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Despite many effective therapeutics, health-related quality of life in RA remains low. Patients describe impacts of their disease in differing terms than health-care providers, stressing importance of pain, fatigue, poor sleep, and restrictions in work and social participation. Patient-reported outcomes (PROs) across the phase 3 randomized controlled trials (RCTs) in RA with the JAK inhibitors (JAKis) are summarized. Patient populations, whether conventional synthetic disease modifying anti-rheumatic drug incomplete responders (csDMARD-IR) or biologic DMARD incomplete responders (bDMARD-IR) or csDMARD-naive, report differing baseline scores and placebo responses, generally lower in more treatment experienced patients. Improvements with all the approved JAKis in RA occur rapidly and are often maximal by 12–14 weeks, continuing thereafter. The rapidity of benefit reported by patients and convenience of oral administration often lead to increased adherence. A broad variety of PROs utilized in the RA RCTs with the JAKis confirm the clinical meaningfulness of their efficacy across treatment-experienced and naive populations. A majority of patients report statistically significant as well as clinically meaningful (≥ minimum clinically important differences, MCID) improvements, with numbers needed to treat (NNTs) ≤ 10 and scores ≥ normative values at endpoint, despite ≤ 12% reporting such scores at baseline.

Patient-reported outcomes and realistic clinical endpoints for JAK inhibitors in rheumatoid arthritis