Tags

Type your tag names separated by a space and hit enter

Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials.
Ann Rheum Dis 2012; 71(11):1833-8AR

Abstract

OBJECTIVE

To evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity.

METHODS

Data obtained after 52 weeks of treatment from two phase III trials (BLISS-52 and BLISS-76) comparing belimumab 1 and 10 mg/kg versus placebo, plus standard therapy, in 1684 autoantibody-positive patients were analysed post hoc for changes in British Isles Lupus Assessment Group (BILAG) and Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) organ domain scores.

RESULTS

At baseline, the domains involved in the majority of patients were musculoskeletal and mucocutaneous by both BILAG and SELENA-SLEDAI, and immunological by SELENA-SLEDAI. At 52 weeks, significantly more patients treated with belimumab versus placebo had improvement in BILAG musculoskeletal and mucocutaneous domains (1 and 10 mg/kg), and in SELENA-SLEDAI mucocutaneous (10 mg/kg), musculoskeletal (1 mg/kg) and immunological (1 and 10 mg/kg) domains. Improvement was also observed in other organ systems with a low prevalence (≤16%) at baseline, including the SELENA-SLEDAI vasculitis and central nervous system domains. Significantly fewer patients treated with belimumab versus placebo had worsening in the BILAG haematological domain (1 mg/kg) and in the SELENA-SLEDAI immunological (10 mg/kg), haematological (10 mg/kg) and renal (1 mg/kg) domains.

CONCLUSIONS

Belimumab treatment improved overall SLE disease activity in the most common musculoskeletal and mucocutaneous organ domains. Less worsening occurred in the haematological, immunological and renal domains.

Authors+Show Affiliations

Allegheny Singer Research Institute, West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, Pennsylvania 15224, USA. smanzi@wpahs.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22550315

Citation

Manzi, Susan, et al. "Effects of Belimumab, a B Lymphocyte Stimulator-specific Inhibitor, On Disease Activity Across Multiple Organ Domains in Patients With Systemic Lupus Erythematosus: Combined Results From Two Phase III Trials." Annals of the Rheumatic Diseases, vol. 71, no. 11, 2012, pp. 1833-8.
Manzi S, Sánchez-Guerrero J, Merrill JT, et al. Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. Ann Rheum Dis. 2012;71(11):1833-8.
Manzi, S., Sánchez-Guerrero, J., Merrill, J. T., Furie, R., Gladman, D., Navarra, S. V., ... Petri, M. A. (2012). Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. Annals of the Rheumatic Diseases, 71(11), pp. 1833-8. doi:10.1136/annrheumdis-2011-200831.
Manzi S, et al. Effects of Belimumab, a B Lymphocyte Stimulator-specific Inhibitor, On Disease Activity Across Multiple Organ Domains in Patients With Systemic Lupus Erythematosus: Combined Results From Two Phase III Trials. Ann Rheum Dis. 2012;71(11):1833-8. PubMed PMID: 22550315.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. AU - Manzi,Susan, AU - Sánchez-Guerrero,Jorge, AU - Merrill,Joan T, AU - Furie,Richard, AU - Gladman,Dafna, AU - Navarra,Sandra V, AU - Ginzler,Ellen M, AU - D'Cruz,David P, AU - Doria,Andrea, AU - Cooper,Simon, AU - Zhong,Z John, AU - Hough,Douglas, AU - Freimuth,William, AU - Petri,Michelle A, AU - ,, Y1 - 2012/05/01/ PY - 2012/5/3/entrez PY - 2012/5/3/pubmed PY - 2012/12/21/medline SP - 1833 EP - 8 JF - Annals of the rheumatic diseases JO - Ann. Rheum. Dis. VL - 71 IS - 11 N2 - OBJECTIVE: To evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity. METHODS: Data obtained after 52 weeks of treatment from two phase III trials (BLISS-52 and BLISS-76) comparing belimumab 1 and 10 mg/kg versus placebo, plus standard therapy, in 1684 autoantibody-positive patients were analysed post hoc for changes in British Isles Lupus Assessment Group (BILAG) and Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) organ domain scores. RESULTS: At baseline, the domains involved in the majority of patients were musculoskeletal and mucocutaneous by both BILAG and SELENA-SLEDAI, and immunological by SELENA-SLEDAI. At 52 weeks, significantly more patients treated with belimumab versus placebo had improvement in BILAG musculoskeletal and mucocutaneous domains (1 and 10 mg/kg), and in SELENA-SLEDAI mucocutaneous (10 mg/kg), musculoskeletal (1 mg/kg) and immunological (1 and 10 mg/kg) domains. Improvement was also observed in other organ systems with a low prevalence (≤16%) at baseline, including the SELENA-SLEDAI vasculitis and central nervous system domains. Significantly fewer patients treated with belimumab versus placebo had worsening in the BILAG haematological domain (1 mg/kg) and in the SELENA-SLEDAI immunological (10 mg/kg), haematological (10 mg/kg) and renal (1 mg/kg) domains. CONCLUSIONS: Belimumab treatment improved overall SLE disease activity in the most common musculoskeletal and mucocutaneous organ domains. Less worsening occurred in the haematological, immunological and renal domains. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/22550315/Effects_of_belimumab_a_B_lymphocyte_stimulator_specific_inhibitor_on_disease_activity_across_multiple_organ_domains_in_patients_with_systemic_lupus_erythematosus:_combined_results_from_two_phase_III_trials_ L2 - http://ard.bmj.com/cgi/pmidlookup?view=long&pmid=22550315 DB - PRIME DP - Unbound Medicine ER -