Background/Purpose: Gastrointestinal (GI) involvement is a common manifestation of systemic sclerosis (SSc) and a frequent side-effect of drugs used to treat SSc. In the SENSCIS trial, nintedanib reduced the rate of decline in forced vital capacity (FVC) in patients with SSc-associated interstitial lung disease (SSc-ILD), with an adverse event profile characterized predominantly by GI events. We assessed the severity and impact of GI symptoms on quality of life in patients treated with nintedanib in the open-label extension of the SENSCIS trial, SENSCIS-ON.

Methods: Patients with SSc-ILD who completed the SENSCIS trial or a drug–drug interaction (DDI) study of nintedanib and oral contraceptive were eligible to enter SENSCIS-ON. Patients who received nintedanib in SENSCIS (up to 100 weeks) and continued nintedanib in SENSCIS-ON comprised the “continued nintedanib” group. Patients who received placebo in SENSCIS and initiated nintedanib in SENSCIS-ON, or who received nintedanib for a short time in the DDI study, comprised the “initiated nintedanib” group. There was a maximum interruption of 12 weeks between the last dose of nintedanib in SENSCIS and the first dose in SENSCIS-ON. We assessed changes in scores on the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT) questionnaire v2.0 from baseline to week 52. This questionnaire comprises 7 scales measuring the severity and impact of GI symptoms: reflux, distension or bloating, fecal soilage, diarrhea, constipation, emotional well-being, social functioning. Each scale is scored from 0 to 3 except for the diarrhea scale (0 to 2) and constipation scale (0 to 2.5). The total score, derived as the mean of the scores for the scales except constipation, ranges from 0 to 2.83, with higher scores indicating worse symptoms.

Results: The “continued nintedanib” group comprised 197 patients and the “initiated nintedanib” group comprised 247 patients (231 from SENSCIS). Of these, 178 and 218 patients, respectively, provided a total UCLA SCTC GIT score at baseline. At baseline, mean (SD) total scores were 0.33 (0.33) and 0.33 (0.34) in the continued nintedanib and initiated nintedanib groups, respectively. Mean (SD) scores on the 7 scales ranged from 0.16 (0.52) to 0.70 (0.73) in the continued nintedanib group and from 0.13 (0.43) to 0.64 (0.68) in the initiated nintedanib group. Increases (worsening) in scores were observed in both groups from baseline to week 52, except for on the constipation scale (Figure). Based on the total score, between baseline and week 52, the proportion of patients with moderate or severe or very severe GI symptoms increased, but 45.7% and 39.7% of patients in the continued nintedanib and initiated nintedanib groups, respectively, had no or mild GI symptoms at week 52 (Table 1). Changes in the diarrhea scale score are shown in Table 2.

Conclusion: In the SENSCIS-ON trial, the majority of patients with SSc-ILD treated with nintedanib had no or mild GI symptoms at baseline. A small worsening in GI symptoms was observed over 52 weeks. Diarrhea had the greatest impact, reflecting the adverse event profile of nintedanib. Recommendations for the management of diarrhea in patients treated with nintedanib should be implemented in clinical practice.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/severity-and-impact-of-gastrointestinal-symptoms-in-patients-with-ssc-ild-treated-with-nintedanib-data-from-senscis-on/