Table 2 Adult Spondyloarthropathy literature evaluating Adalimumab withdrawal, flare rates, recapture method and success rates
First Author | Michielsens | Wetterslev | Kwon | Gratacós | Landewé | Fong |
Year | 2022 | 2022 | 2021 | 2019 | 2018 | 2016 |
Study Design | RCT non inferiority | Prospective cohort-registry | Retrospective cohort | RCT | RCT | Retrospective cohort |
Sites | 1 | NA | 1 | 22 | 107 | 1 |
Enrolled (N) | 122 | 107 | 101 | 120 | 305 | 208 |
ADA specific taperb | 62 (76%) | 62 (58%) | 101 (100%) | 23 (40%) | 140 (100%) | 104 (50%) |
Tapering method | Prolonged dosing interval | Dose reduction | Average dose quotients | Prolonged dosing interval | Abrupt stop | Prolonged dosing interval |
Study Duration (months) | 12 | 24 | 50 | 12 | 10 | 30 |
Lowest ADA dose | No ADA | No ADA | NA | 40Â mg Q3 weeks | no ADA | 40Â mg Q3 weeks |
CID/LDA definition | PsA LDA: PASDAS ≤ 3.2 & mBSA ≤ 3% AS LDA: ASDAS < 2.1 | BASDAI < 40; PGA VAS < 40; physician stated remission at time of enrollment; low disease activity on DANBIO (Danish registry) review for the prior year | BASDAI ≤ 4 | BASDAI ≤ 2 and no clinically active arthritis or enthesitis and no CRP equal to or higher than the upper limit of normality for ≥ 6 months | ASDAS inactive disease score (< 1.3) at weeks 16, 20, 24, and 28 during open-label lead-in period | BASDAI < 4 for 56 months and not taking NSAIDs regularly |
Patient reported assessments | PASDAS, ASDAS | BASDAI, BASFI, HAQ, HAQ-S, EQ-5D, ASAS HI, patient VAS for pain/fatigue/global | BASDI | ASDAS-CRP, BASDAI, VAS nocturnal axial pain | HAQ-S | BASDAI, DAS28-ESR |
Background therapy | csDMARDS maintained, primarily MTX, leflunomide, NSAID | NA | Mixed, some on csDMARDs and NSAIDs | NA | csDMARDs, NSAIDs, steroids | Mixed; some csDMARDs |
Flare Rates | Taper:69% (56/81) Continue:73% (30/41) (p = 0.32) | Taper: 100% (106/107) 27% (29) 2/3 dose 19% (21) 1/2 dose 27% (29) 1/3 dose 26% (28) stop | Taper: 44.6% (45/101) | Taper: 21.8% (13/58) Continue: 16.3% (8/55) | Stop: 53% (81/153) Continue: 29% (42/144) | Taper: 42% (20/48) AS: 42.4% (14/33) PSA: 40% (6/15) |
Recapture method | Return to last effective dose of TNFi | 4Â week NSAID or steroid trial, if no response then return to last effective dose | ADA standard dosing | NA | ADA standard dosing | Restart previous medication |
Recapture results | 78%(18/23) | 97% (104/107) | 91.1% (41/45) | NA | 57% (37/65) at 12Â weeks | 100% (48/48)a |
Factors associated with successful discontinuation | none | Physician global VAS < 40 before medication change | Longer duration in LDA (> 5.3 months), higher average dose quotient (> 60%) | BASFI, lower hs-CRP | Lower ASDAS (0–1.3) | Lower disease activity in PsA patients |
Evidence quality | 1 | 2 | 2 | 1 | 1 | 2 |
First Author | C. Plasencia | A. Moverley | S. Arends | M. Almirall | H. Haibel | F. Cantini |
Year | 2015 | 2015 | 2015 | 2015 | 2013 | 2012 |
Study Design | Retrospective cohort | RCT | Prospective cohort | Prospective cohort | Secondary analysis | Case control |
Sites | 2 | 2 | 2 | 1 | 2 | 1 |
Enrolled (N) | 117 | 17 | 58 | 42 | 46 | 131 |
ADA specific taperb | 17 (23%) | 5 (45%) | 9 (16%) | 27 (64%) | 24 (100%) | 53 (100%) |
Tapering method | Prolonged dosing interval | Prolonged dosing interval | Prolonged dosing interval | Prolonged dosing interval | Prolonged dosing interval | Prolonged dosing interval |
Study Duration (months) | 12 | 3 | 24 | 12 | 24 | 36 |
Lowest ADA dose | 40Â mg Q6 weeks | no ADA | 40Â mg Q4 weeks | 40Â mg Q3 weeks | no ADA | 40Â mg Q4 weeks |
CID/LDA definition | LDA or remission DAS28 < 3.2 for 6 months prior to taper | LDA: MDA criteria, stable disease for proceeding 6 months as indicated by treating physician | LDA: BASDAI < 4, ASDAS < 2.1 and CRP < 5 mg/L CID: ASDAS < 1.3 | LDA: BASDAI between 2 and 4 units, allowing peripheral disease and increased CRP levels | LDA: ASAS40 | CID: psoriatic: 6 M of no fatigue or pain, no symptoms, normal CRP/ ESR psoriatic spondylitis:6 M of BASDAI ≤ 4, no joint symptoms, normal CRP/ESR. No NSAIDs or corticosteroids for 2 visits |
Patient reported assessments | NA | VAS, SF36, HAQ | ASQoL | NA | ASDAS, SF-36 (physical, mental component), BASFI, pain scores | NA |
Background therapy | No background therapy for ADA; for overall group, some on MTX | Mixed; some MTX | Mixed; some NSAIDs and csDMARDs | Mixed; some csDMARDs | NA | Mixed; some were taking MTX |
Flare Rates | Taper: 30% (22/74) ADA: 11.8% (2/17) | Taper: 54.6% (6/11) Continue: 0% (0/6) | Overall: 47% (27/58) ADA: 44% (4/9) | Overall: 23.8% (10/42) ADA: 22.2% (6/27) | ADA: 79% (19/24) | ADA: 11.3% (6/53) |
Recapture method | Restart previous medication | NA | Restart previous medication | NA | ADA standard dosing | ADA standard dosing |
Recapture results | 100% (2/2) | NA | most—(n) not reported | NA | 63% (12/19) at 1 yr 73% (15/20) at 2 yr | 100% (6/6) |
Factors associated with successful discontinuation | Male sex | NA | Lower ASQoL | Longer disease duration, biologic treatment duration, and remission duration | NA | NA |
Evidence quality | 2 | 2 | 2 | 2 | 1 | 3 |