N/A
Completed N=7,807
Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.
Arthritis Rheumatoid
Source: ClinicalTrials.gov NCT04721821 ↗
Enrolled (actual)
7,807
Serious AEs
—
Results posted
Apr 2024
Primary outcomePrimary: Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall — 129; 140 Participants
Summary
This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall |
129; 140 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
66; 48 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy |
166; 154 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy |
59; 68 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy |
82; 82 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall |
104; 127 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
44; 48 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy |
123; 129 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy |
40; 52 | — |
| PRIMARY Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy |
57; 67 | — |
| SECONDARY Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall |
61; 71; 53; 61 | — |
| SECONDARY Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
29; 23; 23; 24 | — |
| SECONDARY Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy |
69; 78; 55; 56 | — |
| SECONDARY Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy |
28; 36; 20; 30 | — |
| SECONDARY Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy |
34; 41; 26; 23 | — |
| SECONDARY Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall |
-3.85; -3.98; -3.29; -4.39 | — |
| SECONDARY Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
-3.43; -2.66; -3.30; -2.31 | — |
| SECONDARY Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy |
-4.39; -4.36; -5.07; -3.49 | — |
| SECONDARY Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy |
-3.26; -3.66; -3.33; -4.39 | — |
| SECONDARY Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy |
-3.92; -4.53; -3.28; -4.29 | — |
| SECONDARY Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall |
138; 143; 114; 109; 73; 87 | — |
| SECONDARY Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
63; 56; 46; 43; 38; 25 | — |
| SECONDARY Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy |
137; 151; 111; 107; 90; 85 | — |
| SECONDARY Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy |
66; 66; 42; 33; 36; 37 | — |
| SECONDARY Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy |
91; 91; 65; 57; 47; 39 | — |
| SECONDARY Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall |
54; 64; 44; 40 | — |
| SECONDARY Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
24; 20; 14; 16 | — |
| SECONDARY Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy |
62; 56; 39; 45 | — |
| SECONDARY Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy |
23; 32; 12; 17 | — |
| SECONDARY Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy |
36; 34; 24; 24 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall |
1.02; 1.06; 0.98; 1.05 | — |
| SECONDARY HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
1.05; 1.10; 1.06; 1.04 | — |
| SECONDARY HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy |
0.92; 0.88; 0.95; 0.98 | — |
| SECONDARY HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy |
0.98; 1.00; 1.01; 0.99 | — |
| SECONDARY HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy |
1.04; 1.10; 0.99; 1.04 | — |
| SECONDARY Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall |
197; 213; 174; 135 | — |
| SECONDARY Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
94; 82; 73; 75 | — |
| SECONDARY Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy |
202; 197; 129; 143 | — |
| SECONDARY Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy |
97; 95; 62; 62 | — |
| SECONDARY Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy |
121; 131; 94; 86 | — |
| SECONDARY Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall |
0.51; 0.53; 0.52; 0.53 | — |
| SECONDARY mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
0.55; 0.56; 0.57; 0.55 | — |
| SECONDARY mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy |
0.48; 0.44; 0.48; 0.49 | — |
| SECONDARY mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy |
0.50; 0.50; 0.53; 0.49 | — |
| SECONDARY mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy |
0.51; 0.56; 0.51; 0.53 | — |
| SECONDARY Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall |
43.61; 44.33; 43.22; 43.45 | — |
| SECONDARY Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
43.99; 44.89; 46.91; 44.21 | — |
| SECONDARY Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy |
42.70; 41.80; 42.74; 42.87 | — |
| SECONDARY Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy |
43.56; 42.97; 46.11; 41.82 | — |
| SECONDARY Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy |
43.62; 44.30; 43.13; 44.62 | — |
| SECONDARY Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall |
98; 102; 79; 79 | — |
| SECONDARY Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
43; 42; 30; 27 | — |
| SECONDARY Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy |
107; 96; 73; 71 | — |
| SECONDARY Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy |
44; 40; 28; 25 | — |
| SECONDARY Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy |
62; 56; 39; 36 | — |
| SECONDARY Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall |
46.23; 48.52; 46.75; 46.93 | — |
| SECONDARY Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
48.31; 45.40; 48.51; 48.64 | — |
| SECONDARY Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy |
46.25; 44.79; 46.20; 46.52 | — |
| SECONDARY Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy |
47.11; 48.74; 48.90; 47.01 | — |
| SECONDARY Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy |
45.06; 48.02; 46.75; 47.62 | — |
| SECONDARY Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall |
1.39; 1.56; 1.39; 1.51 | — |
| SECONDARY Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy |
1.38; 1.48; 1.62; 1.41 | — |
| SECONDARY Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy |
1.51; 1.41; 1.49; 1.48 | — |
| SECONDARY Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy |
1.29; 1.28; 1.51; 1.53 | — |
| SECONDARY Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy |
1.41; 1.46; 1.39; 1.62 | — |
Eligibility Criteria
Inclusion Criteria
- RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
- Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
- Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit
Exclusion Criteria
- Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
Data sourced from ClinicalTrials.gov (NCT04721821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.