Safety screening completion in patients initiating immune response mediator therapy for rheumatology, dermatology, and gastroenterology conditions: A multisite prospective analysis
1 Study Overview
1.1 Background
Despite the recommendation that patients initiating immune response mediator therapies for chronic autoimmune conditions be screened for tuberculosis (TB) and hepatitis B virus (HBV) prior to initiation, previous studies have found low screening rates.
This analysis assessed TB and HBV screening completion rates at the time of immune response mediator initiation and reasons for incomplete screening in health-system specialty pharmacies.
1.2 Methods
Multi-site (12 sites), prospective, observational cohort study.
Inclusion: Adult patients initiating a medication with risk for TB or HBV reactivation indicated for a rheumatology, dermatology, or gastroenterology condition between March 1 and May 31, 2023.
Exclusion: Biologic medication use within 1 year prior to index referral date, referral from a non-health system provider, lost to follow-up before screening or treatment initiation.
1.3 Outcomes
Rate of complete screening (defined as completing both TB and HBV screening) and rate and timing of TB screening and HBV screening.
2 Descriptive Statistics
2.1 Exclusions
| Characteristic | N = 7371 |
|---|---|
| Patient reported start date and first fill date | |
| No fill date or no patient reported start date | 554 (75.2%) |
| Patient reported start date after first fill date | 177 (24.0%) |
| Patient reported start date before first fill date | 6 (0.81%) |
| TB test order date and results date | |
| Tb results date after order date | 528 (71.6%) |
| No tb order date or no results date | 209 (28.4%) |
| HepB test order date and results date | |
| HepB results date after order date | 508 (68.9%) |
| No hepb order date or no results date | 229 (31.1%) |
| 1 n (%) | |
2.2 Patient Characteristics
| Characteristic | N | N = 7371 |
|---|---|---|
| Site | 737 | |
| Site 1 | 176 (23.9%) | |
| Site 2 | 129 (17.5%) | |
| Site 3 | 82 (11.1%) | |
| Site 4 | 78 (10.6%) | |
| Site 5 | 67 (9.09%) | |
| Site 6 | 61 (8.28%) | |
| Site 7 | 50 (6.78%) | |
| Site 8 | 38 (5.16%) | |
| Site 9 | 29 (3.93%) | |
| Site 10 | 14 (1.90%) | |
| Site 11 | 8 (1.09%) | |
| Site 12 | 5 (0.68%) | |
| Age at time of first referral | 737 | |
| Mean (SD) | 48 (16) | |
| Median (IQR) | 48 (36, 61) | |
| Range | 18, 86 | |
| Gender | 737 | |
| Female | 469 (63.6%) | |
| Male | 266 (36.1%) | |
| Other | 2 (0.27%) | |
| Race | 737 | |
| White | 492 (66.8%) | |
| Black or African American | 95 (12.9%) | |
| Not available | 55 (7.46%) | |
| Other | 32 (4.34%) | |
| Other Asian | 19 (2.58%) | |
| Unknown | 19 (2.58%) | |
| Decline to Answer | 14 (1.90%) | |
| American Indian or Alaska Native | 4 (0.54%) | |
| Native Hawaiian or Other Pacific Islander | 2 (0.27%) | |
| Vietnamese | 2 (0.27%) | |
| Asian Indian | 2 (0.27%) | |
| Chinese | 1 (0.14%) | |
| Primary Specialty Condition | 737 | |
| Rheumatoid Arthritis, M06 | 201 (27.3%) | |
| Psoriasis, L40.9 | 138 (18.7%) | |
| Psoriatic Arthritis, L40.5 | 124 (16.8%) | |
| Crohns Disease, K50 | 76 (10.3%) | |
| Hidradenitis Suppurativa, L73.2 | 54 (7.33%) | |
| Ankylosing Spondylitis, M45 | 47 (6.38%) | |
| Ulcerative Colitis, K51 | 38 (5.16%) | |
| Systemic Lupus Erythematosus, M32 | 29 (3.93%) | |
| Alopecia Areata, L63 | 12 (1.63%) | |
| Atopic Dermatitis, L20 | 10 (1.36%) | |
| Systemic Sclerosis/Scleroderma, M34 | 8 (1.09%) | |
| Clinical Area | 737 | |
| Rheumatology | 409 (55.5%) | |
| Dermatology | 214 (29.0%) | |
| Gastroenterology | 114 (15.5%) | |
| Specialty Medication Perscribed | 737 | |
| Adalimumab | 302 (41.0%) | |
| Risankizumab | 79 (10.7%) | |
| Etanercept | 71 (9.63%) | |
| Upadacitinib | 53 (7.19%) | |
| Ustekinumab | 52 (7.06%) | |
| Ixekizumab | 27 (3.66%) | |
| Belimumab | 26 (3.53%) | |
| Secukinumab | 25 (3.39%) | |
| Tofacitinib | 20 (2.71%) | |
| Certolizumab pegol | 18 (2.44%) | |
| Tocilizumab | 18 (2.44%) | |
| Guselkumab | 12 (1.63%) | |
| Golimumab | 11 (1.49%) | |
| Abatacept | 10 (1.36%) | |
| Baricitinib | 10 (1.36%) | |
| Sarilumab | 2 (0.27%) | |
| Tildrakizumab | 1 (0.14%) | |
| 1 n (%) | ||
3 Outcomes of Interest
3.1 HSSP Services Provided
3.1.1 Original detailed categories
| Service | Total (N=737) |
|---|---|
| Prior authorization support (coordination or completion) | 642 (87.1%) |
| Medication assistance support (counseling or obtainment) | 458 (62.1%) |
| Counsel/patient education | 542 (73.5%) |
| Dispense | 497 (67.4%) |
| Monitor therapy | 568 (77.1%) |
| No services- serviced by external specialty pharmacy only | 6 (0.8%) |
| Characteristic | N = 7371 |
|---|---|
| Number of HSSP services provided | |
| 0 | 6 (0.81%) |
| 1 | 26 (3.53%) |
| 2 | 51 (6.92%) |
| 3 | 241 (32.7%) |
| 4 | 209 (28.4%) |
| 5 | 204 (27.7%) |
| 1 n (%) | |
3.1.2 New generalized categories
| Service | Total (N=737) |
|---|---|
| Medication Access | 681 (92.4%) |
| Medication Education/Monitoring | 668 (90.6%) |
| Medication Dispensing | 497 (67.4%) |
| No Services | 6 (0.8%) |
| Characteristic | N = 7371 |
|---|---|
| Number of HSSP services provided | |
| 3 | 434 (58.9%) |
| 2 | 247 (33.5%) |
| 1 | 50 (6.78%) |
| 0 | 6 (0.81%) |
| 1 n (%) | |
3.2 TB Screening
| Characteristic | N | N = 7371 |
|---|---|---|
| TB screening completed - ever | 737 | |
| Yes | 708 (96.1%) | |
| No | 29 (3.93%) | |
| Was TB test ordered before first fill? | 417 | |
| Yes | 411 (98.6%) | |
| No | 6 (1.44%) | |
| Unknown | 320 | |
| Did TB results come in before first fill? | 498 | |
| Yes | 478 (96.0%) | |
| No | 20 (4.02%) | |
| Unknown | 239 | |
| Screened for TB within 2 years + 60 days | 737 | |
| Completed TB screening within 2 years + 60 days | 657 (89.1%) | |
| Completed TB screening not within 2 years + 60 days | 47 (6.38%) | |
| Never completed TB screening | 29 (3.93%) | |
| TB result date not available | 4 (0.54%) | |
| Screened for TB within 1 year + 60 days | 737 | |
| Completed TB screening within 1 year + 60 days | 620 (84.1%) | |
| Completed TB screening not within 1 year + 60 days | 84 (11.4%) | |
| Never completed TB screening | 29 (3.93%) | |
| TB result date not available | 4 (0.54%) | |
| Reason not screened smaller category | 29 | |
| Unknown | 10 (34.5%) | |
| Deemed unnecessary | 4 (13.8%) | |
| Relied on historical result | 4 (13.8%) | |
| Lab error | 2 (6.90%) | |
| Labs expected to be completed within reasonable timeframe of initiation | 2 (6.90%) | |
| Ordered labs not completed | 2 (6.90%) | |
| External labs not provided | 1 (3.45%) | |
| Infectious Diseases consulted | 1 (3.45%) | |
| Insurance denial | 1 (3.45%) | |
| Patient not ready to start therapy | 1 (3.45%) | |
| Therapy changed | 1 (3.45%) | |
| Unknown | 708 | |
| Reason not screened larger category | 29 | |
| Provider driven | 11 (37.9%) | |
| Unknown | 10 (34.5%) | |
| Patient driven | 4 (13.8%) | |
| Lab error | 2 (6.90%) | |
| Noninitiation | 2 (6.90%) | |
| Unknown | 708 | |
| Specialty meds for patients that did not complete TB screening | 29 | |
| Adalimumab | 7 (24.1%) | |
| Belimumab | 6 (20.7%) | |
| Risankizumab | 5 (17.2%) | |
| Ustekinumab | 4 (13.8%) | |
| Etanercept | 2 (6.90%) | |
| Baricitinib | 1 (3.45%) | |
| Certolizumab pegol | 1 (3.45%) | |
| Secukinumab | 1 (3.45%) | |
| Tocilizumab | 1 (3.45%) | |
| Tofacitinib | 1 (3.45%) | |
| Unknown | 708 | |
| 1 n (%) | ||
| Characteristic | N | N = 737 |
|---|---|---|
| Days between TB results and first fill | 498 | |
| Mean (SD) | 139.5 (327.0) | |
| Median (IQR) | 20.0 (6.0 - 98.0) | |
| Range | -248.0 - 2355.0 | |
| Unknown | 239 | |
| Days between TB test ordered and first fill | 417 | |
| Mean (SD) | 89.5 (211.7) | |
| Median (IQR) | 24.0 (10.0 - 78.0) | |
| Range | -247.0 - 1971.0 | |
| Unknown | 320 |
| Characteristic | N | Dermatology, N = 2141 | Gastroenterology, N = 1141 | Rheumatology, N = 4091 |
|---|---|---|---|---|
| Completed TB screening - ever | 737 | |||
| Yes | 205 (95.8%) | 111 (97.4%) | 392 (95.8%) | |
| No | 9 (4.21%) | 3 (2.63%) | 17 (4.16%) | |
| Reason not screened smaller category | 29 | |||
| Unknown | 3 (33.3%) | 2 (66.7%) | 5 (29.4%) | |
| Deemed unnecessary | 0 (0%) | 0 (0%) | 4 (23.5%) | |
| Relied on historical result | 1 (11.1%) | 0 (0%) | 3 (17.6%) | |
| Lab error | 2 (22.2%) | 0 (0%) | 0 (0%) | |
| Labs expected to be completed within reasonable timeframe of initiation | 0 (0%) | 1 (33.3%) | 1 (5.88%) | |
| Ordered labs not completed | 0 (0%) | 0 (0%) | 2 (11.8%) | |
| External labs not provided | 1 (11.1%) | 0 (0%) | 0 (0%) | |
| Infectious Diseases consulted | 0 (0%) | 0 (0%) | 1 (5.88%) | |
| Insurance denial | 1 (11.1%) | 0 (0%) | 0 (0%) | |
| Patient not ready to start therapy | 0 (0%) | 0 (0%) | 1 (5.88%) | |
| Therapy changed | 1 (11.1%) | 0 (0%) | 0 (0%) | |
| Unknown | 205 | 111 | 392 | |
| Reason not screened larger catgeory | 29 | |||
| Provider driven | 1 (11.1%) | 1 (33.3%) | 9 (52.9%) | |
| Unknown | 3 (33.3%) | 2 (66.7%) | 5 (29.4%) | |
| Patient driven | 1 (11.1%) | 0 (0%) | 3 (17.6%) | |
| Lab error | 2 (22.2%) | 0 (0%) | 0 (0%) | |
| Noninitiation | 2 (22.2%) | 0 (0%) | 0 (0%) | |
| Unknown | 205 | 111 | 392 | |
| Drugs for which screening was not completed | 29 | |||
| Adalimumab | 3 (33.3%) | 1 (33.3%) | 3 (17.6%) | |
| Belimumab | 0 (0%) | 0 (0%) | 6 (35.3%) | |
| Risankizumab | 3 (33.3%) | 0 (0%) | 2 (11.8%) | |
| Ustekinumab | 1 (11.1%) | 2 (66.7%) | 1 (5.88%) | |
| Etanercept | 0 (0%) | 0 (0%) | 2 (11.8%) | |
| Baricitinib | 1 (11.1%) | 0 (0%) | 0 (0%) | |
| Certolizumab pegol | 0 (0%) | 0 (0%) | 1 (5.88%) | |
| Secukinumab | 1 (11.1%) | 0 (0%) | 0 (0%) | |
| Tocilizumab | 0 (0%) | 0 (0%) | 1 (5.88%) | |
| Tofacitinib | 0 (0%) | 0 (0%) | 1 (5.88%) | |
| Unknown | 205 | 111 | 392 | |
| 1 n (%) | ||||
3.3 HBV Screening
| Characteristic | N | N = 7371 |
|---|---|---|
| HBV screening completed - ever | 737 | |
| Yes | 695 (94.3%) | |
| No | 23 (3.12%) | |
| Provider deemed unnecessary | 19 (2.58%) | |
| Was HBV test ordered before first fill? | 401 | |
| Yes | 397 (99.0%) | |
| No | 4 (1.00%) | |
| Unknown | 336 | |
| Did HBV results come in before first fill? | 481 | |
| Yes | 470 (97.7%) | |
| No | 11 (2.29%) | |
| Unknown | 256 | |
| Screened for HBV within 2 years + 60 days | 737 | |
| Completed HBV screening within 2 years + 60 days | 616 (83.6%) | |
| Completed HBV screening not within 2 years + 60 days | 68 (9.23%) | |
| Never completed HBV screening | 23 (3.12%) | |
| Provider deemed HBV screening unnecessary | 19 (2.58%) | |
| HBV result date not available | 11 (1.49%) | |
| Screened for HBV within 1 year + 60 days | 737 | |
| Completed HBV screening within 1 year + 60 days | 572 (77.6%) | |
| Completed HBV screening not within 1 year + 60 days | 112 (15.2%) | |
| Never completed HBV screening | 23 (3.12%) | |
| Provider deemed HBV screening unnecessary | 19 (2.58%) | |
| HBV result date not available | 11 (1.49%) | |
| Method of Screening | 694 | |
| Lab screening | 686 (98.8%) | |
| Patient report (documented by pharmacist or provider) | 8 (1.15%) | |
| Unknown | 43 | |
| Reason not screened smaller category | 42 | |
| Unknown | 11 (26.2%) | |
| Relied on historical result | 8 (19.0%) | |
| HBV screening not indicated | 5 (11.9%) | |
| Deemed Unnecessary | 4 (9.52%) | |
| Evidence of Vaccination | 4 (9.52%) | |
| Ordered labs not completed | 3 (7.14%) | |
| Chronic HBV infection | 1 (2.38%) | |
| External labs not provided | 1 (2.38%) | |
| Insurance denial | 1 (2.38%) | |
| Labs expected to be completed within reasonable timeframe of initiation | 1 (2.38%) | |
| Patient not ready to start therapy | 1 (2.38%) | |
| Therapy changed | 1 (2.38%) | |
| Urgent initiation needed | 1 (2.38%) | |
| Unknown | 695 | |
| Reason not screened larger category | 42 | |
| Provider driven | 20 (47.6%) | |
| Unknown | 11 (26.2%) | |
| Patient driven | 5 (11.9%) | |
| Record of immunity | 4 (9.52%) | |
| Noninitiation | 2 (4.76%) | |
| Unknown | 695 | |
| Specialty meds for patients that did not complete HBV screening | 23 | |
| Adalimumab | 9 (39.1%) | |
| Risankizumab | 4 (17.4%) | |
| Ustekinumab | 3 (13.0%) | |
| Baricitinib | 2 (8.70%) | |
| Belimumab | 2 (8.70%) | |
| Etanercept | 2 (8.70%) | |
| Certolizumab pegol | 1 (4.35%) | |
| Unknown | 714 | |
| Specialty meds for patients for which provider deemed HBV screening unnecessary | 19 | |
| Adalimumab | 6 (31.6%) | |
| Ustekinumab | 5 (26.3%) | |
| Belimumab | 4 (21.1%) | |
| Abatacept | 1 (5.26%) | |
| Baricitinib | 1 (5.26%) | |
| Secukinumab | 1 (5.26%) | |
| Tofacitinib | 1 (5.26%) | |
| Unknown | 718 | |
| 1 n (%) | ||
| Characteristic | N | N = 737 |
|---|---|---|
| Days between HBV results and first fill | 481 | |
| Mean (SD) | 193.3 (439.2) | |
| Median (IQR) | 27.0 (8.0 - 158.0) | |
| Range | -296.0 - 3897.0 | |
| Unknown | 256 | |
| Days between HBV test ordered and first fill | 401 | |
| Mean (SD) | 139.7 (347.2) | |
| Median (IQR) | 27.0 (10.0 - 98.0) | |
| Range | -69.0 - 3030.0 | |
| Unknown | 336 |
| Characteristic | N | Dermatology, N = 2141 | Gastroenterology, N = 1141 | Rheumatology, N = 4091 |
|---|---|---|---|---|
| Completed TB screening - ever | 737 | |||
| Yes | 202 (94.4%) | 104 (91.2%) | 389 (95.1%) | |
| No | 10 (4.67%) | 4 (3.51%) | 9 (2.20%) | |
| Provider deemed unnecessary | 2 (0.93%) | 6 (5.26%) | 11 (2.69%) | |
| Reason not screened smaller category | 42 | |||
| Unknown | 3 (25.0%) | 3 (30.0%) | 5 (25.0%) | |
| Relied on historical result | 3 (25.0%) | 0 (0%) | 5 (25.0%) | |
| HBV screening not indicated | 0 (0%) | 3 (30.0%) | 2 (10.0%) | |
| Deemed Unnecessary | 1 (8.33%) | 1 (10.0%) | 2 (10.0%) | |
| Evidence of Vaccination | 0 (0%) | 1 (10.0%) | 3 (15.0%) | |
| Ordered labs not completed | 2 (16.7%) | 0 (0%) | 1 (5.00%) | |
| Chronic HBV infection | 0 (0%) | 0 (0%) | 1 (5.00%) | |
| External labs not provided | 1 (8.33%) | 0 (0%) | 0 (0%) | |
| Insurance denial | 1 (8.33%) | 0 (0%) | 0 (0%) | |
| Labs expected to be completed within reasonable timeframe of initiation | 0 (0%) | 1 (10.0%) | 0 (0%) | |
| Patient not ready to start therapy | 0 (0%) | 0 (0%) | 1 (5.00%) | |
| Therapy changed | 1 (8.33%) | 0 (0%) | 0 (0%) | |
| Urgent initiation needed | 0 (0%) | 1 (10.0%) | 0 (0%) | |
| Unknown | 202 | 104 | 389 | |
| Reason not screened larger catgeory | 42 | |||
| Provider driven | 4 (33.3%) | 6 (60.0%) | 10 (50.0%) | |
| Unknown | 3 (25.0%) | 3 (30.0%) | 5 (25.0%) | |
| Patient driven | 3 (25.0%) | 0 (0%) | 2 (10.0%) | |
| Record of immunity | 0 (0%) | 1 (10.0%) | 3 (15.0%) | |
| Noninitiation | 2 (16.7%) | 0 (0%) | 0 (0%) | |
| Unknown | 202 | 104 | 389 | |
| Drugs for which screening was not completed | 42 | |||
| Adalimumab | 4 (33.3%) | 3 (30.0%) | 8 (40.0%) | |
| Ustekinumab | 1 (8.33%) | 7 (70.0%) | 0 (0%) | |
| Belimumab | 0 (0%) | 0 (0%) | 6 (30.0%) | |
| Risankizumab | 3 (25.0%) | 0 (0%) | 1 (5.00%) | |
| Baricitinib | 3 (25.0%) | 0 (0%) | 0 (0%) | |
| Etanercept | 0 (0%) | 0 (0%) | 2 (10.0%) | |
| Abatacept | 0 (0%) | 0 (0%) | 1 (5.00%) | |
| Certolizumab pegol | 0 (0%) | 0 (0%) | 1 (5.00%) | |
| Secukinumab | 1 (8.33%) | 0 (0%) | 0 (0%) | |
| Tofacitinib | 0 (0%) | 0 (0%) | 1 (5.00%) | |
| Unknown | 202 | 104 | 389 | |
| 1 n (%) | ||||
3.4 Complete Safety Screening
3.4.1 Screenings before first fill
| Characteristic | N | N = 7371 |
|---|---|---|
| Were both safety screenings completed before first fill? | 737 | |
| Yes | 449 (60.9%) | |
| Missing first fill date | 200 (27.1%) | |
| Missing tb or hbv result dates | 43 (5.83%) | |
| Missing first fill date and tb or hbv result dates | 20 (2.71%) | |
| TB screening not completed before first fill | 14 (1.90%) | |
| HBV screening not completed before first fill | 8 (1.09%) | |
| Neither screenings completed before first fill | 3 (0.41%) | |
| 1 n (%) | ||
| Characteristic | N | N = 7371 |
|---|---|---|
| Were both safety screenings ordered before first fill? | 737 | |
| Yes | 389 (52.8%) | |
| Missing tb or hbv order dates | 122 (16.6%) | |
| Missing first fill date and tb or hbv order dates | 112 (15.2%) | |
| Missing first fill date | 108 (14.7%) | |
| HBV screening not ordered before first fill | 3 (0.41%) | |
| TB screening not ordered before first fill | 2 (0.27%) | |
| Neither screenings ordered before first fill | 1 (0.14%) | |
| 1 n (%) | ||
3.4.2 By HSSP services (No time restriction)
| Characteristic | N | Medication dispensing, N = 4971 | No medication dispensing services, N = 2401 |
|---|---|---|---|
| Completed TB screening | 737 | ||
| Yes | 479 (96.4%) | 229 (95.4%) | |
| No | 18 (3.62%) | 11 (4.58%) | |
| Completed HBV screening | 737 | ||
| Yes | 471 (94.8%) | 224 (93.3%) | |
| No | 15 (3.02%) | 8 (3.33%) | |
| Provider deemed unnecessary | 11 (2.21%) | 8 (3.33%) | |
| 1 n (%) | |||
| Characteristic | N | Medication Access, N = 6811 | No medication access services, N = 561 |
|---|---|---|---|
| Completed TB screening | 737 | ||
| Yes | 655 (96.2%) | 53 (94.6%) | |
| No | 26 (3.82%) | 3 (5.36%) | |
| Completed HBV screening | 737 | ||
| Yes | 642 (94.3%) | 53 (94.6%) | |
| No | 22 (3.23%) | 1 (1.79%) | |
| Provider deemed unnecessary | 17 (2.50%) | 2 (3.57%) | |
| 1 n (%) | |||
| Characteristic | N | Medication Education/monitoring, N = 6681 | No medication education/monitoring services, N = 691 |
|---|---|---|---|
| Completed TB screening | 737 | ||
| Yes | 644 (96.4%) | 64 (92.8%) | |
| No | 24 (3.59%) | 5 (7.25%) | |
| Completed HBV screening | 737 | ||
| Yes | 636 (95.2%) | 59 (85.5%) | |
| No | 18 (2.69%) | 5 (7.25%) | |
| Provider deemed unnecessary | 14 (2.10%) | 5 (7.25%) | |
| 1 n (%) | |||
3.4.3 Completed Screening restricted to 2 years + 60 days
| Characteristic | N | N = 7371 |
|---|---|---|
| Did patient complete TB screening within 2 years + 60 days of referral? | 737 | |
| Completed TB screening within 2 years + 60 days | 657 (89.1%) | |
| Completed TB screening not within 2 years + 60 days | 47 (6.38%) | |
| Never completed TB screening | 29 (3.93%) | |
| TB result date not available | 4 (0.54%) | |
| Did patient complete HBV screening within 2 years + 60 days of referral? | 737 | |
| Completed HBV screening within 2 years + 60 days | 616 (83.6%) | |
| Completed HBV screening not within 2 years + 60 days | 68 (9.23%) | |
| Never completed HBV screening | 23 (3.12%) | |
| Provider deemed HBV screening unnecessary | 19 (2.58%) | |
| HBV result date not available | 11 (1.49%) | |
| Did patient complete both screenings within 2 years + 60 days of referral? | 737 | |
| Completed both screenings before 2 years + 60 days | 601 (81.5%) | |
| Did not complete both screenings before 2 years + 60 days | 136 (18.5%) | |
| 1 n (%) | ||
3.5 Regression analysis of Complete Safety screening associated with number of HSSP services provided
| OR | P-value | |
|---|---|---|
| 2 services | 2.07 | 0.027 |
| 3 services | 2.38 | 0.006 |
| OR | P-value | |
|---|---|---|
| 1 additional service | 1.23 | 0.012 |
3.6 Frequency of completion restricted to 2 years + 60 days by level of service
| Characteristic | N | 0, N = 61 | 1, N = 501 | 2, N = 2471 | 3, N = 4341 |
|---|---|---|---|---|---|
| Did patient complete TB screening within 2 years + 60 days of referral? | 737 | ||||
| Completed TB screening within 2 years + 60 days | 2 (33.3%) | 41 (82.0%) | 226 (91.5%) | 388 (89.4%) | |
| Completed TB screening not within 2 years + 60 days | 1 (16.7%) | 5 (10.0%) | 15 (6.07%) | 26 (5.99%) | |
| Never completed TB screening | 3 (50.0%) | 2 (4.00%) | 6 (2.43%) | 18 (4.15%) | |
| TB result date not available | 0 (0%) | 2 (4.00%) | 0 (0%) | 2 (0.46%) | |
| Did patient complete HBV screening within 2 years + 60 days of referral? | 737 | ||||
| Completed HBV screening within 2 years + 60 days | 2 (33.3%) | 37 (74.0%) | 206 (83.4%) | 371 (85.5%) | |
| Completed HBV screening not within 2 years + 60 days | 1 (16.7%) | 6 (12.0%) | 30 (12.1%) | 31 (7.14%) | |
| Never completed HBV screening | 1 (16.7%) | 3 (6.00%) | 5 (2.02%) | 14 (3.23%) | |
| Provider deemed HBV screening unnecessary | 2 (33.3%) | 3 (6.00%) | 3 (1.21%) | 11 (2.53%) | |
| HBV result date not available | 0 (0%) | 1 (2.00%) | 3 (1.21%) | 7 (1.61%) | |
| Did patient complete both screenings within 2 years + 60 days of referral? | 737 | ||||
| Completed both screenings before 2 years + 60 days | 2 (33.3%) | 36 (72.0%) | 201 (81.4%) | 362 (83.4%) | |
| Did not complete both screenings before 2 years + 60 days | 4 (66.7%) | 14 (28.0%) | 46 (18.6%) | 72 (16.6%) | |
| 1 n (%) | |||||
3.7 Patient screening overview
| Characteristic | N | N = 7371 |
|---|---|---|
| Were both safety screenings ever completed? | 737 | |
| Yes | 701 (95.1%) | |
| No | 36 (4.88%) | |
| Were both safety screenings completed within 2 years + 60 days of referral | 737 | |
| Yes | 601 (81.5%) | |
| No or result dates not known | 136 (18.5%) | |
| Were both safety screenings completed within 1 year + 60 days of referral | 737 | |
| Yes | 555 (75.3%) | |
| No or result dates not known | 182 (24.7%) | |
| 1 n (%) | ||
| Characteristic | N | Overall, N = 7371 | Dermatology, N = 2141 | Gastroenterology, N = 1141 | Rheumatology, N = 4091 |
|---|---|---|---|---|---|
| Ever screened for TB | 737 | ||||
| Yes | 708 (96.1%) | 205 (95.8%) | 111 (97.4%) | 392 (95.8%) | |
| No | 29 (3.93%) | 9 (4.21%) | 3 (2.63%) | 17 (4.16%) | |
| Ever screened for HBV | 737 | ||||
| Yes | 714 (96.9%) | 204 (95.3%) | 110 (96.5%) | 400 (97.8%) | |
| No | 23 (3.12%) | 10 (4.67%) | 4 (3.51%) | 9 (2.20%) | |
| Ever screened complete | 737 | ||||
| Yes | 701 (95.1%) | 202 (94.4%) | 110 (96.5%) | 389 (95.1%) | |
| No | 36 (4.88%) | 12 (5.61%) | 4 (3.51%) | 20 (4.89%) | |
| TB screening within 2 years + 60 days | 737 | ||||
| Yes | 657 (89.1%) | 197 (92.1%) | 96 (84.2%) | 364 (89.0%) | |
| No | 76 (10.3%) | 15 (7.01%) | 18 (15.8%) | 43 (10.5%) | |
| Completed but uncertain if within or outside window | 4 (0.54%) | 2 (0.93%) | 0 (0%) | 2 (0.49%) | |
| HBV screening within 2 years + 60 days | 737 | ||||
| Yes | 635 (86.2%) | 189 (88.3%) | 94 (82.5%) | 352 (86.1%) | |
| No | 91 (12.3%) | 23 (10.7%) | 17 (14.9%) | 51 (12.5%) | |
| Completed but uncertain if within or outside window | 11 (1.49%) | 2 (0.93%) | 3 (2.63%) | 6 (1.47%) | |
| Complete screening within 2 years + 60 days | 737 | ||||
| Yes | 601 (81.5%) | 183 (85.5%) | 86 (75.4%) | 332 (81.2%) | |
| No | 122 (16.6%) | 28 (13.1%) | 25 (21.9%) | 69 (16.9%) | |
| Completed but uncertain if within or outside window | 14 (1.90%) | 3 (1.40%) | 3 (2.63%) | 8 (1.96%) | |
| TB screening within 1 year + 60 days | 737 | ||||
| Yes | 620 (84.1%) | 195 (91.1%) | 90 (78.9%) | 335 (81.9%) | |
| No | 113 (15.3%) | 17 (7.94%) | 24 (21.1%) | 72 (17.6%) | |
| Completed but uncertain if within or outside window | 4 (0.54%) | 2 (0.93%) | 0 (0%) | 2 (0.49%) | |
| HBV screening within 1 year + 60 days | 737 | ||||
| Yes | 591 (80.2%) | 187 (87.4%) | 85 (74.6%) | 319 (78.0%) | |
| No | 135 (18.3%) | 25 (11.7%) | 26 (22.8%) | 84 (20.5%) | |
| Completed but uncertain if within or outside window | 11 (1.49%) | 2 (0.93%) | 3 (2.63%) | 6 (1.47%) | |
| Complete screening within 1 year + 60 days | 737 | ||||
| Yes | 555 (75.3%) | 180 (84.1%) | 76 (66.7%) | 299 (73.1%) | |
| No | 168 (22.8%) | 31 (14.5%) | 35 (30.7%) | 102 (24.9%) | |
| Completed but uncertain if within or outside window | 14 (1.90%) | 3 (1.40%) | 3 (2.63%) | 8 (1.96%) | |
| 1 n (%) | |||||
3.8 Bar graph of screening counts
3.9 Bar graph of screening rates within 1 year + 60 days by clinical area
3.10 Boxplot of time between screening results and first fill
3.11 Histograms of screening results relative to referral
3.12 Details on drugs that never completed safety screenings
3.12.1 Drugs of patients who did not complete safety screening
| Characteristic | No, N = 291 | Yes, N = 7081 |
|---|---|---|
| Specialty Medication | ||
| Adalimumab | 7 (2.32%) | 295 (97.7%) |
| Risankizumab | 5 (6.33%) | 74 (93.7%) |
| Etanercept | 2 (2.82%) | 69 (97.2%) |
| Upadacitinib | 0 (0%) | 53 (100.0%) |
| Ustekinumab | 4 (7.69%) | 48 (92.3%) |
| Ixekizumab | 0 (0%) | 27 (100.0%) |
| Belimumab | 6 (23.1%) | 20 (76.9%) |
| Secukinumab | 1 (4.00%) | 24 (96.0%) |
| Tofacitinib | 1 (5.00%) | 19 (95.0%) |
| Certolizumab pegol | 1 (5.56%) | 17 (94.4%) |
| Tocilizumab | 1 (5.56%) | 17 (94.4%) |
| Guselkumab | 0 (0%) | 12 (100.0%) |
| Golimumab | 0 (0%) | 11 (100.0%) |
| Abatacept | 0 (0%) | 10 (100.0%) |
| Baricitinib | 1 (10.0%) | 9 (90.0%) |
| Sarilumab | 0 (0%) | 2 (100.0%) |
| Tildrakizumab | 0 (0%) | 1 (100.0%) |
| 1 n (%) | ||
| Characteristic | Yes, N = 6951 | No, N = 231 | Provider deemed unnecessary, N = 191 |
|---|---|---|---|
| Specialty Medication | |||
| Adalimumab | 287 (95.0%) | 9 (2.98%) | 6 (1.99%) |
| Risankizumab | 75 (94.9%) | 4 (5.06%) | 0 (0%) |
| Etanercept | 69 (97.2%) | 2 (2.82%) | 0 (0%) |
| Upadacitinib | 53 (100.0%) | 0 (0%) | 0 (0%) |
| Ustekinumab | 44 (84.6%) | 3 (5.77%) | 5 (9.62%) |
| Ixekizumab | 27 (100.0%) | 0 (0%) | 0 (0%) |
| Belimumab | 20 (76.9%) | 2 (7.69%) | 4 (15.4%) |
| Secukinumab | 24 (96.0%) | 0 (0%) | 1 (4.00%) |
| Tofacitinib | 19 (95.0%) | 0 (0%) | 1 (5.00%) |
| Certolizumab pegol | 17 (94.4%) | 1 (5.56%) | 0 (0%) |
| Tocilizumab | 18 (100.0%) | 0 (0%) | 0 (0%) |
| Guselkumab | 12 (100.0%) | 0 (0%) | 0 (0%) |
| Golimumab | 11 (100.0%) | 0 (0%) | 0 (0%) |
| Abatacept | 9 (90.0%) | 0 (0%) | 1 (10.0%) |
| Baricitinib | 7 (70.0%) | 2 (20.0%) | 1 (10.0%) |
| Sarilumab | 2 (100.0%) | 0 (0%) | 0 (0%) |
| Tildrakizumab | 1 (100.0%) | 0 (0%) | 0 (0%) |
| 1 n (%) | |||
3.12.2 Drugs of patients who did not complete safety screening within 2 years + 60 days of referral
| Characteristic | Completed TB screening not within 2 years + 60 days, N = 471 | Completed TB screening within 2 years + 60 days, N = 6571 | Never completed TB screening, N = 291 | TB result date not available, N = 41 |
|---|---|---|---|---|
| Specialty Medication | ||||
| Adalimumab | 10 (3.31%) | 283 (93.7%) | 7 (2.32%) | 2 (0.66%) |
| Risankizumab | 2 (2.53%) | 72 (91.1%) | 5 (6.33%) | 0 (0%) |
| Etanercept | 7 (9.86%) | 62 (87.3%) | 2 (2.82%) | 0 (0%) |
| Upadacitinib | 9 (17.0%) | 44 (83.0%) | 0 (0%) | 0 (0%) |
| Ustekinumab | 4 (7.69%) | 44 (84.6%) | 4 (7.69%) | 0 (0%) |
| Ixekizumab | 3 (11.1%) | 24 (88.9%) | 0 (0%) | 0 (0%) |
| Belimumab | 2 (7.69%) | 18 (69.2%) | 6 (23.1%) | 0 (0%) |
| Secukinumab | 0 (0%) | 24 (96.0%) | 1 (4.00%) | 0 (0%) |
| Tofacitinib | 3 (15.0%) | 16 (80.0%) | 1 (5.00%) | 0 (0%) |
| Certolizumab pegol | 3 (16.7%) | 14 (77.8%) | 1 (5.56%) | 0 (0%) |
| Tocilizumab | 1 (5.56%) | 15 (83.3%) | 1 (5.56%) | 1 (5.56%) |
| Guselkumab | 0 (0%) | 11 (91.7%) | 0 (0%) | 1 (8.33%) |
| Golimumab | 3 (27.3%) | 8 (72.7%) | 0 (0%) | 0 (0%) |
| Abatacept | 0 (0%) | 10 (100.0%) | 0 (0%) | 0 (0%) |
| Baricitinib | 0 (0%) | 9 (90.0%) | 1 (10.0%) | 0 (0%) |
| Sarilumab | 0 (0%) | 2 (100.0%) | 0 (0%) | 0 (0%) |
| Tildrakizumab | 0 (0%) | 1 (100.0%) | 0 (0%) | 0 (0%) |
| 1 n (%) | ||||
| Characteristic | Completed HBV screening not within 2 years + 60 days, N = 681 | Completed HBV screening within 2 years + 60 days, N = 6161 | HBV result date not available, N = 111 | Never completed HBV screening, N = 231 | Provider deemed HBV screening unnecessary, N = 191 |
|---|---|---|---|---|---|
| Specialty Medication | |||||
| Adalimumab | 15 (4.97%) | 266 (88.1%) | 6 (1.99%) | 9 (2.98%) | 6 (1.99%) |
| Risankizumab | 3 (3.80%) | 72 (91.1%) | 0 (0%) | 4 (5.06%) | 0 (0%) |
| Etanercept | 8 (11.3%) | 60 (84.5%) | 1 (1.41%) | 2 (2.82%) | 0 (0%) |
| Upadacitinib | 10 (18.9%) | 41 (77.4%) | 2 (3.77%) | 0 (0%) | 0 (0%) |
| Ustekinumab | 6 (11.5%) | 38 (73.1%) | 0 (0%) | 3 (5.77%) | 5 (9.62%) |
| Ixekizumab | 3 (11.1%) | 24 (88.9%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Belimumab | 4 (15.4%) | 15 (57.7%) | 1 (3.85%) | 2 (7.69%) | 4 (15.4%) |
| Secukinumab | 3 (12.0%) | 21 (84.0%) | 0 (0%) | 0 (0%) | 1 (4.00%) |
| Tofacitinib | 4 (20.0%) | 15 (75.0%) | 0 (0%) | 0 (0%) | 1 (5.00%) |
| Certolizumab pegol | 3 (16.7%) | 14 (77.8%) | 0 (0%) | 1 (5.56%) | 0 (0%) |
| Tocilizumab | 3 (16.7%) | 15 (83.3%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Guselkumab | 1 (8.33%) | 10 (83.3%) | 1 (8.33%) | 0 (0%) | 0 (0%) |
| Golimumab | 5 (45.5%) | 6 (54.5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Abatacept | 0 (0%) | 9 (90.0%) | 0 (0%) | 0 (0%) | 1 (10.0%) |
| Baricitinib | 0 (0%) | 7 (70.0%) | 0 (0%) | 2 (20.0%) | 1 (10.0%) |
| Sarilumab | 0 (0%) | 2 (100.0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Tildrakizumab | 0 (0%) | 1 (100.0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| 1 n (%) | |||||
3.12.3 Drugs of patients who did not complete safety screening (smaller category)
| Specialty Medication | Frequency |
|---|---|
| Deemed unnecessary | |
| Belimumab | 4 |
| External labs not provided | |
| Ustekinumab | 1 |
| Infectious Diseases consulted | |
| Adalimumab | 1 |
| Insurance denial | |
| Risankizumab | 1 |
| Lab error | |
| Baricitinib | 1 |
| Risankizumab | 1 |
| Labs expected to be completed within reasonable timeframe of initiation | |
| Ustekinumab | 2 |
| Ordered labs not completed | |
| Certolizumab pegol | 1 |
| Etanercept | 1 |
| Patient not ready to start therapy | |
| Belimumab | 1 |
| Relied on historical result | |
| Adalimumab | 1 |
| Secukinumab | 1 |
| Tocilizumab | 1 |
| Tofacitinib | 1 |
| Therapy changed | |
| Risankizumab | 1 |
| Unknown | |
| Adalimumab | 5 |
| Belimumab | 1 |
| Etanercept | 1 |
| Risankizumab | 2 |
| Ustekinumab | 1 |
| Specialty Medication | Frequency |
|---|---|
| Deemed Unnecessary | |
| Adalimumab | 2 |
| External labs not provided | |
| Ustekinumab | 1 |
| Insurance denial | |
| Risankizumab | 1 |
| Labs expected to be completed within reasonable timeframe of initiation | |
| Ustekinumab | 1 |
| Ordered labs not completed | |
| Baricitinib | 2 |
| Certolizumab pegol | 1 |
| Patient not ready to start therapy | |
| Belimumab | 1 |
| Relied on historical result | |
| Adalimumab | 1 |
| Risankizumab | 1 |
| Therapy changed | |
| Risankizumab | 1 |
| Unknown | |
| Adalimumab | 6 |
| Etanercept | 2 |
| Belimumab | 1 |
| Risankizumab | 1 |
| Ustekinumab | 1 |
3.12.4 Drugs of patients who did not complete safety screening within 2 years + 60 days of referral (smaller category)
| Specialty Medication | Frequency |
|---|---|
| Deemed unnecessary | |
| Belimumab | 4 |
| External labs not provided | |
| Ustekinumab | 1 |
| Infectious Diseases consulted | |
| Adalimumab | 1 |
| Insurance denial | |
| Risankizumab | 1 |
| Lab error | |
| Baricitinib | 1 |
| Risankizumab | 1 |
| Labs expected to be completed within reasonable timeframe of initiation | |
| Ustekinumab | 2 |
| Ordered labs not completed | |
| Certolizumab pegol | 1 |
| Etanercept | 1 |
| Patient not ready to start therapy | |
| Belimumab | 1 |
| Relied on historical result | |
| Adalimumab | 1 |
| Secukinumab | 1 |
| Tocilizumab | 1 |
| Tofacitinib | 1 |
| Screening completed historically | |
| Adalimumab | 12 |
| Upadacitinib | 9 |
| Etanercept | 7 |
| Ustekinumab | 4 |
| Certolizumab pegol | 3 |
| Golimumab | 3 |
| Ixekizumab | 3 |
| Tofacitinib | 3 |
| Belimumab | 2 |
| Risankizumab | 2 |
| Tocilizumab | 2 |
| Guselkumab | 1 |
| Therapy changed | |
| Risankizumab | 1 |
| Unknown | |
| Adalimumab | 5 |
| Risankizumab | 2 |
| Belimumab | 1 |
| Etanercept | 1 |
| Ustekinumab | 1 |
| Specialty Medication | Frequency |
|---|---|
| Deemed unnecessary | |
| Adalimumab | 2 |
| External labs not provided | |
| Ustekinumab | 1 |
| Insurance denial | |
| Risankizumab | 1 |
| Labs expected to be completed within reasonable timeframe of initiation | |
| Ustekinumab | 1 |
| Ordered labs not completed | |
| Baricitinib | 2 |
| Certolizumab pegol | 1 |
| Patient not ready to start therapy | |
| Belimumab | 1 |
| Relied on historical result | |
| Adalimumab | 1 |
| Risankizumab | 1 |
| Screening completed historically | |
| Adalimumab | 21 |
| Upadacitinib | 12 |
| Etanercept | 9 |
| Ustekinumab | 6 |
| Belimumab | 5 |
| Golimumab | 5 |
| Tofacitinib | 4 |
| Certolizumab pegol | 3 |
| Ixekizumab | 3 |
| Risankizumab | 3 |
| Secukinumab | 3 |
| Tocilizumab | 3 |
| Guselkumab | 2 |
| Therapy changed | |
| Risankizumab | 1 |
| Unknown | |
| Adalimumab | 6 |
| Etanercept | 2 |
| Belimumab | 1 |
| Risankizumab | 1 |
| Ustekinumab | 1 |
3.12.5 Drugs of patients who did not complete safety screening within 2 years + 60 days of referral (larger category)
| Specialty Medication | Frequency |
|---|---|
| Lab error | |
| Baricitinib | 1 |
| Risankizumab | 1 |
| Noninitiation | |
| Risankizumab | 2 |
| Patient driven | |
| Belimumab | 1 |
| Certolizumab pegol | 1 |
| Etanercept | 1 |
| Ustekinumab | 1 |
| Provider driven | |
| Belimumab | 4 |
| Adalimumab | 2 |
| Ustekinumab | 2 |
| Secukinumab | 1 |
| Tocilizumab | 1 |
| Tofacitinib | 1 |
| Screening completed historically | |
| Adalimumab | 12 |
| Upadacitinib | 9 |
| Etanercept | 7 |
| Ustekinumab | 4 |
| Certolizumab pegol | 3 |
| Golimumab | 3 |
| Ixekizumab | 3 |
| Tofacitinib | 3 |
| Belimumab | 2 |
| Risankizumab | 2 |
| Tocilizumab | 2 |
| Guselkumab | 1 |
| Unknown | |
| Adalimumab | 5 |
| Risankizumab | 2 |
| Belimumab | 1 |
| Etanercept | 1 |
| Ustekinumab | 1 |
| Specialty Medication | Frequency |
|---|---|
| Noninitiation | |
| Risankizumab | 2 |
| Patient driven | |
| Baricitinib | 2 |
| Belimumab | 1 |
| Certolizumab pegol | 1 |
| Ustekinumab | 1 |
| Provider driven | |
| Adalimumab | 3 |
| Risankizumab | 1 |
| Ustekinumab | 1 |
| Screening completed historically | |
| Adalimumab | 21 |
| Upadacitinib | 12 |
| Etanercept | 9 |
| Ustekinumab | 6 |
| Belimumab | 5 |
| Golimumab | 5 |
| Tofacitinib | 4 |
| Certolizumab pegol | 3 |
| Ixekizumab | 3 |
| Risankizumab | 3 |
| Secukinumab | 3 |
| Tocilizumab | 3 |
| Guselkumab | 2 |
| Unknown | |
| Adalimumab | 6 |
| Etanercept | 2 |
| Belimumab | 1 |
| Risankizumab | 1 |
| Ustekinumab | 1 |
3.13 Time to fill from referral
| Characteristic | N | N = 737 |
|---|---|---|
| Days between referral and first fill | 517 | |
| Mean (SD) | 15.0 (19.1) | |
| Median (IQR) | 8.0 (4.0 - 17.0) | |
| Range | 0.0 - 115.0 | |
| Unknown | 220 |
3.14 Patients who did not start therapy
| Characteristic | N | N = 7371 |
|---|---|---|
| Did the patient start therapy? | 737 | |
| Yes | 643 (87.2%) | |
| Unsure | 50 (6.78%) | |
| No | 44 (5.97%) | |
| Reason for which patient did not start therapy | 44 | |
| Other | 21 (47.7%) | |
| Access/financial issues | 20 (45.5%) | |
| Safety screening results | 3 (6.82%) | |
| Unknown | 693 | |
| 1 n (%) | ||