OnabotulinumtoxinA for Systemic Sclerosis-associated Raynaud’s Phenomenon: A Multi-Institutional Study on Accessibility and Effectiveness

November 2021 | Volume 20 | Issue 11 | Editorials | 1257 | Copyright © November 2021


Published online October 27, 2021

Bina Kassamali BA,a,b,* Sheena Desai BS,a,c,* Michelle S. Min MD MS,a,b Daniel R. Mazori MD,a,b Camila Villa-Ruiz MPH,a,d Kylee JB Kus,a,e BS Gabriela A. Cobos MD,a,b Joseph Merola MD MMSca,b,f Avery LaChance MD MPH,a,b,# Ruth Ann Vleugels MD MPH MBAa,b,#

aDepartment of Dermatology, Brigham and Women's Hospital, Boston, MA
bHarvard Medical School, Boston, MA
cTufts University School of Medicine, Boston, MA
dPonce Health Sciences University, School of Medicine, Ponce, PR
eOakland University William Beaumont School of Medicine, Rochester, MI
fDepartment of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, Boston, MA

*Denotes co-first authors
#Denotes co-senior authors



effective treatment for SSc-associated RP, this therapy remains an off-label use, and patients, particularly those with public health insurance, have limited success in acquiring insurance coverage for this treatment. This difference in coverage based on insurance status, despite treatment effectiveness, highlights an important access issue. Furthermore, there are no FDAapproved treatments for RP as it is an orphan disease, making it challenging to study in controlled clinical trials. Given the clinical benefits of off-label onabotulinumtoxinA for refractory SSc-associated RP, insurance approval should ideally not hinge on FDA approval alone. A reevaluation of the policies that determine coverage of therapies for RP is warranted.

DISCLOSURES

The authors have no conflicts of interest to declare.

REFERENCES

1. Dhaliwal K, Griffin MF, Salinas S, Howell K, Denton CP, Butler PEM. Optimisation of botulinum toxin type a treatment for the management of Raynaud's phenomenon using a dorsal approach: a prospective case series. Clin Rheumatol. 2019;38(12):3669-3676. doi:10.1007/s10067-019-04762-4
2. Jenkins SN, Neyman KM, Veledar E, Chen SC. A pilot study evaluating the efficacy of botulinum toxin A in the treatment of Raynaud phenomenon. J Am Acad Dermatol. 2013 Nov 1;69(5):834-5.
3. Herrick AL. Evidence-based management of Raynaud's phenomenon. Ther Adv Musculoskelet Dis. 2017 Dec;9(12):317-329. doi: 10.1177/1759720X17740074. Epub 2017 Nov 20. PMID: 29201156; PMCID: PMC5700788.
4. Frantz C, Avouac J, Distler O, et al. Impaired quality of life in systemic sclerosis and patient perception of the disease: A large international survey. Semin Arthritis Rheum. 2016;46(1):115-123. doi:10.1016/j.semarthrit.2016.02.005
5. Neumeister MW. Botulinum toxin type A in the treatment of Raynaud's phenomenon. J Hand Surg. 2010;35(12):2085–92. doi: 10.1016/j. jhsa.2010.09.019.
6. Neumeister MW, Chambers CB, Herron MS, Webb K, Wietfeldt J, Gillespie JN, et al. Botox therapy for ischemic digits. Plast Reconstr Surg. 2009;124(1):191–201. doi: 10.1097/PRS.0b013e3181a80576.
7. Sycha T, Graninger M, Auff E, Schnider P. Botulinum toxin in the treatment of Raynaud's phenomenon: a pilot study. European journal of clinical investigation. 2004;34(4):312–3. doi: 10.1111/j.1365-2362.2004.01324.x.

AUTHOR CORRESPONDENCE

Ruth Ann Vleugels MD MPH MBA rvleugels@bwh.harvard.edu
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