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8. Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports

Author

Petri, Michelle, primary, Landy, Helain, additional, Clowse, Megan E B, additional, Gemzoe, Kim, additional, Khamashta, Munther, additional, Kurtinecz, Milena, additional, Levy, Roger A, additional, Liu, Andrew, additional, Marino, Rebecca, additional, Meizlik, Paige, additional, Pimenta, Jeanne M, additional, Sumner, Kelsey, additional, Tilson, Hugh, additional, Connolly, Mary Beth, additional, Wurst, Keele, additional, Harris, Julia, additional, Quasny, Holly, additional, Juliao, Patricia, additional, and Roth, David A, additional

Published
2022
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9. Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry

Author

Juliao, Patricia, primary, Wurst, Keele, additional, Pimenta, Jeanne M., additional, Gemzoe, Kim, additional, Landy, Helain, additional, Moody, M. Anthony, additional, Tilson, Hugh, additional, Covington, Deborah, additional, Moore, Tammy, additional, Marino, Rebecca, additional, Gilbride, Jennifer, additional, Liu, Andrew, additional, Meizlik, Paige, additional, and Petri, Michelle, additional

Published
2022
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12. Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports.

Author

Petri, Michelle, Landy, Helain, Clowse, Megan E. B., Gemzoe, Kim, Khamashta, Munther, Kurtinecz, Milena, Levy, Roger A., Liu, Andrew, Marino, Rebecca, Meizlik, Paige, Pimenta, Jeanne M., Sumner, Kelsey, Tilson, Hugh, Connolly, Mary Beth, Wurst, Keele, Harris, Julia, Quasny, Holly, Juliao, Patricia, and Roth, David A.

Published
2023
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13. Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry.

Author

Juliao, Patricia, Wurst, Keele, Pimenta, Jeanne M., Gemzoe, Kim, Landy, Helain, Moody, M. Anthony, Tilson, Hugh, Covington, Deborah, Moore, Tammy, Marino, Rebecca, Gilbride, Jennifer, Liu, Andrew, Meizlik, Paige, and Petri, Michelle

Abstract

Background: Belimumab is approved for active, autoantibody‐positive systemic lupus erythematosus (SLE) and lupus nephritis, but limited data exist regarding its use in pregnancy. The Belimumab Pregnancy Registry (BPR, GSK Study BEL114256; NCT01532310) was created to evaluate pregnancy and infant outcomes following belimumab exposure. Methods: Individuals with SLE exposed to belimumab from 4 months before and/or during pregnancy can enroll into the BPR. The primary outcome is major birth defects; secondary outcomes include miscarriages, stillbirths, elective termination, pre‐term birth, neonatal death, small for gestational age, and adverse infant outcomes during the first year of life. Belimumab exposure timing, concomitant medications, and other potential confounding factors are also collected. Data up to March 8, 2021, are reported descriptively. Results: From an expected sample size target of 500 prospective pregnancies with a known outcome, only 55 were enrolled in the study. Among these, two pregnancy losses and 53 pregnancies with a live birth outcome were reported. Ten of the 53 live birth pregnancies resulted in a major birth defect. Ten pregnancies were enrolled after the pregnancy outcome occurred and were examined retrospectively (four live births with no defects, four miscarriages, and two elective terminations). There was no indication or pattern of birth defects associated with belimumab. Conclusions: Low recruitment numbers for the BPR and incomplete information limit the conclusions regarding belimumab exposure during pregnancy. There was no pattern or common mechanism of birth defects associated with belimumab within the BPR data. [ABSTRACT FROM AUTHOR]

Published
2023
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15. Genetic evidence of importation of drug-resistant plasmodium falciparum to guatemala from the democratic republic of the Congo

Author

Patel, Jaymin C., Taylor, Steve M., Juliao, Patricia C., Parobek, Christian M., Janko, Mark, Gonzalez, Luis Demetrio, Ortiz, Lucia, Padilla, Norma, Tshefu, Antoinette K., Emch, Michael, Udhayakumar, Venkatachalam, Lindblade, Kim, and Meshnick, Steven R.

Subjects
Drug resistance -- Comparative analysis, Malaria -- Comparative analysis, Plasmodium falciparum -- Comparative analysis, Peacekeeping forces -- Comparative analysis, Health, United Nations
Abstract

Imported malaria threatens control and elimination efforts in countries that report low malaria transmission rates (1-3). In Central America, malaria transmission decreased by >50% during 2000-2010 (4); in 2010, the [...]

Published
2014
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16. Evaluation of residential structures not covered by aerial photographs used to generate a sampling frame – Nueva Santa Rosa, Guatemala

Author

Switchenko, Jeffrey M., primary, Roy, Sharon L., additional, Muñoz, Fredy, additional, Lopez, Gerard, additional, Rivera, Jose G., additional, Cuéllar, Victoria M., additional, Juliao, Patricia, additional, López, Beatriz, additional, Thornton, Andrew, additional, Patel, Jaymin C., additional, Alvarez, Maricruz, additional, Reyes, Lissette, additional, Derado, Gordana, additional, Arvelo, Wences, additional, and Lindblade, Kim A., additional

Published
2021
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18. An evaluation of water, sanitation, and hygiene status and household assets and their associations with soil-transmitted helminthiasis and reported diarrhea in Nueva Santa Rosa, Guatemala

Author

Rao, Gouthami, primary, Blackstock, Anna J., additional, Derado, Gordana, additional, Cuéllar, Victoria M., additional, Juliao, Patricia, additional, Alvarez, Maricruz, additional, López, Beatriz, additional, Muñoz, Fredy, additional, Thornton, Andrew, additional, Patel, Jaymin C., additional, Lopez, Gerard, additional, Rivera, Jose G., additional, Reyes, Lissette, additional, Arvelo, Wences, additional, Lindblade, Kim A., additional, and Roy, Sharon L., additional

Published
2021
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20. Histidine auxotrophy in commensal and disease-causing nontypeable Haemophilus influenzae

Author

Juliao, Patricia C., Marrs, Carl F., Xie, Jingping, and Gilsdorf, Janet R.

Subjects
Histidine -- Research, Hemophilus influenzae -- Genetic aspects, Hemophilus influenzae -- Research, Biosynthesis -- Research, Biological sciences
Abstract

Histidine biosynthesis is one of the best studied metabolic pathways in bacteria. Although this pathway is thought to be highly conserved within and between bacterial species, a previous study identified a genetic region within the histidine operon (his) of nontypeable strains of Haemophilus influenzae (NTHI) that was more prevalent among otitis media strains than among throat commensal NTHI strains. In the present study, we further characterized this region and showed that genes in the complete his operon (hisG, -D, -C, -NB, -H, -A, -F, and -IE) are >99% conserved among four fully sequenced NTHI strains, are present in the same location in these four genomes, and are situated in the same gene order. Using PCR and dot blot hybridization, we determined that the his' operon was significantly more prevalent in otitis media NTHI strains (106/121; 87.7%) than in throat strains (74/137; 54%) (prevalence ratio, 1.62; P < 0.0001), suggesting a possible role in middle ear survival and/or acute otitis media. NTHI strains lacking the his operon showed attenuated growth in histidine-restricted media, confirming them as h/s-negative auxotrophs. Our results suggest that the ability to make histidine is an important factor in bacterial growth and survival in the middle ear, where nutrients such as histidine may be found in limited amounts. Those isolates lacking the histidine pathway were still able to survive well in the throat, which suggests that histidine is readily available in the throat environment.

Published
2007

23. Highlights of an Expert Advisory Board on Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD) in Latin America

Author

Naranjo, Laura, primary, Torres-Duque, Carlos A, additional, Colodenco, Daniel, additional, Lopardo, Gustavo, additional, Rodriguez, Pablo, additional, Agra de Albuquerque-Neto, Aldo, additional, Hernandez-Zenteno, Rafael J, additional, Septien, Luis, additional, Chandler, Reynaldo, additional, Ortega-Barria, Eduardo, additional, Juliao, Patricia, additional, and Guzman-Holst, Adriana, additional

Published
2020
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25. Developmental components of resting ventilation among high- and low-altitude Andean children and adults

Author

Frisancho, A. Roberto, Juliao, Patricia C., Barcelona, Veronica, Kudyba, Carmela E., Amayo, Glenda, Davenport, Grecia, Knowles, Alicia, Sanchez, Dani, Villena, Mercedes, Vargas, Enrique, and Soria, Rudy

Subjects
Bolivia -- Health aspects, Aymaras -- Physiological aspects, Hypoxia -- Physiological aspects, Mountain life -- Physiological aspects, South American native peoples -- Bolivia, Physical anthropology -- Research, Anthropology/archeology/folklore
Abstract

This paper evaluates the age-associated changes of resting ventilation of 115 high- and low-altitude Aymara subjects, of whom 61 were from the rural Aymara village of Ventilla situated at an average altitude of 4,200 m and 54 from the rural village of Caranavi situated at an average altitude of 900 m. Comparison of the age patterns of resting ventilation suggests the following conclusions: 1) the resting ventilation (ml/kg/min) of high-altitude natives is markedly higher than that of low-altitude natives; 2) the age decline of ventilation is similar in both lowlanders and highlanders, but the starting point and therefore the age decline are much higher at high altitude; 3) the resting ventilation that characterizes high-altitude Andean natives is developmentally expressed in the same manner as it is at low altitude; and 4) the resting ventilation (ml/kg/min) of Aymara high-altitude natives is between 40-80% lower than that of Tibetans. KEY WORDS development; adaptation; high-altitude hypoxia; ventilation; Aymara; Quechua

Published
1999

28. Trends in all-cause pneumonia and otitis media in children aged &lt;2 years following pneumococcal conjugate vaccine introduction in Colombia

Author

Carrasquilla, Gabriel, Porras-Ramírez, Alexandra, Martinez, Sandra, DeAntonio, Rodrigo, Devadiga, Raghavendra, Talarico, Carla, Caceres, Diana C., Castrejon, Maria M., and Juliao, Patricia

Abstract

ABSTRACTIn Colombia, pneumococcal conjugate vaccines (PCVs) were implemented into the infant universal mass vaccination program in a stepwise manner; PCV-7 between 2009 and 2011 in different geographic regions/cities, with nationwide introduction of a 10-valent vaccine (PHiD-CV) in 2012. We aimed to describe trends in all-cause pneumonia mortality and overall mortality, and in the incidence of all-cause pneumonia and otitis media (OM) in Colombian children <2 y (y = years) of age, before and after PCV introduction. We obtained mortality and incidence data, nationally and for five major cities (Bogota, Medellin, Barranquilla, Cali and Cartagena) from 2005–2016 and 2008–2016, respectively, comparing mortality and incidence proportions in the post-PCV introduction period with those in the pre-PCV period. Overall mean reductions in all-cause pneumonia mortality was observed in the post-PCV period nationally (48.8%; 95%CI: 45.5–51.8%) and in four cities including Bogota (77.1%; 71.1–81.8%) and Medellin (56.4%; 44.1–65.9%); no substantial reduction was observed in Cartagena. Similar findings were observed for overall mortality. Reductions in all-cause pneumonia incidence were observed in Bogota (66.0%; 65.5–66.6%), Medellin (40.6%; 39.3–41.9%) and Cartagena (15.0%; 11.2–18.6%), while incidence increased in Barranquilla (78.5%; 68.4–89.2%) and Cali (125.5%; 119.2–132.0%). All-cause OM incidence fell in Medellin and Bogota (42.1–51.1%) but increased (95.8%) in Barranquilla. In conclusion, overall reductions in disease outcomes were observed following PCV introduction in most cities and nationwide. Decreasing trends in outcomes were observed prior to PCV introduction, and limited data points and data reporting issues may have influenced our results. (ClinicalTrials.gov: NCT02567747)

Published
2021
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29. Association of water quality with soil-transmitted helminthiasis and diarrhea in Nueva Santa Rosa, Guatemala, 2010

Author

Matanock, Almea, primary, Lu, Xin, primary, Derado, Gordana, primary, Cuéllar, Victoria M., primary, Juliao, Patricia, primary, Alvarez, Maricruz, primary, López, Beatriz, primary, Muñoz, Fredy, primary, Thornton, Andrew, primary, Patel, Jaymin C., primary, Lopez, Gerard, primary, Reyes, Lissette, primary, Arvelo, Wences, primary, Blackstock, Anna J., primary, Lindblade, Kim A., primary, and Roy, Sharon L., primary

Published
2018
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33. Genetic Evidence of Drug-Resistant Malarial Strain from the Democratic Republic of the Congo Imported to Guatemala

Author

Patel, Jaymin C., primary, Taylor, Steve M., additional, Juliao, Patricia C., additional, Parobek, Christian M., additional, Janko, Mark, additional, Gonzalez, Luis Demetrio, additional, Ortiz, Lucia, additional, Padilla, Norma, additional, Tshefu, Antoinette K., additional, Emch, Michael, additional, Udhayakumar, Venkatachalam, additional, Lindblade, Kim, additional, and Meshnick, Steven R., additional

Published
2014
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35. National Outbreak of Type A Foodborne Botulism Associated With a Widely Distributed Commercially Canned Hot Dog Chili Sauce

Author

Juliao, Patricia C., primary, Maslanka, Susan, additional, Dykes, Janet, additional, Gaul, Linda, additional, Bagdure, Satish, additional, Granzow-Kibiger, Lynae, additional, Salehi, Ellen, additional, Zink, Donald, additional, Neligan, Robert P., additional, Barton-Behravesh, Casey, additional, Lúquez, Carolina, additional, Biggerstaff, Matthew, additional, Lynch, Michael, additional, Olson, Christine, additional, Williams, Ian, additional, and Barzilay, Ezra J., additional

Published
2012
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36. Impact of a Hygiene Curriculum and the Installation of Simple Handwashing and Drinking Water Stations in Rural Kenyan Primary Schools on Student Health and Hygiene Practices

Author

Patel, Minal K., primary, Hoekstra, Robert M., additional, Nygren, Benjamin, additional, Otieno, Ronald, additional, Harris, Julie R., additional, Obure, Alfredo, additional, Kola, Steve, additional, Faith, Sitnah Hamidah, additional, Juliao, Patricia, additional, Quick, Robert, additional, Were, Vincent, additional, and Sadumah, Ibrahim, additional

Published
2012
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37. Norovirus outbreak of probable waterborne transmission with high attack rate in a Guatemalan resort

Author

Arvelo, Wences, primary, Sosa, Silvia M., additional, Juliao, Patricia, additional, López, María R., additional, Estevéz, Alejandra, additional, López, Beatriz, additional, Morales-Betoulle, María E., additional, González, Miguel, additional, Gregoricus, Nicole A., additional, Hall, Aron J., additional, Vinje, Jan, additional, Parashar, Umesh, additional, and Lindblade, Kim A., additional

Published
2012
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38. Addressing Inequities in Access to Health Products through the Use of Social Marketing, Community Mobilization, and Local Entrepreneurs in Rural Western Kenya

Author

Harris, Julie R., primary, Patel, Minal K., additional, Juliao, Patricia, additional, Suchdev, Parminder S., additional, Ruth, Laird J., additional, Were, Vincent, additional, Ochieng, Cliff, additional, Faith, Sitnah Hamidah, additional, Kola, Steven, additional, Otieno, Ronald, additional, Sadumah, Ibrahim, additional, Obure, Alfredo, additional, and Quick, Robert, additional

Published
2012
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39. Selling Sprinkles as part of a health products package may reduce fever and diarrhea incidence but not respiratory illness in preschool children in western Kenya

Author

Grant, Frederick Kobina Ebo, primary, Martorell, Reynaldo, additional, Ayala-Flores, Rafael, additional, Cole, Conrad R., additional, Ramakrishnan, Usha, additional, Laird, Ruth J., additional, Patel, Minal, additional, Juliao, Patricia C., additional, Quick, Rob, additional, and Suchdev, Parminder S., additional

Published
2012
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40. Monitoring the Marketing, Distribution, and Use of Sprinkles Micronutrient Powders in Rural Western Kenya

Author

Suchdev, Parminder S., primary, Ruth, Laird, additional, Obure, Alfredo, additional, Were, Vincent, additional, Ochieng, Cliff, additional, Ogange, Lorraine, additional, Owuor, Mercy, additional, Ngure, Frances, additional, Quick, Robert, additional, Juliao, Patricia, additional, Jung, Christina, additional, Teates, Kathryn, additional, Cruz, Kari, additional, and Jefferds, Maria Elena D., additional

Published
2010
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43. Identification of New Genetic Regions More Prevalent in Nontypeable Haemophilus influenzaeOtitis Media Strains than in Throat Strains

Author

Xie, Jingping, Juliao, Patricia C., Gilsdorf, Janet R., Ghosh, Debashis, Patel, Mayuri, and Marrs, Carl F.

Abstract

ABSTRACTNontypeable (NT) Haemophilus influenzaestrains cause significant respiratory illness and are isolated from up to half of middle ear aspirates from children with acute otitis media. Previous studies have identified two genes, lic2Band hmwA, that are associated with NT H. influenzaestrains isolated from the middle ears of children with otitis media but that are not associated with NT H. influenzaestrains isolated from the throats of healthy children, suggesting that they may play a role in virulence in otitis media. In this study, genomic subtraction was used to identify additional genetic regions unique to middle ear strains. The genome of NT H. influenzaemiddle ear strain G622 was subtracted from that of NT H. influenzaethroat strain 23221, and the resultant gene regions unique to the middle ear strain were identified. Subsequently, the relative prevalence of the middle ear-specific gene regions among a large panel of otitis media and throat strains was determined by dot blot hybridization. By this approach, nine genetic regions were found to be significantly more prevalent in otitis media strains. Classification tree analysis of lic2B, hmwA, and the nine new potential otitis media virulence genes revealed two H. influenzaepathotypes associated with otitis media.

Published
2006
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44. Genetic Evidence of Importation of Drug-Resistant Plasmodium falciparum to Guatemala from the Democratic Republic of the Congo

Author

Gonzalez, Luis Demetrio, Lindblade, Kim, Patel, Jaymin C., Meshnick, Steven R., Taylor, Steve M., Parobek, Christian M., Janko, Mark, Tshefu, Antoinette K., Padilla, Norma, Juliao, Patricia C., Emch, Michael, Ortiz, Lucia, and Udhayakumar, Venkatachalam

Subjects
education, parasitic diseases, humanities, 3. Good health
Abstract

Molecular markers and population genetics were effective tracking tools.Imported malaria threatens control and elimination efforts in countries that have low rates of transmission. In 2010, an outbreak of Plasmodium falciparum malaria was reported among United Nations peacekeeping soldiers from Guatemala who had recently returned from the Democratic Republic of the Congo (DRC). Epidemiologic evidence suggested that the soldiers were infected in the DRC, but local transmission could not be ruled out in all cases. We used population genetic analyses of neutral microsatellites to determine the outbreak source. Genetic relatedness was compared among parasites found in samples from the soldiers and parasite populations collected in the DRC and Guatemala; parasites identified in the soldiers were more closely related to those from the DRC. A phylogenetic clustering analysis confirms this identification with >99.9% confidence. Thus, results support the hypothesis that the soldiers likely imported malaria from the DRC. This study demonstrates the utility of molecular genotyping in outbreak investigations.

45. Virulence factors in nontypeable <italic>Haemophilus influenzae</italic> contributing to otitis media.

Author

Juliao, Patricia C.

Subjects
Contributing, Factors, Genomic Subtraction, Haemophilus Influenzae, Molecular Epidemiology, Nontypeable, Otitis Media, Virulence
Abstract

Nontypeable Haemophilus influenzae (NTHi) is an important cause of acute otitis media (OM), infection of the middle ear. Although the pathogenic mechanisms are not well understood, NTHi may contain special virulence features that facilitate development of otitis media. To identify unique genetic regions specific for the genome of an OM pathogenic nontypeable isolate, G622, compared to the genome of a nonpathogenic nontypeable throat strain (TH), 23221, genomic subtraction was used in this study. Subsequently, the resultant middle ear specific gene regions were used to determine their relative prevalences among a large panel of OM and TH strains using dot blot hybridization. With this approach, nine new genetic regions were significantly more prevalent in OM strains compared to TH strains (sJPX124, 84, 163, 161, 147, 173, 101, 120, 132). Classification tree analysis of lic2b, hmwA, and the nine regions reveals two H. influenzae pathotypes associated with OM. To determine length, location and possible allelic variation of each of these genetic regions, we performed PCR based genomic walking on OM strain G622 and TH strain 23221. Follow up experiments in region sJPX132, associated with histidine biosynthesis, revealed a 7.5 kb deletion associated with the complete his operon. Isolates lacking this operon were unable to grow properly in histidine restricted liquid culture. This observation suggests that histidine biosynthesis may be important in bacterial survival in the middle ear where nutrients, such as histidine, are found in limited amounts. Further characterization of the remaining eight genetic regions suggest that many of these genetic regions identified through genomic subtraction may be markers for larger more complex regions that may be associated with OM pathogenesis. Most of these regions contain gene(s) involved with more conserved functions such as amino acid biosynthesis, nutrient uptake and energy metabolism rather than the traditionally defined virulence factors in NTHi such as adhesins, IgA protease, and lipooligosaccharides. These findings suggest that these previously thought conserved genes may be an added benefit to survival in certain niches, such as the middle ear, rather than strictly essential in H. influenzae.

Published
2006

46. Addressing Inequities in Access to Health Products through the Use of Social Marketing, Community Mobilization, and Local Entrepreneurs in Rural Western Kenya

Author

R. Harris, Julie, K. Patel, Minal, Juliao, Patricia, S. Suchdev, Parminder, J. Ruth, Laird, Were, Vincent, Ochieng, Cliff, Hamidah Faith, Sitnah, Kola, Steven, Otieno, Ronald, Sadumah, Ibrahim, Obure, Alfredo, and Quick, Robert

Abstract

While social marketing can increase uptake of health products in developing countries, providing equitable access is challenging. We conducted a 2-year evaluation of uptake of WaterGuard, insecticide-treated bednets (ITNs), and micronutrient Sprinkles in Western Kenya. Sixty villages were randomly assigned to intervention and comparison groups. Following a baseline survey (BL), a multifaceted intervention comprising social marketing of these products, home visits by product vendors from a local women’s group (Safe Water and AIDS Project, or SWAP), product promotions, and modeling of water treatment and safe storage in was implemented in intervention villages. Comparison villages received only social marketing of WaterGuard and ITNs. We surveyed again at one year (FU1), implemented the intervention in comparison villages, and surveyed again at two years (FU2). At BL, <3% of households had been visited by a SWAP vendor. At FU1, more intervention than comparison households had been visited by a SWAP vendor (39% versus 9%, P<0.0001), and purchased WaterGuard (14% versus 2%, P<0.0001), Sprinkles (36% versus 6%, P<0.0001), or ITNs (3% versus 1%, P<0.04) from that vendor. During FU2, 47% and 41% of original intervention and comparison households, respectively, reported ever receiving a SWAP vendor visit (P=0.16); >90% those reported ever purchasing a product from the vendor. WaterGuard (P=0.02) and ITNs (P=0.005) were purchased less frequently by lower-SES than higher-SES households; Sprinkles, the least expensive product, was purchased equally across all quintiles.

Published
2012
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48. Real-world effectiveness of belimumab in patients with lupus in China: RELIABLE observational cohort study protocol.

Author

Fan L, Tang Z, He X, He X, Zhang Z, and Juliao P

Subjects
Humans, China, Treatment Outcome, Retrospective Studies, Observational Studies as Topic, Severity of Illness Index, Prospective Studies, Adult, Female, Cohort Studies, Lupus Erythematosus, Systemic drug therapy, Antibodies, Monoclonal, Humanized therapeutic use, Immunosuppressive Agents therapeutic use
Abstract

Introduction: The efficacy of belimumab in SLE has been demonstrated in randomised clinical trials, and its real-world effectiveness has been shown in studies in several countries. While belimumab was approved for treating SLE in China in 2019, data on its benefit in clinical practice are limited. This study will evaluate belimumab's effectiveness in China, using practical clinical measures, such as Lupus Low Disease Activity State (LLDAS), to add to the body of real-world evidence., Methods and Analysis: The Real-world Effectiveness of beLImumAB in patients with systemic Lupus Erythematosus in China (RELIABLE) is an ambidirectional, observational descriptive cohort study across approximately 15 centres in China. Adults with SLE newly initiating belimumab with ≥1 measure of all five LLDAS components (SLE Disease Activity Index-2000; no new lupus disease activity; Physician Global Assessment; prednisolone-equivalent dose; immunosuppressants/biologics use) in the 3 months preceding belimumab initiation (index date) will be eligible and retrospectively and/or prospectively enrolled, depending on data availability. The retrospective follow-up will be ≤6 months, and retrospective and prospective patients will have a maximum 24-month follow-up. The primary objectives will be to describe the proportion of patients achieving LLDAS at 12 and 24 months post-index. The key secondary objective will be to describe the proportion of patients achieving LLDAS and each component at 3, 6, 9 and 18 months post-index. All data will be analysed descriptively; a statistical estimand will be applied to account for intercurrent events expected in a real-world setting., Ethics and Dissemination: This study will comply with all applicable laws regarding patient privacy; institutional review board approval will be obtained before the study commencement., Conclusions: This study will evaluate belimumab's effectiveness in patients with SLE initiating belimumab in clinical practice in China. Using LLDAS will provide clinicians with valuable insights into the impact of belimumab on the treat-to-target strategy with a relevant measure that can be repeated across the clinical practice., Competing Interests: Competing interests: LF, ZT, XinH and PJ are employees of GSK; PJ holds shares in the company. XTH is an employee of IQVIA. ZZ received grant/research support from GSK., (© 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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