Author: Musallam KM, Ahmed W, Almarshoodi MO, Trad O, Al Zein N, Siddique S, Shekary N, Daboul S, and Hashmi S
Subjects: Humans, United Arab Emirates epidemiology, Cohort Studies, Longitudinal Studies, Thalassemia
Published: 2023
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40. Psychometric evaluation of the NTDT-PRO questionnaire for assessing symptoms in patients with non-transfusion-dependent beta-thalassaemia.

Author: Taher AT, Musallam KM, Viprakasit V, Kattamis A, Lord-Bessen J, Yucel A, Guo S, Pelligra C, Shields AL, Shetty JK, Miteva D, Bueno LM, and Cappellini MD
Subjects: Adult, Humans, Quality of Life, Psychometrics, Reproducibility of Results, Surveys and Questionnaires, Fatigue diagnosis, Fatigue etiology, Hemoglobins, beta-Thalassemia complications, beta-Thalassemia therapy, Frailty
Abstract: Objectives: The non-transfusion-dependent beta-thalassaemia-patient-reported outcome (NTDT-PRO) questionnaire was developed for assessing anaemia-related tiredness/weakness (T/W) and shortness of breath (SoB) among patients with NTDT. Psychometric properties were evaluated using blinded data from the BEYOND trial (NCT03342404)., Design: Analysis of a phase 2, double-blind, randomised, placebo-controlled trial., Setting: USA, Greece, Italy, Lebanon, Thailand and the UK., Participants: Adults (≥18 years) (N=145) with NTDT who had not received a red blood cell transfusion within 8 weeks prior to randomisation, with mean baseline haemoglobin level ≤100 g/L., Measures: NTDT-PRO daily scores from baseline until week 24, and scores at select time points for the 36-Item Short Form Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Patient Global Impression of Severity (PGI-S)., Results: Cronbach's alpha at weeks 13-24 was 0.95 and 0.84 for the T/W and SoB domains, respectively, indicating acceptable internal consistency reliability. Among participants self-reporting no change in thalassaemia symptoms via the PGI-S between baseline and week 1, intraclass correlation coefficients were 0.94 and 0.92 for the T/W and SoB domains, respectively, indicating excellent test-retest reliability. In a known-groups validity analysis, least-squares mean T/W and SoB scores at weeks 13-24 were worse in participants with worse scores for the FACIT-F Fatigue Subscale (FS), SF-36v2 vitality or PGI-S. Indicating responsiveness, changes in T/W and SoB domain scores were moderately correlated with changes in haemoglobin levels, and strongly correlated with changes in SF-36v2 vitality, FACIT-F FS, select FACIT-F items and the PGI-S. Improvements in least-squares mean T/W and SoB scores were higher in participants with greater improvements in scores on other PROs measuring similar constructs., Conclusions: The NTDT-PRO demonstrated adequate psychometric properties to assess anaemia-related symptoms in adults with NTDT and can be used to evaluate treatment efficacy in clinical trials., Competing Interests: Competing interests: ATT—consulting fees from Agios Pharmaceuticals; research funding and consulting fees from Celgene/Bristol Myers Squibb, Ionis Pharmaceuticals, Novartis Pharmaceuticals and Vifor Pharma. KMM—consulting fees from Agios Pharmaceuticals, Celgene/Bristol Myers Squibb, CRISPR Therapeutics, Novartis, Pharmacosmos and Vifor Pharma. VV—research funding from Bristol Myers Squibb. AK—advisory board fees and consulting fees from Agios Pharmaceuticals, Celgene/Bristol Myers Squibb, Chiesi Farmaceutici, CRISPR Therapeutics/Vertex Pharmaceuticals, Ionis Pharmaceuticals, Novartis and Vifor Pharma; research support from Celgene/Bristol Myers Squibb and Novartis. JL-B, AY, JKS and LMB—employment by and stock/equity holder of Bristol Myers Squibb. SG—employment by Evidera; consultancy fees from Bristol Myers Squibb, Gilead and Janssen. CP—employment by Evidera. ALS—employment by Adelphi Values. DM—employment by Bristol Myers Squibb. MDC—advisory board fees from Celgene/Bristol Myers Squibb, CRISPR Therapeutics, Ionis Pharmaceuticals, Novartis, Novo Nordisk, Sanofi Genzyme and Vifor Pharma., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2023
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41. Overall and complication-free survival in a large cohort of patients with β-thalassemia major followed over 50 years.

Author: Forni GL, Gianesin B, Musallam KM, Longo F, Rosso R, Lisi R, Gamberini MR, Pinto VM, Graziadei G, Vitucci A, Bonetti F, Musto P, Piga A, Cappellini MD, and Borgna-Pignatti C
Subjects: Female, Humans, Male, Young Adult, Adult, Bone Marrow Transplantation, Risk Factors, beta-Thalassemia complications, beta-Thalassemia therapy, Heart Diseases, Thromboembolism complications
Abstract: We report data on survival and complications for a longitudinal cohort of 709 transfusion-dependent β-thalassemia major patients (51.1% males) born between 1970 and 1997 and followed through 2020 at seven major centers in Italy. Overall survival probability at 30 years was 83.6% (95%CI: 78.5-89.1) in the oldest birth cohort (1970-1974) compared with 93.3% (95%CI: 88.6-98.3) in the youngest birth cohort (1985-1997) (p = 0.073). Females showed better survival than males (p = 0.022). There were a total of 93 deaths at a median age of 23.2 years with the most frequent disease-related causes being heart disease (n = 53), bone marrow transplant (BMT) complication (n = 10), infection (n = 8), liver disease (n = 4), cancer (n = 3), thromboembolism (n = 2) and severe anemia (n = 1). There was a steady decline in the number of deaths due to heart disease from the year 2000 onwards and no death from BMT was observed after the year 2010. A progressive decrease in the median age of BMT was observed in younger birth cohorts (p < 0.001). A total of 480 (67.7%) patients developed ≥1 complication. Patients in younger birth cohorts demonstrated better complication-free survival (p < 0.001) which was comparable between sexes (p = 0.230). Independent risk factors for death in multivariate analysis included heart disease (HR: 4.63, 95%CI: 1.78-12.1, p = 0.002), serum ferritin >1000 ng/mL (HR: 15.5, 95%CI: 3.52-68.2, p < 0.001), male sex (HR: 2.75, 95%CI: 0.89-8.45, p = 0.078), and splenectomy (HR: 6.97, 95%CI: 0.90-54.0, p < 0.063). Survival in patients with β-thalassemia major continues to improve with adequate access to care, best practice sharing, continued research, and collaboration between centers., (© 2023 Wiley Periodicals LLC.)
Published: 2023
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42. Development of a Thalassemia International Prognostic Scoring System (TIPSS).

Author: Vitrano A, Musallam KM, Meloni A, Karimi M, Daar S, Ricchi P, Costantini S, Vlachaki E, Di Marco V, El-Beshlawy A, Hajipour M, Ansari SH, Filosa A, Ceci A, Singer ST, Naserullah ZA, Pepe A, Cademartiri F, Pollina SA, Scondotto S, Dardanoni G, Bonifazi F, Sankaran VG, Vichinsky E, Taher AT, and Maggio A
Subjects: Humans, Prognosis, Retrospective Studies, Portasystemic Shunt, Transjugular Intrahepatic adverse effects, beta-Thalassemia complications, beta-Thalassemia diagnosis, Thalassemia
Abstract: A prognostic scoring system that can differentiate β-thalassemia patients based on mortality risk is lacking. We analysed data from 3145 β-thalassemia patients followed through a retrospective cohort design for the outcome of death. An a priori list of prognostic variables was collected. β Coefficients from a multivariate cox regression model were used from a development dataset (n = 2516) to construct a formula for a Thalassemia International Prognostic Scoring System (TIPSS) which was subsequently applied to a validation dataset (n = 629). The median duration of observation was 10.0 years. The TIPSS score formula was constructed as exp (1.4 × heart disease + 0.9 × liver disease + 0.9 × diabetes + 0.9 × sepsis + 0.6 × alanine aminotransferase ≥42 IU/L + 0.6 × hemoglobin ≤9 g/dL + 0.4 × serum ferritin ≥1850 ng/mL). TIPSS score thresholds of greatest differentiation were assigned as <2.0 (low-risk), 2.0 to <5.0 (intermediate-risk), and ≥5.0 (high-risk). The TIPSS score was a good predictor for the outcome of death in the validation dataset (AUC: 0.722, 95%CI: 0.641-0.804) and survival was significantly different between patients in the three risk categories (P < 0.001). Compared to low-risk patients, the hazard ratio for death was 2.778 (95%CI: 1.335-5.780) in patients with intermediate-risk and 6.431 (95%CI: 3.151-13.128) in patients with high-risk. This study provides a novel tool to support mortality risk categorization for patients with β-thalassemia that could help management and research decisions., Competing Interests: Declaration of competing interest Khaled M. Musallam has been or is a consultant for Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, CRISPR Therapeutics and Vifor Pharma. Efthymia Vlachaki received hononaria from DEMO S.A. Pharmaceutical Industry and Novartis. Alessia Pepe is the principal investigator of the MIOT project that receives ‘non-profit support’ from industrial sponsorships (Chiesi Farmaceutici S.p.A. and Bayer) and she received speakers' honoraria from Chiesi Farmaceutici S.p.A. Ali T. Taher has been or is consultant for Novartis, Celgene Corp (Bristol Myers Squibb), Vifor Pharma, Silence Therapeutics and Ionis Pharmaceuticals; and received research funding from Novartis, Celgene Corp (Bristol Myers Squibb), La Jolla Pharmaceutical Company, Roche, Protagonist Therapeutics and Agios Pharmaceuticals. Vijay G Sankaran serves as an advisor to and/or has equity in Novartis, Forma, Cellarity, Ensoma, and Branch Biosciences. Aurelio Maggio has been or is a member of advisory boards for Novartis, Celgene Corp (Bristol Meyers Squibb) and Bluebird Bio. The remaining authors have no conflicts of interest to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)
Published: 2023
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43. Magnitude of cumulative iron overload correlates with the severity of anemia in untreated non-transfusion-dependent β-thalassemia.

Author: Musallam KM, Cappellini MD, Daar S, El-Beshlawy A, and Taher AT
Subjects: Humans, Iron, beta-Thalassemia complications, beta-Thalassemia therapy, Iron Overload etiology
Published: 2023
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44. Untreated Anemia in Nontransfusion-dependent β-thalassemia: Time to Sound the Alarm.

Author: Musallam KM, Taher AT, Cappellini MD, Hermine O, Kuo KHM, Sheth S, Viprakasit V, and Porter JB
Published: 2022
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45. Right in time: Mitapivat for the treatment of anemia in α- and β-thalassemia.

Author: Musallam KM, Taher AT, and Cappellini MD
Subjects: Humans, Erythropoiesis physiology, Pyruvate Kinase, Hemoglobins, beta-Thalassemia complications
Abstract: Kuo and colleagues 1 evaluated the safety and efficacy of mitapivat, an oral pyruvate kinase activator, in adults with non-transfusion-dependent α-thalassemia or β-thalassemia. The high rate of hemoglobin response and good tolerability encourages further development in thalassemia., Competing Interests: Declaration of interests K.M.M. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Agios Pharmaceuticals, CRISPR Therapeutics, Vifor Pharma, and Pharmacosmos. M.D.C. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Vifor Pharma, and Ionis Pharmaceuticals and research funding from Novartis, Celgene Corp (Bristol Myers Squibb), La Jolla Pharmaceutical Company, Roche, Protagonist Therapeutics, and CRISPR Therapeutics. A.T.T. reports consultancy fees from Novartis, Celgene Corp (Bristol Myers Squibb), Vifor Pharma, Silence Therapeutics, and Ionis Pharmaceuticals and research funding from Novartis, Celgene Corp (Bristol Myers Squibb), La Jolla Pharmaceutical Company, Roche, Protagonist Therapeutics, and Agios Pharmaceuticals., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Published: 2022
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46. Luspatercept for the treatment of anaemia in non-transfusion-dependent β-thalassaemia (BEYOND): a phase 2, randomised, double-blind, multicentre, placebo-controlled trial.

Author: Taher AT, Cappellini MD, Kattamis A, Voskaridou E, Perrotta S, Piga AG, Filosa A, Porter JB, Coates TD, Forni GL, Thompson AA, Tartaglione I, Musallam KM, Backstrom JT, Esposito O, Giuseppi AC, Kuo WL, Miteva D, Lord-Bessen J, Yucel A, Zinger T, Shetty JK, and Viprakasit V
Subjects: Activin Receptors, Type II, Adult, Double-Blind Method, Female, Humans, Immunoglobulin Fc Fragments, Male, Quality of Life, Recombinant Fusion Proteins, Treatment Outcome, alpha-Globins, Hemoglobin E therapeutic use, beta-Thalassemia complications, beta-Thalassemia drug therapy
Abstract: Background: In patients with non-transfusion-dependent β-thalassaemia, haemoglobin concentrations lower than 10 g/dL are associated with a higher risk of morbidity, mortality, and impaired quality of life. No drugs are specifically approved for anaemia management in patients with non-transfusion-dependent β-thalassaemia, other than transfusion therapy administered infrequently in accordance with patients' needs. We assessed the efficacy and safety of luspatercept versus placebo in patients with non-transfusion-dependent β-thalassaemia., Methods: We did a phase 2, randomised, double-blind, multicentre, placebo-controlled trial in 12 centres in six countries (Thailand [n=1], Lebanon [n=1], Greece [n=2], Italy [n=5], the UK [n=1], and the USA [n=2]). Eligible patients were aged 18 years or older, had confirmed diagnosis of β-thalassaemia or haemoglobin E/β-thalassaemia (concomitant α-globin deletion, mutation, or duplication were allowed), and a baseline haemoglobin concentration of 10·0 g/dL or lower. All patients were non-transfusion-dependent. Patients were randomly assigned (2:1) to luspatercept or placebo using an interactive response technology system and stratified by baseline haemoglobin concentration (≥8·5 g/dL vs <8·5 g/dL) and baseline Non-Transfusion-Dependent β-thalassaemia-Patient-Reported Outcome Tiredness/Weakness domain score (≥3 vs <3). All patients, study site staff, and sponsor representatives (who reviewed the data), except for designated individuals, were masked to drug assignment until the time the study was unblinded. Luspatercept or placebo was given once subcutaneously every 3 weeks for 48 weeks in the double-blind treatment period. Luspatercept was started at 1·0 mg/kg with titration up to 1·25 mg/kg, or reduction in the event of toxicity or excessive haemoglobin concentration increase. The primary endpoint was achievement of an increase from baseline of 1·0 g/dL or higher in mean haemoglobin concentration over a continuous 12-week interval during weeks 13-24, in the absence of transfusions. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT03342404, and is ongoing., Findings: Between Feb 5, 2018, and Oct 14, 2019, 160 patients were screened for eligiblity, of whom 145 were randomly assigned to luspatercept (n=96) or placebo (n=49). 82 (57%) patients were female and 63 (43%) were male. 44 (30%) patients were Asian, 87 (60%) were White, and 14 (10%) identified as another race. The study met its primary endpoint: 74 (77%) of 96 patients in the luspatercept group and none in the placebo group had an increase of at least 1·0 g/dL in haemoglobin concentration (common risk difference 77·1 [95% CI 68·7-85·5]; p<0·0001). The proportion of patients with serious adverse events was lower in the luspatercept group than in the placebo group (11 [12%] vs 12 [25%]). Treatment-emergent adverse events most commonly reported with luspatercept were bone pain (35 [37%]), headache (29 [30%]), and arthralgia (28 [29%]). No thromboembolic events or deaths were reported during the study., Interpretation: Luspatercept represents a potential treatment for adult patients with non-transfusion-dependent β-thalassaemia, for whom effective approved treatment options are scarce., Funding: Celgene and Acceleron Pharma., Competing Interests: Declaration of interests ATT reports receiving consulting fees from Agios Pharmaceuticals; and research funding and consulting fees from Celgene/Bristol Myers Squibb, Ionis Pharmaceuticals, Novartis Pharmaceuticals, and Vifor Pharma. MDC reports receiving advisory board fees from Agios Pharmaceuticals, Celgene/Bristol Myers Squibb, CRISPR Therapeutics/Vertex, Novo Nordisk, Sanofi Genzyme, Silence Therapeutics, and Vifor Pharma. AK reports receiving advisory board fees and consulting fees from Agios Pharmaceuticals, Amgen, Celgene/Bristol Myers Squibb, CRISPR Therapeutics/Vertex, Ionis Pharmaceuticals, Novartis, and Vifor Pharma; and research support, paid to his institution, from Celgene/Bristol Myers Squibb and Novartis; honoraria for lectures, presentations or speakers’ bureau from Bristol Myers Squibb, Chiesi Farmaceutuici, CRISPR Therapeutics/Vertex, and Novartis; and personal fees from Bristol Myers Squibb. SP reports receiving grant support, paid to his institution, from Novartis, and personal fees from bluebird bio and Celgene. AGP reports receiving grant support, paid to his institution, from Acceleron Pharma and Celgene, and advisory board fees from Celgene. AF reports advisory board fees from Celgene and grant support, paid to his institution, from bluebird bio and Novartis. JBP reports receiving advisory board fees from bluebird bio, Bristol Myers Squibb, Silence Therapeutics, and Vifor Pharma. TDC reports receiving consultancy fees from Agios Pharmaceuticals, bluebird bio, Bristol Myers Squibb/Celgene, Chiesi Farmaceutici, and Vifor Pharma. GLF reports receiving consulting fees and grant support, paid to his institution, from Agios Pharmaceuticals, Bristol Myers Squibb, and Novartis; and advisory board fees from Bristol Myers Squibb and Novartis; honoraria for lectures, presentations or speakers’ bureau from Bristol Myers Squibb and Novartis. AA Thompson reports receiving grant support from Baxalta, Biomarin, bluebird bio, Celgene/Bristol Myers Squibb, CRISPR Therapeutics/Vertex, Editas Medicine, and Novartis; and consulting fees from bluebird bio, Celgene/Bristol Myers Squibb, and CRISPR Therapeutics/Vertex; fees for leadership of fiduciary role in a committee or advocacy group from Global Blood Therapeutics; previous employment (last 12 months) at Ann & Robert H. Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; and current employment at Children's Hospital of Philadelphia, Philadelphia, PA, USA. IT reports receiving honoraria from Celgene. KMM reports receiving consulting fees from Agios Pharmaceuticals, Celgene/Bristol Myers Squibb, CRISPR Therapeutics, Novartis, and Vifor Pharma. JTB reports ending employment at Acceleron Pharma in the last 12 months and owning stock in Acceleron Pharma, and Bristol Myers Squibb. OE, W-LK, and DM report being employed by Bristol Myers Squibb. ACG, JL-B, AY, and JKS report being employed by and owning stock in Bristol Myers Squibb. TZ reports ending employment at Bristol Myers Squibb in the last 24 months and owning stock in Bristol Myers Squibb. EV and VV report no conflicts of interest., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
Published: 2022
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47. Tricuspid-valve regurgitant jet velocity as a risk factor for death in β-thalassemia.

Author: Derchi G, Musallam KM, Pinto VM, Graziadei G, Giuditta M, Barella S, Origa R, Casu G, Pasanisi A, Longo F, Casale M, Miceli R, Merella P, Gianesin B, Ameri P, Tartaglione I, Perrotta S, Piga A, Cappellini MD, and Forni GL
Subjects: Blood Flow Velocity, Humans, Risk Factors, Tricuspid Valve Insufficiency etiology, beta-Thalassemia complications
Published: 2022
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48. Clinical burden of hemophilia in older adults: Beyond bleeding risk.

Author: Hodroj MH, El Hasbani G, Al-Shamsi HO, Samaha H, Musallam KM, and Taher AT
Subjects: Adult, Aged, Aging, Humans, Hemophilia A complications, Hemophilia A epidemiology, Hemophilia A therapy, Neoplasms complications
Abstract: The prospect of hemophilia patients has dramatically improved in the last few decades with the introduction of various interventions that can effectively treat or prevent their bleeding risk. The life expectancy of patients can now reach that of the healthy population, but this has paved the way for several previously unrecognized morbidities to manifest in older adults with hemophilia. Such clinical complications are attributed to suboptimal management or poor access to effective therapy during childhood as well as chronicity and prolonged exposure to the underlying pathophysiology of the disease and its treatment. Complications common in the aging population are also becoming increasingly relevant in this vulnerable patient subgroup. In this review, we highlight peculiarities of such morbidities including chronic viral infections and liver disease, debilitating joint impairment and bone disease, cardiovascular and chronic kidney disease, and cancers. We also reflect on topics of special interest in adulthood such as sexuality., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Published: 2022
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49. Mortality in β-thalassemia patients with confirmed pulmonary arterial hypertension on right heart catheterization.

Author: Pinto VM, Musallam KM, Derchi G, Graziadei G, Giuditta M, Origa R, Barella S, Casu G, Pasanisi A, Longo F, Casale M, Miceli R, Merella P, Tartaglione I, Piga A, Cappellini MD, Gianesin B, and Forni GL
Subjects: Cardiac Catheterization, Familial Primary Pulmonary Hypertension, Humans, Pulmonary Arterial Hypertension, beta-Thalassemia complications, beta-Thalassemia therapy
Published: 2022
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50. Thalassemia and autoimmune diseases: Absence of evidence or evidence of absence?

Author: El Hasbani G, Musallam KM, Uthman I, Cappellini MD, and Taher AT
Subjects: Carrier State epidemiology, Comorbidity, Humans, Thalassemia therapy, beta-Thalassemia epidemiology, Autoimmune Diseases epidemiology, Thalassemia epidemiology
Abstract: The thalassemias are a group of inherited disorders of hemoglobin synthesis that continue to pause a global public health concern. The complex molecular and pathogenetic pathways involved in disease process lead to an array of comorbidities that require lifelong management. The disease and its treatment can also lead to alterations in immune function and a link to various autoimmune diseases has been frequently suggested. However, most data stem from single case reports and small studies that do not allow proper assessment of causal associations. Still, the high morbidity in thalassemia makes patients vulnerable to the added burden of coexisting autoimmune diseases, and special management considerations in this patient population are warranted. In this review, we explore insights and data from the literature on various autoimmune disease that have been observed in patients with thalassemia. The role of the thalassemia carrier state in modifying outcomes of patients with autoimmune diseases is also discussed., (Copyright © 2021. Published by Elsevier Ltd.)
Published: 2022
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