The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

Start Date01 Sep 2025

Sponsor / Collaborator

NYU Langone Health

NCT06716606

/ RecruitingPhase 3

An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

This is an open label extension (OLE) study of an ongoing randomized controlled clinical study 218224 (Parent Study). The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.

Start Date12 Dec 2024

Sponsor / Collaborator

GSK Plc

[+1]

NCT06381453

/ RecruitingPhase 2IIT

Belimumab in the Management of Autoimmune Hepatitis: a Multi-centre, Open-label Trial of Add-on Belimumab Therapy to Standard of Care

Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic & environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability & safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT<2x ULN & corticosteroids at a dose of

Start Date11 Dec 2024

Sponsor / Collaborator

University Health Network

[+1]

100 Clinical Results associated with Belimumab

100 Translational Medicine associated with Belimumab

100 Patents (Medical) associated with Belimumab

1,343

Literatures (Medical) associated with Belimumab

01 Dec 2025·IMMUNOLOGIC RESEARCH

Effects of belimumab on peripheral blood Breg cells and cytokines in childhood systemic lupus erythematosus

Article

Author: Qiu, Shan ; Peng, Qianqian ; Zhang, Ruifeng ; Chen, Na ; Lu, Qian ; Yuan, Tingting ; Zhong, Zhaowen ; Lv, Juan

To evaluate the therapeutic effectiveness of belimumab (BLM) in childhood systemic lupus erythematosus (cSLE) by analyzing peripheral blood Breg cell subsets and related cytokines at multiple time points post-treatment, compared with conventional therapy. From January 2023 to August 2023, 36 cSLE patients receiving BLM plus standard therapy (BLM group) and 35 receiving standard therapy alone (conventional group) were enrolled. Thirty age- and sex-matched healthy children were included as controls. Flow cytometry was used to detect absolute counts and ratios of peripheral Breg cell subsets at baseline, 6 weeks, 6 months, and 1 year. Serum cytokine levels (IL-2, IL-10, IL-21, IL-35, and IFN-γ) were measured by ELISA. After 6 weeks, IL-2, IL-21, and IFN-γ levels decreased significantly in both groups (P > 0.05 between groups); however, after 6 months and 1 year, these cytokines remained lower in the BLM group (all P < 0.05). IL-10 and IL-35 levels increased in both groups from week 6, with a milder increase in the BLM group (all P < 0.05). CD3⁻CD19⁺ B cells declined in both groups, with significant intergroup differences (P < 0.001). The BLM group showed a higher proportion of CD27⁺CD24⁺ B cells at week 6 compared to the conventional group (P < 0.05), but this reversed at 1 year (P < 0.05). CD38⁺CD24⁺ B cells were significantly higher in the BLM group at 6 months and 1 year (P < 0.001), while the conventional group showed no significant change after 6 weeks (P > 0.05). At baseline, the relative proportion of CD38⁺CD19⁺ B cells was higher in the BLM group than in the conventional treatment group (all P < 0.05). With ongoing treatment, both groups showed a decreasing trend in B cell proportions, with statistically significant differences observed within each group (all P < 0.05). Moreover, the decline in the BLM group was more pronounced compared to the conventional group at corresponding time points (all P < 0.05). Belimumab may exert immunomodulatory effects in childhood systemic lupus erythematosus by influencing peripheral Breg cell subsets and cytokine profiles. Compared with conventional therapy, it appears to provide more sustained regulation of certain immune parameters over time. These findings suggest its potential as a complementary therapeutic option targeting B cell dysregulation in cSLE, although further studies are needed to confirm these observations and clarify the underlying mechanisms.

01 Oct 2025·SEMINARS IN ARTHRITIS AND RHEUMATISM

Response to: ‘Critical Commentary ‘Infectious complications of Belimumab with standard care in systemic lupus erythematosus: A systematic review and meta-analysis’ by Saketh Sainag Mandiga et al

Letter

Author: Wang, Weijie ; Chen, Huihe ; Zhao, Yu

01 Oct 2025·SEMINARS IN ARTHRITIS AND RHEUMATISM

Commentary: infectious complications of Belimumab with standard care in systemic lupus erythematosus: a systematic review and meta-analysis

Letter

Author: Mandiga, Saketh Sainag ; Rajawat, Digvijay Singh ; Veldi, Venkata Dileep Kumar

News (Medical) associated with Belimumab

30 Jul 2025

·www.biospace.com

GSK to Inject ‘Tens of Billions’ in US Amid Trump’s Tariffs, Pipeline Reshuffles

iStock, Magdalena Wygralak CEO Emma Walmsley maintained that continued investment in the U.S. is a priority for the pharma to ensure its medicines for the country are supplied domestically. GSK will make a multi-billion-dollar investment in the U.S. in the coming years as the Trump administration’s tariffs materialize. “The U.S. is our number one priority market,” CEO Emma Walmsley told reporters on a media call Wednesday morning, while presenting the company’s second-quarter earnings report . “It’s in our plans to invest tens of billions [of] dollars in the U.S. over the next five years.” Walmsley did not reveal exactly how much money the company expects to spend, where it will go or what it will be used for. GSK continues to expand its footprint in the U.S., according to Walmsley, who noted that the pharma currently has five factories in the country and broke ground on a new manufacturing facility last quarter. GSK continues “to prioritize investments so that our portfolio in the U.S. is more and more supplied from the U.S,” she said. Walmsley’s statements come after the U.S. and the European Union arrived at a trade deal earlier this week, which adds a 15% tariff on pharmaceutical imports. Analysts expect these levies to cost the industry as much as $19 billion. GSK also reported on Wednesday a series of discontinuations in its pipeline. It is no longer investing in the anti-TIGIT antibody belrestotug, which it was developing alongside iTeos Therapeutics. The pharma in May broke off its engagement with the Massachusetts-based biotech following disappointing Phase II data in non-small cell lung cancer and head and neck cancer. GSK also revealed that it is pulling the plug on the antifungal agent ibrexafungerp, which it was advancing for invasive candidiasis in partnership with Scynexis. The FDA in September 2023 placed the Phase III MARIO study of ibrexafungerp in this indication under clinical hold due to a contamination issue. Scynexis revealed during its Q1 report in May that the hold had been lifted , but that GSK nevertheless wanted to terminate the study. GSK is also discontinuing the mid-stage vaccines GSK3437949 for malaria, GSK3536852 for shigella and GV118819 for tuberculosis. The pharma is also ending work on the Phase I vaccine GSK3536867 for salmonella. uygftv In the second quarter, GSK brought in £7.986 billion ($10.67 billion), representing a 6% year-on-year increase at constant exchange rates. Much of its growth was driven by its specialty medicines division, which jumped 15% to hit £3.327 billion ($4.45 billion) in the quarter. GSK’s vaccines business, earning £2.091 billion ($2.8 billion) in Q2, also delivered positive year-on-year growth. Some of GSK’s standout assets in Q2 include the asthma drug Trelegy Ellipta, which brought in £642 million ($858 million) in worldwide sales, and the lupus therapy Benlysta, which earned £372 million ($497 million). The pharma’s shingles vaccine Shingrix delivered £241 million ($322 million). Encouraged by what Walmsley called the company’s “strong momentum,” GSK raised its full-year turnover outlook. The pharma now expects to see growth toward the top end of its prior guidance, which is an increase of 3% to 5%.

VaccinePhase 2Phase 3Phase 1Clinical Result

08 Jul 2025

·www.pharmaceutical-technology.com

GSK acquires efimosfermin alfa from Boston Pharma for $2bn

Efimosfermin is a once-monthly subcutaneous injection to treat and prevent the progression of serious liver disease. Credit: Emily frost/Shutterstock. GSK has concluded the acquisition of efimosfermin alfa, an investigational therapeutic for serious liver disease (SLD), from Boston Pharmaceuticals in a $2bn deal. The transaction includes an upfront payment of $1.2bn and potential milestone payments of $800m. The acquisition, announced in May 2025, saw GSK purchase Boston Pharmaceuticals’ subsidiary BP Asset IX. This strategic move expands GSK’s pipeline to include treatments for liver, lung and kidney conditions. Efimosfermin, now in Phase III clinical development, is a once-monthly subcutaneous injection designed to treat and prevent the progression of SLD. GSK respiratory, immunology and inflammation research and development senior vice-president and global head Kaivan Khavandi stated: “The close of our acquisition for efimosfermin alfa represents a significant expansion of our hepatology pipeline aimed at addressing steatotic and viral drivers of liver disease. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Efimosfermin is a key growth opportunity for GSK with multiple development options and potential first launch in 2029. We look forward to unlocking the potential of this medicine for patients.” The new fibroblast growth factor 21 (FGF21) analog therapeutic targets metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and potentially alcohol-related liver disease (ALD). These conditions, which currently have limited treatment options, are leading causes of liver transplants in the US and pose a significant healthcare burden. GSK’s expertise in human genetics and disease phenotyping suggests that efimosfermin has the potential to treat advanced stages of SLD due to its direct antifibrotic mechanism. The therapy may also be used in combination with GSK’990, an siRNA therapeutic under development for different patient subsets with SLD. In June 2025, the US Food and Drug Administration approved GSK’s 200 mg/ml autoinjector of Benlysta for individuals aged five years and above with active lupus nephritis. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

AcquisitionPhase 3Drug Approval

25 Jun 2025

·pipelinereview.com

FDAapproves Benlysta (belimumab) Autoinjector for children with active lupus nephritis

PHILADELPHIA, PA, USA I June 24, 2025 I GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy. With this approval, GSK is expanding choices for belimumabtreatment, offering pediatric lupus nephritis patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home. The 200 mg/mL autoinjector was approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. Lupus nephritis is one of the most serious complications of lupus and occurs when the immune system mistakenly attacks the kidneys, leading to inflammation and possibly to organ damage. About 30-50% of children with lupus develop LN, typically within one to two years after their initial lupus diagnosis. 1,2 Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America said : “In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease can have long-term effects on a child’s growth and quality of life. 1,2 Having the Benlysta autoinjector provides a much-needed option that can help reduce the burden of frequent clinic visits for treatment and add greater flexibility for children and their families when considering continuity of care and routines of daily life.” Court Horncastle, Senior Vice President, and Head of US Specialty, GSK said: “For children and parents of children with lupus nephritis, this approval represents a choice in their care. Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community. GSK is driven by the belief that our therapeutic solutions should always prioritize improving patients’ well-being and easing their treatment journey, including for younger patients.” Caregivers of children who are currently using intravenous infusions of belimumabto manage their LN can work with their child’s healthcare provider to decide if at-home administration via autoinjector is appropriate. If so, the healthcare provider will administer treatment or the healthcare provider will provide instructions to the patients’ caregiver that will allow them to administer the medicine at home via an autoinjector. The 200 mg/mL autoinjector of belimumabwill be available for pediatric patients and their caregivers immediately. About systemic lupus erythematosus (SLE) and lupus nephritis (LN) Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. LN is a complication of SLE and occurs when the immune system mistakenly attacks the kidneys and leads to inflammation and potential organ damage. This inflammation can harm the kidney’s ability to remove waste from the blood. 1 LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis for people living with lupus. 3,4 Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of red and white blood cells in the urine. About Benlysta Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta does not bind B cells directly. The US FDA first approved Benlysta for the treatment of active SLE; it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population. Please see the US Prescribing Information for BENLYSTA INDICATION BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com . 1 Lupus Foundation of America. Childhood Lupus. Available at https://www.lupus.org/our-work/childhood-lupus . Accessed June 2025. 2 Francesco Peyronel, Giovanni M Rossi, Giulia Palazzini, Ludovica Odone, Carmela Errichiello, Giacomo Emmi, Augusto Vaglio, Early-onset lupus nephritis, Clinical Kidney Journal, Volume 17, Issue 8, August 2024, sfae212, https://doi-org.libproxy1.nus.edu.sg/10.1093/ckj/sfae212 . 3 National Kidney Foundation: Lupus Nephritis. Available at https://www.kidney.org/kidney-topics/lupus-nephritis . Accessed June 2025. 4 Hocaoǧlu M,, et al. Incidence, Prevalence, and Mortality of Lupus Nephritis: A Population-Based Study Over Four Decades Using the Lupus Midwest Network. Arthritis Rheumatol. 2023;75(4):567-573. doi:10.1002/art.42375. SOURCE: GlaxoSmithKline

Drug ApprovalImmunotherapy

100 Deals associated with Belimumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03068	Belimumab	L04AA26	DB08879

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lupus Nephritis	European Union	GlaxoSmithKline Trading Services Ltd.	13 Jul 2011
Lupus Nephritis	Iceland	GlaxoSmithKline Trading Services Ltd.	13 Jul 2011
Lupus Nephritis	Liechtenstein	GlaxoSmithKline Trading Services Ltd.	13 Jul 2011
Lupus Nephritis	Norway	GlaxoSmithKline Trading Services Ltd.	13 Jul 2011
Systemic Lupus Erythematosus	United States	GlaxoSmithKline LLC	09 Mar 2011

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bronchial Diseases	Phase 3	China	GSK Plc	12 Dec 2024
Bronchial Diseases	Phase 3	Japan	GSK Plc	12 Dec 2024
Bronchial Diseases	Phase 3	Argentina	GSK Plc	12 Dec 2024
Bronchial Diseases	Phase 3	South Korea	GSK Plc	12 Dec 2024
Connective Tissue Diseases	Phase 3	United States	GSK Plc	11 Sep 2024
Connective Tissue Diseases	Phase 3	China	GSK Plc	11 Sep 2024
Connective Tissue Diseases	Phase 3	Japan	GSK Plc	11 Sep 2024
Connective Tissue Diseases	Phase 3	Argentina	GSK Plc	11 Sep 2024
Connective Tissue Diseases	Phase 3	Australia	GSK Plc	11 Sep 2024
Connective Tissue Diseases	Phase 3	Belgium	GSK Plc	11 Sep 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04908865 (CTgov)	Phase 4	Systemic Lupus Erythematosus	67	Belimumab	kgooukchcv = fxcnvibvtx hskdwqjujc (vyhfitvfut, takwlpqtny - djicyqgydx) View more	-	23 Jul 2025
EULAR2024	Phase 3	Systemic Lupus Erythematosus baseline SLE disease duration \| baseline Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score \| baseline immunosuppressant (IS) use	3,086	Belimumab	ozvltnuhdf(fbfnugvdwo): OR = 1.7 (95% CI, 1.46 - 1.98), P-Value = <0.0001	Positive	05 Jun 2024
				Placebo
NCT04179032 (CTgov)	Phase 2	Systemic Lupus Erythematosus	25	Belimumab	zurwplwrvm(mhktgizslr) = dpinoyhxtd bmaugmkmpr (lyojizagzk, frxvnlvppt - ehmzattqno) View more	-	26 Mar 2024
NCT02347891 (BIM, CTgov)	Phase 2/3	Idiopathic Inflammatory Myopathies	17	Belimumab (Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase))	aqthxitfet = puidoqucag iavglzbwwn (ipxmbgctkg, ylrexisdbb - aakqocjgar) View more	-	09 Feb 2024
				Placebo+Belimumab (Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase))	aqthxitfet = zbnaiyyxho iavglzbwwn (ipxmbgctkg, pcatoserea - ozigpdnfrl) View more
NCT00424476 \| NCT01345253 \| NCT00410384 \| NCT01484496 (BLISS-SC, Pubmed) Manual	Phase 3	Systemic Lupus Erythematosus	3,225	Intravenous belimumab 1 mg/kg	oloezmlkgy(kcvwiqfbzd) = In total, 192 patients developed a renal flare after a median of 197 days. eybmlewrne (fxxzvgrolo ) View more	Positive	01 Feb 2024
				Intravenous belimumab 10 mg/kg
NCT01345253 (BEL113750, Pubmed \| Int J Rheum Dis) Manual	Phase 3	Systemic Lupus Erythematosus	100	Belimumab 10 mg/kg	laekuhwuei(nrnnqxdvaw) = mbbjcaddix tnogadvpak (vlkakisdtr )	Positive	01 Jan 2024
				Placebo	laekuhwuei(nrnnqxdvaw) = opnkgbcafy tnogadvpak (vlkakisdtr )
NCT01705977 (BASE, ACR2023)	Phase 4	Systemic Lupus Erythematosus autoantibody-positive	4,003	Belimumab (BEL)	lsddjsqwpy(bbivfcgctc) = wccphimwia hywhiwmixz (rrnbsmduap ) View more	Positive	13 Nov 2023
				Placebo (PBO)	lsddjsqwpy(bbivfcgctc) = opiqemhbjd hywhiwmixz (rrnbsmduap ) View more
NCT03244059 (BOTEGA, CTgov)	Phase 2	Emphysema \| Pulmonary Emphysema	17	Belimumab (Belimumab)	iycndgeprx(euzgjwovva) = pbkbtuegap gkxynmktoh (ecbgaadmxr, 5.4) View more	-	18 Jul 2023
				Placebo (Placebo)	iycndgeprx(euzgjwovva) = aplcjewbvb gkxynmktoh (ecbgaadmxr, 5.1) View more
EULAR2023	Phase 3	Systemic Lupus Erythematosus anti-dsDNA levels \| C3 \| C4 ... View more	1,932	Standard therapy (ST)	ccuqnsuxqu(tdqxcrpybz) = fupeboebla hwxleaqeil (yjwadnyjvn )	-	31 May 2023
EULAR2023	Not Applicable	Systemic Lupus Erythematosus	27	Intravenous Belimumab	iceviwwnru(lczckypacb) = vykmoskecd aisgbjkrft (knnzdhgtab ) View more	-	31 May 2023

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