Belimumab for the treatment of recalcitrant cutaneous lupus

Background Belimumab is a monoclonal antibody that reduces B lymphocyte survival by blocking the binding of soluble human B lymphocyte stimulator (BLyS) to its B cell receptors. The utility of belimumab for management of resistant systemic lupus erythematosus (SLE) skin manifestations has not been reported. We present our experience of using this novel molecule for the successful management of cutaneous lupus at our center. Methods We studied five patients with significant SLE skin manifestations. All patients met 1997 American College of Rheumatology (ACR) SLE criteria and had failed multiple medications to control their skin disease. SLE disease activity indexes (SLEDAI), Cutaneous LE disease Area and Severity Index (CLASI) and patient’s global assessment (PGA) were recorded before and 16 weeks after belimumab treatment. Belimumab was added to concomitant standard therapy. Results All five patients demonstrated marked clinical improvement subsequent to belimumab treatment. The average time to clinical improvement after treatment initiation was 8–12 weeks. SLEDAI scores (median, range) improved in all the patients ((2, 2–6) to (0, 0–4); p = 0.025). PGA scores (median, range) were better in all patients ((3, 2–3) to (1, 0–1); p = 0.039). CLASI activity scores (median, range) improved dramatically in all patients ((17, 9–31) to (3, 2–14); p = 0.043). There was no worsening of the CLASI damage scores. The mean daily prednisone dose decreased significantly from 31 mg (±18.8) at baseline to 3 mg (± 2.7) (p = 0.042). Conclusion In this case series, the addition of belimumab to standard therapy improved the signs and symptoms of refractory cutaneous lupus. This is one of the first reports highlighting the potential utility of this medication for the treatment of severe skin involvement in SLE refractory to conventional therapies. Additional studies need to be performed to assess the use of belimumab in the treatment of cutaneous lupus.

[1]  J. Yazdany,et al.  Post-marketing experiences with belimumab in the treatment of SLE patients. , 2014, Rheumatic diseases clinics of North America.

[2]  D. Sackett,et al.  Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. , 1992, Arthritis and rheumatism.

[3]  M. Petri,et al.  Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial , 2011, The Lancet.

[4]  M. Petri,et al.  Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials , 2013, Annals of the rheumatic diseases.

[5]  D. Gladman,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 , 2012, Annals of the rheumatic diseases.

[6]  M. Dall'era,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 , 2016, Lupus Science & Medicine.

[7]  M. García-Carrasco,et al.  Cutaneous lupus erythematosus: clinical and immunological study of 308 patients stratified by gender , 2010, Clinical and experimental dermatology.

[8]  V. Werth,et al.  Cutaneous Lupus Erythematosus: An Update on Pathogenesis, Diagnosis and Treatment , 2016, American Journal of Clinical Dermatology.

[9]  C. Aranow A pilot study to determine the optimal timing of the Physician Global Assessment (PGA) in patients with systemic lupus erythematosus , 2015, Immunologic research.

[10]  J. Berlin,et al.  The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index): an outcome instrument for cutaneous lupus erythematosus. , 2005, The Journal of investigative dermatology.

[11]  J. Szepietowski,et al.  Treatment of cutaneous lupus erythematosus: current practice variations , 2016, Lupus.

[12]  M. Petri,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. , 2011, Arthritis and rheumatism.

[13]  M. Petri,et al.  Disease Control and Safety of Belimumab Plus Standard Therapy Over 7 Years in Patients with Systemic Lupus Erythematosus , 2014, The Journal of Rheumatology.

[14]  R. Sontheimer,et al.  Distinctive cutaneous subsets in the spectrum of lupus erythematosus. , 1981, Journal of the American Academy of Dermatology.

[15]  G. Obermoser,et al.  Overview of common, rare and atypical manifestations of cutaneous lupus erythematosus and histopathological correlates , 2010, Lupus.

[16]  M. Petri,et al.  Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response , 2012, Annals of the rheumatic diseases.

[17]  H. Kan,et al.  A Retrospective Administrative Claims Database Evaluation of the Utilization of Belimumab in US Managed Care Settings. , 2015, Clinical therapeutics.