Prevention and management of gastrointestinal side effects in patients with systemic sclerosis-interstitial lung disease receiving anti-fibrotic therapy: a modified Delphi consensus study

Objectives: Interstitial lung disease (ILD) is one of the most common manifestations of systemic sclerosis (SSc), with most patients requiring treatment with immunosuppressive or anti-fibrotic agents to control ILD progression. Since gastrointestinal (GI) tract complications are widespread in this patient setting, we focused on their prevention and management. Methods: We conducted a modified Delphi study following best practices for consensus studies. We involved 20 expert rheumatologists from 8 Italian regions in two online rounds conducted between April and September 2024. Results: An agreement of at least two-thirds of panellists was achieved on most topics explored, including the need for a preliminary evaluation of GI status in patients with SSc-ILD undergoing anti-fibrotic therapy (100% agreement), taking into account the presence of pre-existing diarrhoea (100%), weight loss (95%) and nausea/loss of appetite (100%), the definition of specific tests and exams for these conditions, the need of informing patients on potential GI complications (100%) and nutritional preventive advice (85%), and the monitoring of GI status during anti-fibrotic therapy (100%), at 3-month intervals (75%). Further, dose-reduction of anti-fibrotic therapy and, if needed, temporary discontinuation, was agreed in presence of side effects including diarrhoea (95%) or weight loss (85%). In the presence of nausea or loss of appetite, dose-reduction was also agreed, with no immediate need for drug discontinuation (90%). Conclusions: This study provided a detailed list of expert-based recommendations to guide everyday clinical practice of SSc-ILD, though prospective validation is needed to confirm their effectiveness in preventing and managing GI side effects.