Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)

Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/hour\]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 \[very well\] to 100 millimeter (mm) \[extremely bad\]). DAS28 less than or equal to (\<=) 3.2=low DA; greater than (\>) 3.2 to \<=5.1=moderate DA; \>5.1=high DA; \<2.6=remission.

Time frame: Month 12

Population: Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).

Time frame: Baseline, Month 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.

Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 \<=3.2= low DA; \>3.2 to \<=5.1= moderate DA; \>5.1=high DA; \<2.6=remission.

Time frame: Month 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.

Time frame: Month 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy.

Time frame: Month 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Correlation between BMQ concerns score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.

Time frame: Baseline

Population: BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics.

Correlation between BMQ necessity score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.

Time frame: Baseline

Population: BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics.

Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 \<=3.2= low DA; \>3.2 to \<=5.1= moderate DA; \>5.1=high DA; \<2.6=remission.

Time frame: Month 6, 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point.

Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.

Time frame: Month 6, 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at each specified time point.

Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]). DAS28 \<=3.2= low DA; \>3.2 to \<=5.1= moderate DA; \>5.1=high DA; \<2.6=remission.

Time frame: Month 6, 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point.

Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.

Time frame: Month 6, 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point.

BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.

Time frame: Month 6, 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable for each specified subscales.

BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.

Time frame: Baseline

Population: BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for each specified subscales.

BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).

Time frame: Baseline

Population: BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items.

BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).

Time frame: Month 6, 12

Population: FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.