Patient-reported Symptoms May Reflect Changes in SSc Activity, Study Suggests

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Patient-reported symptoms

Patient-reported symptoms — specifically those related to blood vessel, skin, and lung function — may be used to indicate changes in disease activity in people with systemic sclerosis (SSc), an Australian study suggests.

The study, “Can patient-reported symptoms be used to measure disease activity in systemic sclerosis?,” was published in the journal Arthritis Care & Research.

Systemic sclerosis, or scleroderma, affects multiple systems and almost any organ in the body, causing progressive, widespread fibrosis (tissue scarring). Besides its hallmark affected organ, the skin, the disease commonly affects the heart and blood vessels, the lungs, stomach, and kidneys.

Quantifying disease activity in scleroderma patients remains challenging because of its complex cause and development, the episodic nature of certain symptoms, and the lack of validated biomarkers or objective measures for the various aspects of disease activity.

To overcome the lack of objective measures to determine disease activity in all organs, patient-reported symptoms and assessments have been included in disease activity indices and outcome measures. Other situations where patient-reported symptoms could be relevant for the assessment of scleroderma are at a first clinical visit or when scheduled tests have been missed.

However, the relationship between patient-reported symptoms and objective features of scleroderma disease activity remains unclear.

Researchers set out to evaluate the association between patient-reported symptoms — specifically Raynaud’s phenomenon, skin manifestations, and shortness of breath — and objective measures of scleroderma disease activity.

Raynaud’s phenomenon (a condition that affects the blood vessels in the fingers and toes, making them numb, prickly, and frigid in response to cold temperatures or stress) and skin manifestations are among the most common and early symptoms of scleroderma. Shortness of breath is considered an important predictor of fibrosis-associated lung diseases and death from heart-associated conditions.

These symptoms have been previously suggested to correlate, at least to some degree, with objective measures of disease activity.

The team analyzed data collected from 1,636 adults with scleroderma enrolled in the Australian Scleroderma Cohort Study (ASCS), a prospective multi-center study assessing risk and prognostic factors in scleroderma.

Participants had a mean age of 57.37 years, 86% of them were women, and 25.73% had diffuse cutaneous scleroderma. At enrollment, they had a mean disease duration of 11.07 years, and were followed for a mean 3.99 years.

At each annual visit, they were asked if their Raynaud’s phenomenon, skin manifestations, or shortness of breath had been worse in the preceding month, and objective features of disease activity were used to assess the corresponding affected organ.

The research team evaluated the presence of digital ulcers and new digital pitting scars (blood-vessel related); changes in modified Rodnan skin score (mRSS), which measures skin thickening; new areas of skin scarring, new-onset joint contractures (skin-related), plus changes in lung function tests, new-onset interstitial lung disease (ILD), and new-onset pulmonary arterial hypertension (PAH) (lung-related).

Results showed a significant association between patient-reported worsening Raynaud’s phenomenon and the presence of digital ulcers. In addition, patient-reported worsening skin manifestations were linked to increasing mRSS scores, while patient-reported worsening in shortness of breath was associated with deterioration of lung function tests, new-onset ILD, and new-onset PAH.

Patients with worse Raynaud’s phenomenon symptoms within the preceding month were 53% more likely to have digital ulcers, while those reporting worsening skin manifestations had twice the risk of skin disease.

“Despite the multi-factorial nature of the patient experience of breathlessness, there remains a strong relationship between patient-reported worsening breathlessness and clinically meaningful change in [lung function tests] and pulmonary dysfunction in SSc,” the researchers said.

The most noticeable association in lung-related function was found in patients reporting increased shortness of breath in the preceding month, who were five times more likely to be diagnosed with PAH.

Supported by these findings, the team believes that “patient-reported symptoms are associated with clinically meaningful changes in disease activity in SSc patients,” and “when objective measures of change in disease status are unavailable, patient-reported symptoms could be used to indicate a change in SSc disease activity.”

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