Open access

Research Article

25 April 2018

An indirect comparison of intravenous and subcutaneous belimumab efficacy in patients with SLE and high disease activity

Authors: Sulabha Ramachandran [email protected], Daniel Parks, Milena Kurtinecz, David A Roth, and Rafael Alfonso-CristanchoAuthor Info & Affiliations

Publication: J. Comp. Eff. Res.

Volume 7, Number 6

https://doi.org/10.2217/cer-2017-0085

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Abstract

Aim: To compare the efficacy of intravenous (IV) and subcutaneous (SC) belimumab plus standard therapy in patients with active, autoantibody-positive systemic lupus erythematosus and high disease activity (HDA). Patients & methods: An indirect treatment comparison using patient-level data of patients with HDA from three belimumab IV Phase III randomized controlled trials (BLISS-52 [BEL110751]; BLISS-76 [BEL110752]; Northeast Asia study [BEL113750]) and one belimumab SC randomized controlled trial (BLISS-SC [BEL112341]). Results: Similar efficacy results were identified between the belimumab formulations and greater improvements in efficacy endpoints were observed for both formulations compared with placebo. Conclusion: This indirect treatment comparison provides further evidence of the efficacy of belimumab IV and SC in patients with systemic lupus erythematosus and HDA, compared with standard therapy.

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References

Papers of special note have been highlighted as: • of interest; •• of considerable interest

1.

Zhang J, Roschke V, Baker KP et al. Cutting edge: a role for B lymphocyte stimulator in systemic lupus erythematosus. J. Immunol. 166(1), 6–10 (2001).

2.

Arbuckle MR, McClain MT, Rubertone MV et al. Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N. Engl. J. Med. 349(16), 1526–1533 (2003).

3.

Diamond B, Bloom O, Al Abed Y et al. Moving towards a cure: blocking pathogenic antibodies in systemic lupus erythematosus. J. Intern. Med. 269(1), 36–44 (2011).

4.

Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum. 40(9), 1725 (1997).

5.

Tan EM, Cohen AS, Fries JF et al. The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheumatol. 25(11), 1271–1277 (1982).

6.

Barr SG, Zonana-Nacach A, Magder LS, Petri M. Patterns of disease activity in systemic lupus erythematosus. Arthritis Rheum. 42(12), 2682–2688 (1999).

7.

Mcelhone K, Abbott J, Teh L-S. A review of health related quality of life in systemic lupus erythematosus. Lupus. 15(10), 633–643 (2006).

8.

van Vollenhoven RF, Petri MA, Cervera R et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann. Rheum. Dis. 71(8), 1343–1349 (2012).

• It is a pooled subgroup analysis of BLISS-52 (BEL110752) and BLISS-76 (BEL110751) to identify factors predicting response to belimumab treatment.

9.

Baker KP, Edwards BM, Main SH et al. Generation and characterization of LymphoStat-B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator. Arthritis Rheum. 48(11), 3253–3265 (2003).

10.

Gottschalk TA, Tsantikos E, Hibbs ML. Pathogenic inflammation and its therapeutic targeting in systemic lupus erythematosus. Front. Immunol. 6, 550 (2015).

11.

Kuhn A, Bonsmann G, Anders HJ et al. The diagnosis and treatment of systemic lupus erythematosus. Dtsch. Arztebl. Int. 112(25), 423–432 (2015).

12.

European Medicines Agency. Summary of product characteristics – Benlysta (belimumab) (2011). www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002015/WC500110150.pdf.

13.

Benlysta (belimumab) Prescribing Information. (ID: 3483179) (2014). www.accessdata.fda.gov/drugsatfda_docs/label/2016/125370s055lbl.pdf.

14.

Bertsias G, Ioannidis J, Boletis J et al. EULAR recommendations for the management of systemic lupus erytematosus (SLE) report of a Task Force of the European Standing Committee for International Clinical Studies including Therapeutics (ESCISIT). Ann. Rheum. Dis. 67, 195–205 (2008).

15.

Ho A, Barr SG, Magder LS, Petri M. A decrease in complement is associated with increased renal and hematologic activity in patients with systemic lupus erythematosus. Arthritis Rheum. 44(10), 2350–2357 (2001).

16.

Nasiri S, Karimifar M, Bonakdar ZS, Salesi M. Correlation of ESR, C3, C4, anti-DNA and lupus activity based on British Isles Lupus Assessment Group Index in patients of rheumatology clinic. Rheumatol. Int. 30(12), 1605–1609 (2010).

17.

US FDA. Guidance for industry on systemic lupus erythematosus: developing medical products for treatment. Silver Spring, MD: US Food and Drug Administration (2010). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072063.pdf.

18.

Furie RA, Petri MA, Wallace DJ et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 61(9), 1143–1151 (2009).

19.

Furie R, Petri M, Zamani O et al. A Phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 63(12), 3918–3930 (2011).

•• It is one of the four randomized controlled trials used within this indirect treatment comparison.

20.

Navarra SV, Guzman RM, Gallacher AE et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, Phase III trial. Lancet 377(9767), 721–731 (2011).

•• It is one of the four randomized controlled trials used within this indirect treatment comparison.

21.

Zhang F, Bae SC, Bass D et al. A pivotal Phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann. Rheum. Dis. 77(3), 355–363 (2018).

•• It is one of the four randomized controlled trials used within this indirect treatment comparison.

22.

GlaxoSmithKline. GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus (July 2017). www.gsk.com/en-gb/media/press-releases/gsk-receives-fda-approval-for-a-new-self-injectable-formulation-of-benlysta-belimumab-for-systemic-lupus-erythematosus/.

23.

GlaxoSmithKline. GSK receives European marketing authorisation for self-injectable formulation of Benlysta for the treatment of systemic lupus erythematosus (November 2017). www.gsk.com/en-gb/media/press-releases/gsk-receives-european-marketing-authorisation-for-self-injectable-formulation-of-benlysta-for-the-treatment-of-systemic-lupus-erythematosus/.

24.

Stohl W, Schwarting A, Okada M et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 69(5), 1016–1027 (2017).

•• It is one of the four randomized controlled trials used within this indirect treatment comparison.

25.

Yapa SW, Roth D, Gordon D, Struemper H. Comparison of intravenous and subcutaneous exposure supporting dose selection of subcutaneous belimumab systemic lupus erythematosus Phase III program. Lupus 25(13), 1448–1455 (2016).

• It is a PK model comparing belimumab IV and SC formulations from two Phase I studies.

26.

European Medicines Agency. Benlysta (belimumab): EPAR summary for the public (2012). www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002015/WC500110153.pdf.

27.

Hoaglin DC, Hawkins N, Jansen JP et al. Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 2. Value Health 14(4), 429–437 (2011).

28.

Lunn DJ, Thomas A, Best N, Spiegelhalter D. WinBUGS-a Bayesian modelling framework: concepts, structure, and extensibility. Stat. Comput. 10(4), 325–337 (2000).

29.

Buyon JP, Petri MA, Kim MY et al. The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: a randomized trial. Ann. Intern. Med. 142(12 Pt 1), 953–962 (2005).

30.

Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus 8(8), 685–691 (1999).

31.

Petri M, Kim MY, Kalunian KC et al. Combined oral contraceptives in women with systemic lupus erythematosus. N. Engl. J. Med. 353(24), 2550–2558 (2005).

32.

Pope JE. Measuring flares in systemic lupus erythematosus. Rheumatology (Oxford) 53(12), 2134–2135 (2014).

33.

Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J. Clin. Epidemiol. 50(6), 683–691 (1997).

34.

Wallace DJ, Stohl W, Furie RA et al. A Phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Care Res. 61(9), 1168–1178 (2009).

35.

Lee YH, Song GG. Comparative efficacy and safety of intravenous or subcutaneous belimumab in combination with standard therapy in patients with active systemic lupus erythematosus: a Bayesian network meta-analysis of randomized controlled trials. Lupus 27(1), 112–119 (2018).

• It is an additional indirect treatment comparison of the efficacy and safety of intravenous and subcutaneous belimumab in patients with SLE.

36.

Collins CE, Dall'era M, Kan H et al. Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA. Lupus Sci. Med. 3(1), e000118 (2016).

• It is an observational cohort study examining disease activity and outcomes in patients with SLE being treated with IV belimumab.

37.

Iaccarino L, Bettio S, Reggia R et al. Effects of belimumab on flare rate and expected damage progression in patients with active systemic lupus erythematosus. Arthritis Care Res. 69(1), 115–123 (2017).

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