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Additional file 1: Supplementary Table 1; Supplementary figures 1–2. Mean change from baseline in PRO domain scores at month 3 across treatment groups; changes from baseline in MOS-SS domains scores up to month 12; changes from baseline in SF-36 domain scores up to month 12.

Ethical review boards and study centers. (DOCX 34 kb)

Trimmed analysis of data for mTSS change from baseline at month 6 and month 12 in ORAL Scan and ORAL Start. The table provides least squares mean changes from baseline at month 6 and month 12, and treatment differences versus comparator with 95 % CIs for both the ORAL Scan and ORAL Start studies. (DOCX 15 kb)

Ethical review boards and study centers. (DOCX 34 kb)

Rates of reporting improvements meeting or exceeding US normative Short Form-36 (SF-36) scores, in comparison with placebo. (DOC 120 kb)

Numbers needed to treat for ACR 20/50/70 (a), Disease Activity Score based on C reactive protein and 28 tender joint count and 28 swollen joint count (DAS28-3(CRP)) improvement of 1.2 and 0.6 (b), HAQ-DI ≤0.5 (c), patient global assessment (d), and pain (e) ≥ the minimal clinically important difference (MCID) for tofacitinib 5 and 10 mg twice daily (BID). (DOC 146 kb)

Rates of reporting normative values for the Health Assessment Questionnaire-Disability Index (HAQ-DI) (≤0.5) per visit; * p ≤0.05, ** p ≤0.01, *** p ≤0.0001 versus placebo. BID twice daily, CI confidence interval on the estimate of the rate. (DOCX 12 kb)

Rates reports of improvements meeting or exceeding clinically meaningful and normative values in both a patient- reported outcome (PRO) and DAS28-(CRP) at month 3; * p â ¤0.05, ** p â ¤0.01, *** p â ¤0.0001 versus placebo. BID twice daily, DAS28-3(CRP) Disease Activity Score based on C reactive protein and 28 tender joint count and 28 swollen joint count, HAQ-DI Health Assessment Questionnaire-Disability Index, NNT number needed to treat versus placebo, MCID minimally clinically important difference. (DOCX 15 kb)

Rates reports of improvements meeting or exceeding clinically meaningful and normative values in both a patient- reported outcome (PRO) and DAS28-(CRP) at month 3; * p â ¤0.05, ** p â ¤0.01, *** p â ¤0.0001 versus placebo. BID twice daily, DAS28-3(CRP) Disease Activity Score based on C reactive protein and 28 tender joint count and 28 swollen joint count, HAQ-DI Health Assessment Questionnaire-Disability Index, NNT number needed to treat versus placebo, MCID minimally clinically important difference. (DOCX 15 kb)

Ethical review boards and study centers. (DOCX 35 kb)

Rates of reporting normative values for the Health Assessment Questionnaire-Disability Index (HAQ-DI) (≤0.5) per visit; * p ≤0.05, ** p ≤0.01, *** p ≤0.0001 versus placebo. BID twice daily, CI confidence interval on the estimate of the rate. (DOCX 12 kb)

Baseline and changes from baseline by visit prior to month 3 for patient-reported outcome measures; *p < 0.01; **p < 0.001; ***p < 0.0001 vs placebo. an = 237; bn = 240; cn = 237; dn = 238; en = 231; fn = 241; gn = 243. BID twice daily, HAQ-DI Health Assessment Questionnaire-Disability Index, LSM least squares mean, Pain Patient Global Assessment of Pain, PtGA Patient Global Assessment of Disease Activity, SD standard deviation, SE standard error. (DOCX 13 kb)