Full Papers
Prevention and management of gastrointestinal side effects in patients with systemic sclerosis-interstitial lung disease receiving anti-fibrotic therapy: a modified Delphi consensus study
N. Del Papa1, P. Cipriani2, C. Galeone3, P. Mariani4, C. Ogliari5
Collaborator/s: P. Airò1, L. Beretta2, S.L. Bosello3, C. Campochiaro4, I. Cavazzana5, V. Codullo6, L. Dardani7, R. De Angelis8, G. De Luca9, M. De Santis10, A. Della Rossa11, M.G. Lazzaroni12, L. Magnani13, M. Orlandi14, A. Spinella15, B. Vigone16, E. Zanatta17, G. Zanframundo18
- Scleroderma Clinic, UOC Clinica Reumatologica, ASST G. Pini-CTO, Università degli Studi di Milano, Italy.
- Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy.
- Bicocca-Applied Statistics Center (B-ASC), Department of Economics, Management and Statistics, University of Milano-Bicocca, Milano, Italy. carlotta.galeone@unimib.it
- Bicocca-Applied Statistics Center (B-ASC), Department of Economics, Management and Statistics, University of Milano-Bicocca, Milano, Italy.
- IRCCS Ospedale Galeazzi-Sant’Ambrogio, Division of General Surgery, Department of Biomedical Science for Health, Università degli Studi di Milano, Italy.
- Spedali Civili di Brescia, Brescia, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
- Dipartimento di Scienze Geriatriche e Ortopediche, Università Cattolica del Sacro Cuore, Roma; UOC di Reumatologia ed Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Roma, Italy.
- IRCCS Ospedale San Raffaele, Milano, Italy
- SC Reumatologia e Immunologia Clinica, Spedali Civili di Brescia, Brescia, Italy; DSCS Università degli Studi di Brescia, Brescia, Italy
- Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
- UOC Reumatologia, Ausl IRCCS Reggio Emilia, Reggio Emilia, Italy
- Clinica Reumatologica, Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Ancona, Italy
- Università Vita-Salute San Raffaele; Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare, IRCCS Ospedale San Raffaele, Milan, Italy
- IRCCS Humanitas Research Hospital, Rozzano; Humanitas University, Pieve Emanuele, Milan, Italy
- Azienda Ospedaliero Universitaria Pisana, Pisa, Italy
- Reumatologia e Immunologia Clinica, ASST Spedali Civili di Brescia, ERN ReConnet; Università degli Studi di Brescia, Brescia, Italy
- UOC medicina interna ad indirizzo reumatologico, AUSL Bologna, Bologna, Italy
- Department of Medical and Surgical Sciences for Children and Adults, Università degli Studi di Modena e Reggio Emilia, Modena, Italy
- Azienda Ospedaliera-Universitaria, Policlinico di Modena, Modena, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
- Università degli Studi di Padova, Padova, Italy
- Department of Internal Medicine and Therapeutics, Università di Pavia, Pavia, Italy; Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
SSc-ILD Study Group
CER19628
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PMID: 41810839 [PubMed]
Received: 19/12/2025
Accepted : 17/02/2026
In Press: 10/03/2026
Abstract
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.
