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]

NCT06572384

/ RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)

Interstitial lung disease (ILD) is a lung condition resulting in inflammation and stiffening of the lung, often associated with connective tissue diseases (CTDs). ILD causes reduction in lung volume, shortness of breath, cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions. The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile.

Start Date11 Sep 2024

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Belimumab

100 Translational Medicine associated with Belimumab

100 Patents (Medical) associated with Belimumab

1,324

Literatures (Medical) associated with Belimumab

01 Aug 2025·SEMINARS IN ARTHRITIS AND RHEUMATISM

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

Review

Author: Wei, James Cheng-Chung ; Fan, Yongsheng ; Chi, Gerald ; Ma, Chenhang ; Wang, Xinchang ; Xia, Shujun ; Wang, Weijie ; Zhao, Yu

OBJECTIVES:

We aimed to evaluate the risk of infectious complications of Belimumab with standard care in systemic lupus erythematosus (SLE).

METHODS:

We searched PubMed, Web of Science, EMBASE, and Cochrane databases for studies on SLE and Belimumab and evaluated the study quality using the Cochrane Collaboration tool (ROB 2). A random-effect model was employed to analyze the results. To evaluate publication bias, Egger's tests were used. We also performed subgroup analysis based on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and British Isles Lupus Assessment Group(BILAG). The study protocol has been registered in PROSPERO (CRD42023421255).

RESULTS:

Eight studies involving 8545 patients were included, of which four studies had a high attrition bias. The present study suggested that the risks of infectious complications including infection (RR=1.02, 95 %CI=(0.97,1.08), I²=7.7 %) or serious infections (RR=0.94, 95 %CI=(0.77,1.15), I²=0 %), nasopharyngitis(RR=1.02, 95 %CI=(0.79,1.33), I²=36 %), upper respiratory tract infection(RR=0.97, 95 %CI=(0.83,1.14), I²=20.6 %), urinary tract infection(RR=1.09, 95 %CI=(0.91,1.32), I²=0 %), herpes zoster (RR=0.75, 95 %CI=(0.54,1.05), I²=0 %)and influenza(RR=0.98, 95 %CI=(0.69,1.39), I²=0 %) were not significantly increased in patients who received Belimumab with standard care, except for bronchitis (RR=1.51, 95 %CI=(0.98,2.33), I²=23.7 %). Additionally, the subgroup analysis of SLEDAI and the proportion of patients with BILAG 1A/2B did not show any significant impact on infectious complications.

CONCLUSION:

Meta-analysis results demonstrated that intravenous (IV) Belimumab(≤10 mg/kg), along with standard care, did not significantly increase the risk of infectious complications in SLE patients having mild-to-moderate disease activity, except for bronchitis. Baseline disease activity and organ damage did not impact the risk of infectious complications.

01 Jul 2025·JOINT BONE SPINE

Comparative efficacy and safety of anifrolumab for belimumab-experienced and biologic-naïve patients with systemic lupus erythematosus: Results from the Kyushu Collagen Disease Network for Systemic Lupus Erythematosus (KCDN-SLE) registry

Letter

Author: Maekawa, Makiko ; Ueda, Naoyasu ; Tanaka, Atsushi ; Ayano, Masahiro ; Kushimoto, Kazuo ; Mishima, Koji ; Tsuru, Tomomi ; Doi, Goro ; Akahoshi, Mitsuteru ; Akashi, Koichi ; Ota, Shun-Ichiro ; Nakayama, Tsuyoshi ; Niiro, Hiroaki ; Horiuchi, Takahiko

01 Jul 2025·JOURNAL OF AUTOIMMUNITY

Stratifying patients by TNFSF13B genotype revealed increased flare and renal flare risk, but a greater benefit from belimumab: a potential biomarker for personalized treatment in systemic lupus erythematosus

Article

Author: Angioni, Maria Maddalena ; Chessa, Elisabetta ; Congiu, Fabio ; Cucca, Francesco ; Naitza, Micaela Rita ; Rizzo, Giulia ; Ragusa, Elena ; Floris, Alberto ; Deidda, Francesca ; Congia, Mattia ; Pireddu, Marta Paola ; Pitzalis, Maristella ; Piga, Matteo ; Cauli, Alberto

OBJECTIVE:

To examine whether SLE patients carrying the TNFSF13B variant (BAFF-var) differ in the risk of overall and renal flares and the benefits from belimumab.

METHODS:

This retrospective study analyzed data from a monocentric cohort of Sardinian SLE patients between January 2006 and December 2022. We recorded demographic, clinical, serological, and treatment variables. A flare was defined as a new SLE manifestation or worsening of an existing one that required a change in therapy. Renal flares, categorized as nephritic or nephrotic, were recorded. Soluble B-cell activating factor (sBAFF) levels were evaluated in patients naïve to any treatment. We used Kaplan-Meier curves, Cox regression, and Poisson regression to investigate the association between BAFF-var and flares.

RESULTS:

Among 233 screened patients, 194 (89.2 % female, 61.3 % BAFF-var carriers) were included. The mean age was 41.1 (±14.8) years, and the mean number of follow-up visits was 17 (±8). sBAFF levels increased according to BAFF-var genotype (p < 0.001). BAFF-var was significantly associated with an increased risk of flares (HR 1.5 per copy variant; 95 %CI 1.2-2.0; p = 0.002), and the frequency of flares (IRR 1.3 per copy variant; 95 %CI 1.1-1.6; p = 0.009). In 38 biopsy-confirmed lupus nephritis patients, the BAFF-var was associated with a higher risk of renal flare (HR 9.3; 95 %CI 1.7-49.5; p = 0.008). In 35 relapsing-remitting patients, belimumab reduced both the risk and frequency of flares, with higher effectiveness in patients carrying the BAFF-var (HR 0.12; 95 %CI 0.02-0.58; p = 0.009).

CONCLUSIONS:

Pending further validation, BAFF-var may serve as a predictive and prognostic biomarker for personalized treatment in SLE.

News (Medical) associated with Belimumab

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

20 Jun 2025

·www.fiercepharma.com

Europe's CHMP gives thumbs up to ExCellThera's blood cancer cell therapy Zemcelpro

Europe’s Committee for Medicinal Products for Human Use has recommended marketing authorization for ExCellThera’s novel cell therapy Zemcelpro in certain blood cancer patients. In a first for the bloc, Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for a new type of stem cell transplant therapy for certain blood cancer patients. The marketing endorsement was awarded to ExCellThera’s Zemcelpro and covers a recommended approval in adults with blood cancers that require an allogeneic hematopoietic stem cell transplantation (HSCT) following myeloablative conditioning for whom no other type of suitable donor cells is available.Zemcelpro contains stem cells from a donor’s umbilical cord blood, some of which have been grown and multiplied, the European Medicines Agency (EMA) said in a press release on the decision. By boosting the number of cells, Zemcelpro makes the stem cells from a small cord blood unit more effective, the European regulator explained. For several blood cancers—including leukemias, which are detected in the blood; lymphomas, which are found in the lymph nodes; and myelodysplastic syndrome and myelomas, which are diagnosed in the bone marrow—the only current curative treatment option is allogeneic HSCT. This type of transplant involves using donated stem cells to replace the patient’s bone marrow cells to form new marrow that produces healthy blood cells. The CHMP based its Zemcelpro recommendation on pooled analysis of two single-arm trials that included 25 patients. The studies found that 84% of patients who received Zemcelpro achieved neutrophil engraftment, when donor stem cells establish themselves in the recipient’s bone marrow and produce the white blood cells known as neutrophils within a median span of 20 days.Some 10,000 new blood cancer cases requiring bone marrow transplant crop up in Europe each year, ExCellThera estimates. Many of these patients do not have access to suitable donor cells largely because of the unavailability of matched donors, the company explained. ExCellThera said it expects to gain marketing authorization from the EMA in roughly two months' time. After winning an endorsement from the CHMP, prospective medicines must go before the European Commission for a final approval verdict.ExCellThera also plans to file for approval of Zemcelpro in the U.S., U.K. and other countries. Madrigal’s Rezdiffra among others gaining CHMP nodsThe committee has also given a thumbs up to Madrigal’s Rezdiffra for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a disease where fat cells accumulate in the liver causing chronic inflammation. If the drug gains marketing authorization, it would become the first treatment in the EU for the condition. Fifteen months ago, Rezdiffra became the first drug approved for MASH in the U.S. Also making the grade this month was Teva blockbuster Austedo for patients with moderate-to-severe tardive dyskinesia. The FDA approved the treatment in the indication eight years ago. Tardive dyskinesia is an irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities and can be caused by medications used to treat mental health or gastrointestinal conditions.Meanwhile, Pfizer spinout SpringWorks Therapeutics has picked up a CHMP nod for Ogsiveo in adults with progressing desmoid tumors, which are marked by noncancerous soft tissue growths in the limbs and abdomen that often cause severe pain and disfigurement. The FDA approved Ogsiveo in the same indication in 2023.Also gaining a positive recommendation from the CHMP was Partner Therapeutics’ Imreplys for the treatment of patients exposed to myelosuppressive doses of radiation with hematopoietic sub-syndrome of acute radiation syndrome. The medicine is known as Leukine in the U.S. where it was approved in 2018. CHMP signs off on label expansions for 6 drugsAside from new approval recommendations, the CHMP has also endorsed labeled expansions for a half-dozen established medicines. The committee gave a thumbs up to Ipsen’s Cabometyx as a second-line treatment for patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumors. The FDA signed off Cabometyx in the indication three months ago. The treatment, which has been on the market since 2016, brought home sales of $1.8 billion last year.Also winning CHMP recommendations were Johnson & Johnson blockbusters Darzalex, for smoldering multiple myeloma, and Imbruvica, for patients with previously treated mantle cell lymphoma who would be eligible for autologous stem cell transplant. AbbVie partners with J&J on Imbruvica.The committee further signed off on expansions for GSK’s lupus treatment Benlysta, Bayer’s prostate cancer drug Nubeqa and Sanofi’s multiple myeloma medicine Sarclisa. CHMP opens re-examination of Lilly’s KisunlaElsewhere, fifteen months after giving a thumbs down to Eli Lilly’s Alzheimer’s disease treatment Kisunla in March of last year, the CHMP will give the medication a second look. The regulator said that it re-opened its examination of Kisunla on June 2. The FDA signed off on Kisunla in July of last year, opening up competition with Eisai and Biogen’s Alzheimer's rival Leqembi.

Drug ApprovalCell TherapyClinical Result

100 Deals associated with Belimumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03068	Belimumab	L04AA26	DB08879

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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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


EULAR2024	Not Applicable	Lupus Nephritis \| Systemic Lupus Erythematosus	106	Subcutaneous Belimumab	glxbqdyocv(bbwtzucges) = PSL reduction ≥5 mg was achievable in active disease and positive C1q-binding immune complex kwrhxxqovx (samertdaet ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Lupus Erythematosus	-	Belimumab	tojdkuoiak(poevesgjoo) = rtpvnwrezi liorwbahne (nwlgvjywds )	Positive	05 Jun 2024
EULAR2024	Not Applicable	Pregnancy	17	Belimumab	tziybhifkc(opsindghaw) = thbfshkida gccjqbapau (nqckaxqpxq ) View more	Positive	05 Jun 2024
				Non-Belimumab	nrgkzisott(dqprarbgvb) = jpekmwsart eriazffewk (nvcqouqujs ) View more
EULAR2024	Not Applicable	Systemic Lupus Erythematosus BAFF cytokine	1,137	Belimumab	eihqlcyvjq(gtjdnrpzql) = yojularimz clwouexrjf (dmblcmoxgy ) View more	Positive	05 Jun 2024
				Belimumab (Standard of Care)	eihqlcyvjq(gtjdnrpzql) = wuddpaxnoo clwouexrjf (dmblcmoxgy ) View more
EULAR2024	Not Applicable	-	54	Belimumab	qnotzpgmge(xrkpjlvwke) = keosltfemz wapwsanrhj (qksstvzpst ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Systemic Lupus Erythematosus Maintenance anti-ds DNA \| RNP \| Sm ... View more	69	Belimumab (BE)	zubtycbdmo(lbksllffgu) = chasfysdcx pewjdmaevl (ohhhktjqwh ) View more	Positive	05 Jun 2024
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	lyavxqiimz(wiixazqian): OR = 1.7 (95% CI, 1.46 - 1.98), P-Value = <0.0001	Positive	05 Jun 2024
				Placebo
EULAR2024	Not Applicable	Systemic Lupus Erythematosus	-	Belimumab	rgxjafdiwv(nzwufocemg): HR = 0.72 (95% CI, 0.62 - 0.83), P-Value = <0.0001 View more	-	05 Jun 2024
				Placebo
EULAR2024	Not Applicable	Lupus Erythematosus	-	Belimumab	pijfuzjqsx(spmiadjppk) = tpritcwrbc cbbvcwrmpt (owibgfpevs, 6.3)	-	05 Jun 2024
				Control (no belimumab exposure)	pijfuzjqsx(spmiadjppk) = ufpkvwaluo cbbvcwrmpt (owibgfpevs, 6.5)
NCT04179032 (CTgov)	Phase 2	Systemic Lupus Erythematosus	25	Belimumab	cerxgyxiap(dkvidwacio) = lzxgcoljrj ploycdhdvk (gmapjujujw, ezzspqqdye - alvmiqvzkv) View more	-	26 Mar 2024

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