Display options
Cite
Shenavandeh S, Sepaskhah M, Dehghani S, et al. A 4-week comparison of capillaroscopy changes, healing effect, and cost-effectiveness of botulinum toxin-A vs prostaglandin analog infusion in refractory digital ulcers in systemic sclerosis. Clin Rheumatol. 2021;41(1):95-104doi: 10.1007/s10067-021-05900-7.
Shenavandeh, S., Sepaskhah, M., Dehghani, S., & Nazarinia, M. (2022). A 4-week comparison of capillaroscopy changes, healing effect, and cost-effectiveness of botulinum toxin-A vs prostaglandin analog infusion in refractory digital ulcers in systemic sclerosis. Clinical rheumatology, 41(1), 95-104. https://doi.org/10.1007/s10067-021-05900-7
Shenavandeh, Saeedeh, et al. "A 4-week comparison of capillaroscopy changes, healing effect, and cost-effectiveness of botulinum toxin-A vs prostaglandin analog infusion in refractory digital ulcers in systemic sclerosis." Clinical rheumatology vol. 41,1 (2022): 95-104. doi: https://doi.org/10.1007/s10067-021-05900-7
Shenavandeh S, Sepaskhah M, Dehghani S, Nazarinia M. A 4-week comparison of capillaroscopy changes, healing effect, and cost-effectiveness of botulinum toxin-A vs prostaglandin analog infusion in refractory digital ulcers in systemic sclerosis. Clin Rheumatol. 2022 Jan;41(1):95-104. doi: 10.1007/s10067-021-05900-7. Epub 2021 Sep 01. PMID: 34471968; PMCID: PMC8409478.
Copy Download .nbib Format: NLM
Share it on

Clin Rheumatol. 2022 Jan;41(1):95-104. doi: 10.1007/s10067-021-05900-7. Epub 2021 Sep 01.

A 4-week comparison of capillaroscopy changes, healing effect, and cost-effectiveness of botulinum toxin-A vs prostaglandin analog infusion in refractory digital ulcers in systemic sclerosis.

Clinical rheumatology

Saeedeh Shenavandeh, Mozhdeh Sepaskhah, Sanaz Dehghani, MohammadAli Nazarinia

Affiliations

  1. Department of Internal Medicine, Division of Rheumatology, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran. [email protected].
  2. Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
  3. Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
  4. Department of Internal Medicine, Division of Rheumatology, Namazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.

PMID: 34471968 PMCID: PMC8409478 DOI: 10.1007/s10067-021-05900-7

Abstract

INTRODUCTION: Systemic sclerosis (SSc) is a systemic multi-organ disease. Raynaud's phenomenon (RP) and digital ulcers (DUs) in SSc patients can be resistant to usual treatments. We studied the clinical benefits, capillaroscopy changes, and cost-effectiveness of local injection of botulinum toxin-A (BTX-A) and intravenous prostaglandin analogs (iloprost/alprostadil) in patients with SSc with resistant DUs.

METHOD: In a clinical trial study, we evaluated 26 patients fulfilling the ACR/EULAR SSc criteria with resistant DUs. Visual analog scale of pain and RP, skin color and type of ulcers, and capillaroscopy were assessed before and 1 month after treatment. In the first group, 20 units of BTX-A was injected at the base of each involved fingers by a dermatologist. In the second group, 20 µg iloprost or 60 µg alprostadil was infused daily. The cost of these treatments was compared.

RESULT: In 26 patients (43 fingers), there were 16 patients (22 fingers) in the BTX-A and 10 patients (21 fingers) in the prostaglandin group. In 95.5% of the BTX-A and 90.5% of the prostaglandin group, the ulcers were healed. In both groups, a significant decrease in pain was seen (p < 0.0001). Capillaroscopy patterns in both groups were not changed although the microhemorrhages disappeared significantly (p value: BTX-A: 0.03 and prostaglandin: 0.002). The cost was significantly lower in the BTX-A injection group (p < 0.0001).

CONCLUSION: Both BTX-A and prostaglandins helped in the healing and pain control of DUs. In capillaroscopy, microhemorrhages were significantly decreased in both groups. In the BTX-A group, the cost was significantly lower as an outpatient treatment and was more time-saving.

KEY MESSAGES: • BTX-A and prostaglandin analogs both contributed to the healing of digital tip ulcers and improving the pain • In capillaroscopy, microhemorrhages were significantly decreased or disappeared after both treatments • There was no significant side effect in both groups • Comparing both groups, in the BTX-A group, the cost was significantly lower when performed on an outpatient treatment and more time-saving.

© 2021. International League of Associations for Rheumatology (ILAR).

Keywords: Botulinum toxin; Capillaroscopy; Digital ulcer; Prostaglandin analogs; Systemic sclerosis

References

  1. Fredrick M (2016) Wigley MD aNAF, Ph.D. Raynaud’s phenomenon. The New England J Medicine - PubMed
  2. Polito P, Zanatta E, Felicetti M, Benvenuti F, Favaro M, Cozzi F et al (2020) Skin ulcers in systemic sclerosis correlation with clinical phenotype in a monocentric cohort from the north-east of Italy. Clin Exp Rheumatol 125(3):148–53 (38 Suppl) - PubMed
  3. Nihtyanova SI, Brough GM, Black CM, Denton CP (2008) Clinical burden of digital vasculopathy in limited and diffuse cutaneous systemic sclerosis. Ann Rheum Dis 67(1):120–123 - PubMed
  4. Hachulla E, Clerson P, Launay D, Lambert M, Morell-Dubois S, Queyrel V et al (2007) Natural history of ischemic digital ulcers in systemic sclerosis: single-center retrospective longitudinal study. J Rheumatol 34(12):2423–2430 - PubMed
  5. Chung L, Fiorentino D (2006) A pilot trial of treprostinil for the treatment and prevention of digital ulcers in patients with systemic sclerosis. J Am Acad Dermatol 54(5):880–882 - PubMed
  6. McHugh NJ, Csuka M, Watson H, Belcher G, Amadi A, Ring EF et al (1988) Infusion of iloprost, a prostacyclin analogue, for treatment of Raynaud’s phenomenon in systemic sclerosis. Ann Rheum Dis 47(1):43–47 - PubMed
  7. Ho M, Veale D, Eastmond C, Nuki G, Belch J (2000) Macrovascular disease and systemic sclerosis. Ann Rheum Dis 59(1):39–43 - PubMed
  8. Gardinali M, Pozzi MR, Bernareggi M, Montani N, Allevi E, Catena L et al (2001) Treatment of Raynaud’s phenomenon with intravenous prostaglandin E1alpha-cyclodextrin improves endothelial cell injury in systemic sclerosis. J Rheumatol 28(4):786–794 - PubMed
  9. Aoki KR (2001) Pharmacology and immunology of botulinum toxin serotypes. J Neurol 248(Suppl 1):3–10 - PubMed
  10. Fregene A, Ditmars D, Siddiqui A (2009) Botulinum toxin type A: a treatment option for digital ischemia in patients with Raynaud’s phenomenon. J Hand Surg Am 34(3):446–452 - PubMed
  11. Sato LT, Kayser C, Andrade LE (2009) Nailfold capillaroscopy abnormalities correlate with cutaneous and visceral involvement in systemic sclerosis patients. Acta Reumatol Port 34(2A):219–227 - PubMed
  12. Avouac JGL, Smith V, Toniolo E (2017) Sequential nailfold videocapillaroscopy examinations have responsiveness to detect organ progression in systemic sclerosis. Seminars in Arthritis and Rheumatism 47(1):86–94 - PubMed
  13. van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A et al (2013) 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis Rheum 65(11):2737–2747 - PubMed
  14. Ingegnoli F, Herrick AL, Schioppo T, Bartoli F, Ughi N, Pauling JD, et al (2020) Reporting items for capillaroscopy in clinical research on musculoskeletal diseases: a systematic review and international Delphi consensus. Rheumatology (Oxford). - PubMed
  15. Corrado A CG, Gaudio A, Foschino-Barbaro MP, Cantatore FP (2010) Nailfold capillaroscopic findings in systemic sclerosis related lung fibrosis and in idiopathic lung fibrosis. Joint Bone Spine. - PubMed
  16. Cutolo M, Sulli A, Pizzorni C, Accardo S (2000) Nailfold videocapillaroscopy assessment of microvascular damage in systemic sclerosis. J Rheumatol 27(1):155–160 - PubMed
  17. Smith V HAL, Ingegnoli F, Damjanov N, Angelis R D (2020) standardization of nailfold capillaroscopy for the assessment of the patients with Reynaud’s phenomenon and systemic sclerosis. Autoimmunity Reviews. - PubMed
  18. Lautenbach G, Dobrota R, Mihai C, Distler O, Calcagni M, Maurer B (2020) Evaluation of botulinum toxin A injections for the treatment of refractory chronic digital ulcers in patients with systemic sclerosis. Clin Exp Rheumatol 38 Suppl 125(3):154–60s - PubMed
  19. Motegi SI, Uehara A, Yamada K, Sekiguchi A, Fujiwara C, Toki S et al (2017) Efficacy of botulinum toxin B injection for Raynaud’s phenomenon and digital ulcers in patients with systemic sclerosis. Acta Derm Venereol 97(7):843–850 - PubMed
  20. Motegi S, Yamada K, Toki S, Uchiyama A, Kubota Y, Nakamura T et al (2016) Beneficial effect of botulinum toxin A on Raynaud’s phenomenon in Japanese patients with systemic sclerosis: a prospective, case series study. J Dermatol 43(1):56–62 - PubMed
  21. Tingey T, Shu J, Smuczek J, Pope J (2013) Meta-analysis of healing and prevention of digital ulcers in systemic sclerosis. Arthritis Care Res (Hoboken) 65(9):1460–1471 - PubMed
  22. Wigley FM, Wise RA, Seibold JR, McCloskey DA, Kujala G, Medsger TA Jr et al (1994) Intravenous iloprost infusion in patients with Raynaud phenomenon secondary to systemic sclerosis A multicenter, placebo-controlled, double-blind study. Ann Intern Med. 120(3):199–206 - PubMed
  23. Neumeister MW (2010) Botulinum toxin type A in the treatment of Raynaud’s phenomenon. J Hand Surg Am 35(12):2085–2092 - PubMed
  24. Al-Ghamdi AS AN, Joharji H, Al-Qahtani D, Alghamdi H (2015) Botulinum toxin: non cosmetic and off-label dermatological uses. J Dermatol Dermatolog Surg. - PubMed
  25. Schioppo T, Orenti A, Boracchi P, De Lucia O, Murgo A, Ingegnoli F (2018) Acute and chronic effects of two different intravenous iloprost regimens in systemic sclerosis: a pragmatic non-randomized trial. Rheumatology (Oxford) 57(8):1408–1416 - PubMed
  26. Valentina Cestelli AM, Marco Sebastiani, Emanuela Praino, Francesca Cannarile, Dilia Giuggioli, Clodoveo Ferri (2016) Effect of treatment with iloprost with or without bosentan on nailfold videocapillaroscopic alterations in patients with systemic sclerosis. Mod Rheumatol. - PubMed
  27. Trombetta AC, Pizzorni C, Ruaro B, Paolino S, Sulli A, Smith V et al (2016) Effects of longterm treatment with bosentan and iloprost on nailfold absolute capillary number, fingertip blood perfusion, and clinical status in systemic sclerosis. J Rheumatol 43(11):2033–2041 - PubMed
  28. Motegi SI, Sekiguchi A, Saito S, Ishibuchi H, Kishi C, Yasuda M et al (2018) Successful treatment of Raynaud’s phenomenon and digital ulcers in systemic sclerosis patients with botulinum toxin B injection: assessment of peripheral vascular disorder by angiography and dermoscopic image of nail fold capillary. J Dermatol 45(3):349–352 - PubMed

Publication Types

Grant support