Mycophenolate Mofetil Treatment Reduces the Risk of Treatment Escalation Due to Vascular Complications in Limited Cutaneous Systemic Sclerosis: Emulation of a Target Trial From the Italian Rheumatology Society SPRING Registry.
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De Lorenzis Enrico, Natalello Gerlando, De Angelis Rossella, Verardi Lucrezia, Giuggioli Dilia, Bajocchi Gianluigi, Dagna Lorenzo, Bellando-Randone Silvia, Zanframundo Giovanni, Foti Rosario, Cacciapaglia Fabio, Cuomo Giovanna, Ariani Alarico, Rosato Edoardo, Lepri Gemma, Girelli Francesco, Riccieri Valeria, Zanatta Elisabetta, Cavazzana Ilaria, Ingegnoli Francesca, De Santis Maria, Murdaca Giuseppe, Abignano Giuseppina, Pettiti Giorgio, Rossa Alessandra Della, Caminiti Maurizio, Iuliano Annamaria, Ciano Giovanni, Beretta Lorenzo, Bagnato Gianluca, Lubrano Ennio, De Andres Maria Ilenia, Giollo Alessandro, Bruni Cosimo, Orlandi Martina, Fornaro Marco, Saracco Marta, Agnes Cecilia, Cerasuolo Pier Giacomo, Alonzi Gabriella, Cipolletta Edoardo, Lumetti Federica, Spinella Amelia, Magnani Luca, Campochiaro Corrado, De Luca Giacomo, Codullo Veronica, Visalli Elisa, Iandoli Carlo, Gigante Antonietta, Pellegrino Greta, Pigatto Erika, Lazzaroni Maria-Grazia, Franceschini Franco, Generali Elena, Mennillo Gianna, Barsotti Simone, Mariano Giuseppa Pagano, Furini Federica, Vultaggio Licia, Parisi Simone, Peroni Clara Lisa, Bianchi Gerolamo, Fusaro Enrico, Sebastiani Gian Domenico, Govoni Marcello, D'Angelo Salvatore, Cozzi Franco, Conti Fabrizio, Guiducci Serena, Doria Andrea, Salvarani Carlo, Iannone Florenzo, D'Agostino Maria Antonietta, Ferri Clodoveo, Matucci Cerinic Marco, Bosello Silvia Laura, SPRING Italian Registry Collaborators
Аннотация
METHODS: Patients with lcSSc enrolled in the Italian Systemic Sclerosis Progression Investigation registry were retrospectively evaluated. All patients treated with MMF were matched to patients not treated with MMF, which was based on a roll-entry time-dependent propensity score built on demographics, clinical features, and baseline treatment. The escalation of vasoactive or vasodilator treatment up to 60 months was defined as the introduction of iloprost, endothelin receptor antagonists, or phosphodiesterase-5 inhibitors on top of the ongoing treatment, because of uncontrolled or newly diagnosed vascular complications. A hazards Cox model was also adopted to quantify the association of MMF treatment with treatment escalation.
RESULTS: A total of 1,435 patients with lcSSc were evaluated, of whom 152 were prescribed MMF (17.1% male; mean age at lcSSc onset 48.7 ± 13.9 years, 54.6% anti-Scl70 positive). The prescription of MMF was more common in men and in anti-Scl70 positive, anticentromere negative patients with interstitial lung disease, myositis, and without a history of digital ulcers. After matching 107 patients with MMF-untreated controls, the overall incidence of vasoactive/vasodilator treatment escalation events related to digital ulcers over a median follow-up of 40.5 months (interquartile range 23.3-60.0) was 0.3 per 100 patient-years in the MMF-treated group and 5.4 per 100 patient-years in the matched control group, with a significant difference in treatment escalation-free survival between the two groups (hazard ratio 0.05, 95% confidence interval 0.01-0.38; P value = 0.004).
CONCLUSION: In patients with lcSSc, the introduction of MMF has reduced the need for escalation of vasoactive or vasodilator treatment, suggesting that it may also help to prevent vascular complications, which frequently affect patients with lcSSc.