Study design, outcome measures, and data abstraction

This study was a restrospective case series reporting our Center’s experience with linaclotide in SSc patients with severe GI complications. All patients were required to report symptoms of constipation (e.g. ≤ 3 bowel movements per week), despite the use of at least one other medication (e.g. polyethelene glycol, senna). Symptom response was defined by an improvement in the number of bowel movements, stool consistency, ease of evacuation, and/or associated symptoms (abdominal pain, distention, bloating, etc.) in the absence of intolerable side effects documented in the medical record, and/or the continuation of treatment for at least 12 months.

All included patients were required to have at least one follow-up visit or telephone note documenting compliance with the medication for at least two weeks. Patients were excluded from the analysis if they did not take the prescribed the medication, or lacked follow-up at least two weeks after the index visit. Patients still receiving treatment or who stopped the medication due to cost concerns were included as responders regardless of length of treatment if they had documentation of symptom improvement. Patients were classified as non-responders if they stopped the medication within the first 12 months due to lack of response or intolerable side effects. As clinical practice varied on dosing, we also classified patients as high or low dose regimens for comparison. High dose linaclotide was defined by a dose of greater than 145 mcg daily. Low dose linaclotide included patients with 145 mcg daily dosing or less, including as needed regimens.

Once identified as having taken linaclotide, the patients’ charts were reviewed to screen for inclusion and exclusion criteria and to collect additional details relevant to the study. The date of first linaclotide prescription was designated as the index visit. All subsequent outpatient notes and telephone calls were reviewed for documentation of medication adherence or discontinuation, dose modification, response to treatment, and reported adverse effects. Data abstraction was completed using a standardized data abstraction sheet so that all charts were systematically reviewed for the same information.

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