Trial Outcomes & Findings for Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis (NCT NCT01474876)

NCT ID: NCT01474876

Last Updated: 2015-07-08

Results Overview

The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.

• Recruitment status: COMPLETED
• Target enrollment: 566 participants
• Primary outcome timeframe: Baseline (Visit 0) to 12 months
• Results posted on: 2015-07-08

Participant Flow

A total of 566 participants were enrolled, and 11 participants were lost to follow-up after the baseline visit. According to the pre-specified analysis strategy in the statistical analysis plan, these participants were excluded from the full analysis set, which consisted of 555 participants.

Participant milestones

Measure	Ankylosing Spondylitis Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis	Disease State Unknown For one participant, information regarding the underlying disease was not available
Overall Study STARTED	403	151	1
Overall Study COMPLETED	337	128	1
Overall Study NOT COMPLETED	66	23	0

Reasons for withdrawal

Measure	Ankylosing Spondylitis Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis	Disease State Unknown For one participant, information regarding the underlying disease was not available
Overall Study Adverse Event	11	5	0
Overall Study Serious Adverse Event	2	3	0
Overall Study Lost to Follow-up	5	4	0
Overall Study Investigator's decision	28	6	0
Overall Study Patient's request	19	5	0
Overall Study Investigator's decision and pt request	1	0	0

Baseline Characteristics

Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Ankylosing Spondylitis n=403 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=151 Participants Participants with a diagnosis of psoriatic arthritis	Disease State Unknown n=1 Participants For one participant, information regarding the underlying disease was not available	Total n=555 Participants Total of all reporting groups
Age, Continuous	44.0 years STANDARD_DEVIATION 12.8 • n=5 Participants	49.7 years STANDARD_DEVIATION 12.1 • n=7 Participants	40 years STANDARD_DEVIATION NA • n=5 Participants	45.6 years STANDARD_DEVIATION 12.9 • n=4 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	65 Participants n=7 Participants	0 Participants n=5 Participants	174 Participants n=4 Participants
Sex: Female, Male Male	294 Participants n=5 Participants	86 Participants n=7 Participants	1 Participants n=5 Participants	381 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with active axial symptoms (a baseline value of the BASDAI \> 4).

The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.

Outcome measures

Measure	Ankylosing Spondylitis n=366 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=52 Participants Participants with a diagnosis of psoriatic arthritis
Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline	76.5 Percentage of participants Interval 71.8 to 80.8	73.1 Percentage of participants Interval 59.0 to 84.4

PRIMARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with peripheral symptoms (DAS28 \> 5.1 at baseline)

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Outcome measures

Measure	Ankylosing Spondylitis n=18 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=61 Participants Participants with a diagnosis of psoriatic arthritis
Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline	83.3 Percentage of participants Interval 58.6 to 96.4	83.6 Percentage of participants Interval 71.9 to 91.8

PRIMARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with active axial symptoms (a baseline value of BASDAI \> 4)

The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.

Outcome measures

Measure	Ankylosing Spondylitis n=361 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=52 Participants Participants with a diagnosis of psoriatic arthritis
Percentage of Participants With Active Axial Symptoms in Remission	34.3 Percentage of participants Interval 29.5 to 39.5	28.8 Percentage of participants Interval 17.1 to 33.1

PRIMARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with peripheral symptoms (DAS28 \> 5.1 at baseline)

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.

Outcome measures

Measure	Ankylosing Spondylitis n=18 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=61 Participants Participants with a diagnosis of psoriatic arthritis
Percentage of Participants With Peripheral Symptoms in Remission	11.1 Percentage of participants Interval 1.4 to 34.7	14.8 Percentage of participants Interval 7.0 to 26.2

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with ankylosing spondylitis with peripheral symptoms (DAS28 \> 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI \> 4)

The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Outcome measures

Measure	Ankylosing Spondylitis n=366 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis Mean change in BASDAI score, n=366	-4.6 Units on a scale Standard Deviation 2.3	—
Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis Mean change in DAS28 score, n=18	-1.9 Units on a scale Standard Deviation 1.3	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with active axial symptoms (a baseline value of BASDAI \> 4)

The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.

Outcome measures

Measure	Ankylosing Spondylitis n=358 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=51 Participants Participants with a diagnosis of psoriatic arthritis
Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) Mean change in ASDAS-CRP, n=299 and 45	-2.6 Units on a scale Standard Deviation 1.2	-1.9 Units on a scale Standard Deviation 1.7
Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) Mean change in ASDAS-ESR, n=358 and 51	-2.3 Units on a scale Standard Deviation 1.1	-1.9 Units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI \> 4)

BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).

Outcome measures

Measure	Ankylosing Spondylitis n=358 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis Correlation BASDAI and ASDAS-CRP, n=299	0.62 Correlation coefficient	—
Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis Correlation BASDAI and ASDAS-ESR, n=358	0.71 Correlation coefficient	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI \> 4)

A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.

Outcome measures

Measure	Ankylosing Spondylitis n=361 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis Response (Age), n=361	0.98 Odds Ratio Interval 0.96 to 1.0	—
Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis Response (Enthesitis at V0), n=361	2.47 Odds Ratio Interval 1.15 to 5.27	—
Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis Response (BASDAI at V0), n=361	1.18 Odds Ratio Interval 0.98 to 1.42	—
Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis Remission (Age), n=356	0.96 Odds Ratio Interval 0.95 to 0.98	—
Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis Remission (TB positive at V0), n=356	0.57 Odds Ratio Interval 0.3 to 1.06	—
Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis Remission (Male gender), n=356	1.77 Odds Ratio Interval 1.02 to 3.08	—
Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis Remission (BASDAI at V0), n=356	0.94 Odds Ratio Interval 0.8 to 1.12	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with ankylosing spondylitis with peripheral symptoms (DAS28 \> 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI \> 4)

HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.

Outcome measures

Measure	Ankylosing Spondylitis n=346 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis Mean change in HAQ-DI, n=30	-0.9 Units on a scale Standard Deviation 0.6	—
Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis Mean change in BASFI, n=346	-4.1 Units on a scale Standard Deviation 2.5	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants who received adalimumab treatment

Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Outcome measures

Measure	Ankylosing Spondylitis n=403 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=151 Participants Participants with a diagnosis of psoriatic arthritis
Mean Frequency of Extra-articular Manifestations (EAMs) Baseline (Visit 0), n=403, 151	0.5 Mean EAMs per participant Standard Deviation 0.6	1.1 Mean EAMs per participant Standard Deviation 0.6
Mean Frequency of Extra-articular Manifestations (EAMs) Visit 1 , n=400, 150	0.2 Mean EAMs per participant Standard Deviation 0.4	0.6 Mean EAMs per participant Standard Deviation 0.6
Mean Frequency of Extra-articular Manifestations (EAMs) Visit 2, n=357, 137	0.1 Mean EAMs per participant Standard Deviation 0.3	0.5 Mean EAMs per participant Standard Deviation 0.6
Mean Frequency of Extra-articular Manifestations (EAMs) Visit 3, n=339, 124	0.1 Mean EAMs per participant Standard Deviation 0.3	0.5 Mean EAMs per participant Standard Deviation 0.5
Mean Frequency of Extra-articular Manifestations (EAMs) Visit 4, n=324, 124	0.1 Mean EAMs per participant Standard Deviation 0.3	0.5 Mean EAMs per participant Standard Deviation 0.5
Mean Frequency of Extra-articular Manifestations (EAMs) Visit 4-LOCF, n=401, 151	0.1 Mean EAMs per participant Standard Deviation 0.3	0.5 Mean EAMs per participant Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants who received adalimumab treatment

The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.

Outcome measures

Measure	Ankylosing Spondylitis n=381 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=140 Participants Participants with a diagnosis of psoriatic arthritis
Duration of Treatment With Adalimumab No discontinuation of treatment, n=315, 117	11.8 Months Standard Deviation 1.2	11.6 Months Standard Deviation 1.1
Duration of Treatment With Adalimumab Discontinuation of treatment, n=66, 23	4.8 Months Standard Deviation 3.0	5.0 Months Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants who were receiving NSAID medication at baseline

Participants were surveyed at each study visit for their use of NSAID medication.

Outcome measures

Measure	Ankylosing Spondylitis n=265 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis n=39 Participants Participants with a diagnosis of psoriatic arthritis
Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study	96.6 Percentage of participants	94.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with ankylosing spondylitis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with ankylosing spondylitis who received adalimumab treatment.

Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.

Outcome measures

Measure	Ankylosing Spondylitis n=342 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis Mean change in absenteeism, n=170	-9.7 Percentage change Standard Deviation 24.4	—
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis Mean change in presenteeism, n=160	-37.3 Percentage change Standard Deviation 28.0	—
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis Mean change in work productivity impairment, n=160	-38.6 Percentage change Standard Deviation 28.8	—
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis Mean change in total activity impairment, n=342	-36.5 Percentage change Standard Deviation 26.7	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with ankylosing spondylitis who received adalimumab treatment

Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.

Outcome measures

Measure	Ankylosing Spondylitis n=403 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work Working at Baseline (Visit 0), n=403	56.6 Percentage of participants	—
Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work Working at last visit- valid data, n=351	56.1 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with psoriatic arthritis with peripheral symptoms (DAS28 \> 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI \> 4)

The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Outcome measures

Measure	Ankylosing Spondylitis n=61 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis Mean change in BASDAI score, n=52	-4.2 Units on a scale Standard Deviation 2.4	—
Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis Mean change in DAS28 score, n=61	-2.4 Units on a scale Standard Deviation 1.3	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI \> 4)

BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).

Outcome measures

Measure	Ankylosing Spondylitis n=51 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis Correlation BASDAI and ASDAS-CRP, n=45	0.75 Correlation coefficient	—
Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis Correlation BASDAI and ASDAS-ESR, n=51	0.84 Correlation coefficient	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI \> 4)

A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.

Outcome measures

Measure	Ankylosing Spondylitis n=52 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis Treatment response (Enthesitis at Visit 0)	0.23 Odds Ratio Interval 0.05 to 1.05	—
Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis Treatment response (BASDAI score at Visit 0)	1.35 Odds Ratio Interval 0.88 to 2.08	—
Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis Remission (Psoriasis at Visit 0)	0.21 Odds Ratio Interval 0.04 to 1.16	—
Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis Remission (BASDAI score at Visit 0)	0.87 Odds Ratio Interval 0.58 to 1.31	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with psoriatic arthritis with peripheral symptoms (DAS28 \> 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI \> 4)

HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning.

Outcome measures

Measure	Ankylosing Spondylitis n=88 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis Mean change in HAQ-DI, n=88	-0.7 Units on a scale Standard Deviation 0.6	—
Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis Mean change in BASFI, n=47	-3.8 Units on a scale Standard Deviation 2.8	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with psoriatic arthritis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with psoriatic arthritis who received adalimumab treatment.

The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.

Outcome measures

Measure	Ankylosing Spondylitis n=119 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis Mean change in absenteeism, n=57	-6.0 Percentage change Standard Deviation 29.0	—
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis Mean change in presenteeism, n=54	-32.8 Percentage change Standard Deviation 24.9	—
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis Mean change in work productivity impairment, n=54	-33.6 Percentage change Standard Deviation 25.4	—
Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis Mean change in total activity impairment, n=119	-34.7 Percentage change Standard Deviation 25.7	—

SECONDARY outcome

Timeframe: Baseline (Visit 0) to 12 months

Population: Participants with psoriatic arthritis who received adalimumab treatment

Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.

Outcome measures

Measure	Ankylosing Spondylitis n=151 Participants Participants with a diagnosis of ankylosing spondylitis	Psoriatic Arthritis Participants with a diagnosis of psoriatic arthritis
Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work Working at Baseline (Visit 0), n=151	55.6 Percentage of participants	—
Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work Working at last visit- valid data, n=140	54.3 Percentage of participants	—

Adverse Events

Overall Study Population

Serious events: 26 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Overall Study Population n=555 participants at risk Participants who received adalimumab treatment
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Skin and subcutaneous tissue disorders Skin ulcer	0.36% 2/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Surgical and medical procedures Carpal tunnel decompression	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Surgical and medical procedures Cataract operation	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Surgical and medical procedures Hip surgery	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Surgical and medical procedures Lymphadenectomy	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Surgical and medical procedures Phlebectomy	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Surgical and medical procedures Spinal laminectomy	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Vascular disorders Hypertension	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Ear and labyrinth disorders Hypoacusis	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Ear and labyrinth disorders Tinnitus	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Eye disorders Cataract	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Gastrointestinal disorders Abdominal pain	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Gastrointestinal disorders Abdominal pain upper	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Gastrointestinal disorders Hyperchlorhydria	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Gastrointestinal disorders Nausea	0.36% 2/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Gastrointestinal disorders Oral mucosal blistering	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Gastrointestinal disorders Vomiting	0.36% 2/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
General disorders Feeling abnormal	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
General disorders Injection site erythema	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
General disorders Injection site induration	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
General disorders Injection site rash	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
General disorders Pyrexia	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Immune system disorders Hypersensitivity	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Infections and infestations Erysipelas	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Infections and infestations Lymphadenitis bacterial	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Infections and infestations Pharyngitis	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Investigations Alanine aminotransferase increased	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Investigations Aspartate aminotransferase increased	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Investigations C-reactive protein increased	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Investigations Gamma-glutamyltransferase increased	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Investigations White blood cell count decreased	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Musculoskeletal and connective tissue disorders Arthritis	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Musculoskeletal and connective tissue disorders Morphoea	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Musculoskeletal and connective tissue disorders Pain in extremity	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Nervous system disorders Carpal tunnel syndrome	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Nervous system disorders Dysgeusia	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Nervous system disorders Guillain-Barre syndrome	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Nervous system disorders Headache	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Nervous system disorders Syncope	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Skin and subcutaneous tissue disorders Dermatitis	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.
Vascular disorders Thrombophlebitis superficial	0.18% 1/555 • Serious adverse events were collected from the time of adalimumab administration until the completion of the study, up to 52 weeks. In case of premature discontinuation, participants were followed for 70 days (5 half-lives) following the intake of the last dose of adalimumab.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Information

AbbVie

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER