Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Tumor Necrosis Factor Inhibitors

Tofacitinib

Janus Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

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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.

Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

Comparative Effectiveness of Tumor Necrosis Factor (TNF) Inhibitors and Tofacitinib, Overall, by Line of Therapy and by Combination Therapy

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to (\<=)10 in participants with moderate or high disease activity CDAI greater than (\>) 10 at baseline. Propensity score method was used for analysis of the outcome measure.

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.

CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.

mACR 20/50/70 response was defined as response greater than or equal to( \>=) 20 percent (%), 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the modified Health Assessment Questionnaire (mHAQ) \[scored from 0 to 3, higher scores indicated worsening of function\]. Propensity score method was used for analysis of the outcome measure.

mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.

DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.

DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.

HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.

MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.

mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.

Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.

Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.

Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.

Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.

Pfizer

Minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not collected and reported.

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.

Tofacitinib (6 Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.

TNFis (6 Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

Tofacitinib (12 Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

TNFis (12 Month Follow-up)

Tofacitinib (6-Month Follow-up)

TNFis (6-Month Follow-up)

Tofacitinib (12-Month Follow-up)

TNFis (12-Month Follow-up)

Total

"Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Analysis population included all eligible participants whose data were observed in this study.

Pfizer ClinicalTrials.gov Call Center

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.

Tofacitinib Overall (6-Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.

TNFis Overall (6-Month Follow-up)

Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.

Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.

Tofacitinib Monotherapy (6-Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.

Tofacitinib Combination Therapy (6-Month Follow-up)

Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity CDAI \>10 at baseline.

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.

TNFis Monotherapy (6-Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.

TNFis Combination Therapy (6-Month Follow-up)

Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy

TNFis Combination Therapy (6 Month Follow-up)

Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

Tofacitinib Overall (12-Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

TNFis Overall (12-Month Follow-up)

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

Tofacitinib Monotherapy (12-Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.

Tofacitinib Combination Therapy (12-Month Follow-up)

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

TNFis Monotherapy (12-Month Follow-up)

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

TNFis Combination Therapy (12-Month Follow-up)

Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy

TNFis Combination Therapy (12- Month Follow-up)

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

Tofacitinib Combination Therapy (12-Month Follow-up

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm

TNFis Combination Therapy (12 Month Follow-up)

Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

TNFis Overall (6 Month Follow-up)

Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy

Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy

Month 6 follow-up visit analysis: mACR 20

Month 6 follow-up visit analysis: mACR 50

Month 6 follow-up visit analysis: mACR 70

Month 12 follow-up visit analysis: mACR 20

Month 12 follow-up visit analysis: mACR 50

Month 12 follow-up visit analysis: mACR 70

mACR 20

mACR 50

mACR 70

Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall

Tofacitinib Combination Therapy (6-Month Follow-up))

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy

Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy

Tofacitinib Monotherapy (12 Month Follow-up)

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy

Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.

Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy

Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR \>3.2 at baseline.

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

Spots Global Cancer Trial Database for Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

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