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Background: The gastrointestinal (GI) tract is frequently affected in systemic sclerosis (SSc), leading to considerable morbidity and even mortality. While important progress has been made in the last years regarding treatment of SSc, there is no disease-modifying treatment available for SSc-related GI involvement.
Objectives: We aimed to identify, in an observational cohort study of real-life patients with SSc, an association between immunosuppressive therapy and the severity of GI symptoms, measured by the University of California at Los Angeles / Scleroderma Clinical Trial Consortium Gastro-Intestinal Tract instrument 2.0 (UCLA GIT 2.0).
Methods: We selected patients from our EUSTAR centre who met the 2013 ACR/EULAR classification criteria for SSc and had at least two visits with completed UCLA GIT 2.0 questionnaires, with an interval of 12±3 months between visits. We defined the first visit with a completed UCLA GIT 2.0 questionnaire as baseline visit. Immunosuppressive therapy was defined as exposure for at least 6 months between the two visits to at least one of the following drugs, regardless of indication: mycophenolate mofetil (MMF), cyclophosphamide, methotrexate, azathioprine, leflunomide, glucocorticoids (>10mg/d prednisone-equivalent), rituximab, tocilizumab, and abatacept. The study outcome was the UCLA GIT 2.0 score at the follow-up visit. We performed multivariable linear regression with this outcome as dependent variable and immunosuppressive therapy during follow-up, immunosuppressive therapy before baseline, baseline UCLA GIT 2.0 score and several baseline parameters selected by clinical judgment as potentially influencing GI symptoms, as independent variables. Multiple imputation was implemented to handle missing values.
Results: We included 209 patients. Baseline characteristics were: 82.3% female, median (IQR) age 59.0 (48.6, 68.2) years, median disease duration 6.0 (2.7, 12.5) years, 40 (19.1%) diffuse cutaneous SSc, median baseline UCLA GIT 2.0 score 0.19 (0.06, 0.43). Of these, 71 patients were exposed to immunosuppressive therapy during the observation period: 27/71 methotrexate, 1/71 cyclophosphamide, 17/71 MMF, 3/71 leflunomide, 3/71 azathioprine, 6/71 glucocorticoids >10mg/d, 16/34 rituximab, 18/34 tocilizumab. Patients on immunosuppressive therapy during the observation period had, compared to patients without such treatment, overall more severe SSc, higher prevalence of treatment with proton pump inhibitors, similar UCLA GIT 2.0 scores at baseline and at follow up and tendentially less severe GI symptoms at baseline and follow-up by medical history. In multivariable linear regression, immunosuppressive therapy, lower body mass index, longer disease duration and lower baseline UCLA GIT 2.0 score were significantly associated with lower (better) UCLA GIT 2.0 scores at follow-up (
| Predictors of UCLA GIT 2.0 score at follow-up | Estimates | 95% CI | p |
|---|---|---|---|
| Age | 0.002 | -0.001 – 0.006 | 0.136 |
| Sex [male] | -0.056 | -0.172 – 0.061 | 0.347 |
| Disease duration | -0.005 | -0.009 – -0.000 | 0.030 |
| Body mass index | 0.014 | 0.002 – 0.025 | 0.017 |
| UCLA GIT 2.0 total score baseline | 0.690 | 0.571 – 0.809 | <0.001 |
| Immunosuppressive therapy during observation period | -0.119 | -0.228 – -0.010 | 0.032 |
| Immunosuppressive therapy before baseline | 0.080 | -0.032 – 0.192 | 0.160 |
| Modified Rodnan Skin Score | -0.001 | -0.008 – 0.007 | 0.860 |
| Forced vital capacity | -0.001 | -0.004 – 0.001 | 0.302 |
| Erythrocyte sedimentation rate | 0.003 | -0.001 – 0.006 | 0.116 |
| Proton pump inhibitors | -0.034 | -0.120 – 0.052 | 0.435 |
| (Intercept) | -0.120 | -0.531 – 0.291 | 0.566 |
Baseline factors associated with the total UCLA GIT 2.0 score at the end of the observation period. Multiple linear regression model with imputation for missing variables. N=209 patients
Conclusion: Immunosuppressive treatment was associated with lower UCLA GIT 2.0 scores, which suggests potential effects of immunosuppressants on GI manifestations in patients with SSc. These results need verification in additional studies and randomised controlled clinical trials.
REFERENCES:
[1]Khanna D et al. Arthritis Rheum, 2009; 61 : 1257-63.
Disclosure of Interests: Lea Stamm: None declared, Alexandru Garaiman: None declared, Norina Zampatti: None declared, Mike O. Becker Speakers bureau: Mepha, MSD, Novartis, GSK, Bayer and Vifor, Consultant of: Mepha, MSD, Novartis, GSK, Bayer and Vifor, Grant/research support from: Mepha, MSD, Novartis, GSK, Bayer and Vifor, Cosimo Bruni Speakers bureau: Actelion, Eli-Lilly, Boehringer-Ingelheim, Grant/research support from: Abbvie, EUSTAR, Gruppo Italiano Lotta alla Sclerodermia (GILS), SCTC, Rucsandra Dobrota Consultant of: Boehringer-Ingelheim, Grant/research support from: Iten-Kohaut Foundation, Muriel Elhai: None declared, Sherif Ismail Grant/research support from: EULAR scientific training grant for young fellows 2021, Suzana Jordan: None declared, Aurora Tatu: None declared, Oliver Distler Speakers bureau: Bayer, Boehringer Ingelheim, Janssen, Medscape, Consultant of: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, 4P Science, Galapagos, Glenmark, Horizon, Inventiva, Kymera, Lupin, Miltenyi Biotec, Mitsubishi Tanabe, MSD, Novartis, Prometheus, Roivant, Sanofi and Topadur, Grant/research support from: Kymera, Mitsubishi Tanabe, Boehringer Ingelheim, Carina Mihai Speakers bureau: Boehringer-Ingelheim, Mepha, MED Talks Switzerland, Consultant of: Boehringer-Ingelheim, Janssen, Grant/research support from: Boehringer-Ingelheim, Janssen, Roche.