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Table 2 Included references and results

From: The pharmacological and clinical aspects behind dose loading of biological disease modifying anti-rheumatic drugs (bDMARDs) in auto-immune rheumatic diseases (AIRDs): rationale and systematic narrative review of clinical evidence

ReferencePatient populationStudy designDrugGroups and dosing regimensNumbers of patientsPrimary outcomeResults primary outcomeRelevant secondary outcomesResults secondary outcomes
Mease et al., 2011 [12]Psoriatic ArthritisRandomized, double-blind, placebo-controlled Phase II trialAbataceptGroup 1: 3 mg/kg at days 1, 15, and 29, every 4 weeks thereafter
Group 2: 10 mg/kg at days 1, 15, and 29, every 4 weeks thereafter
Group 3: 30 mg/kg at days 1 and 15, 10 mg/kg at day 29 and every 4 weeks thereaftera
Group 1: 43
Group 2: 40
Group 3: 45
ACR20 at 6 monthsACR20
Group 1: 33%
Group 2: 48%
Group 3: 42%
No significant differences reported between the groups (especially groups 2 and 3)
HAQ-DI
SF-36
ACR50
ACR70
Damage of joints on MRI
AE’s
No significant differences reported between the groups (especially groups 2 and 3)
Schiff et al., ACR meeting 2012 [11]Rheumatoid ArthritisRandomized study; post-hoc analysis on data from the ACQUIRE and AMPLE studiesAbataceptGroup 1: s.c. 125 mg/week (ACQUIRE)
Group 2: s.c. 125 mg/week, plus i.v. loading dose 10 mg/kg on day 1 (AMPLE)
Group 1: 736 (ACQUIRE)
Group 2: 318 (AMPLE)
ACR20 at weeks 2, 4, 8, 12, 16, 20, 24.ACR20 at weeks 2, 4, 8, 12, 16, 20, 24
Group 1: 27.4, 42.5, 58.5, 60.1, 66.0, 70.1, 66.0%
Group 2:24.6, 44.5, 58.0, 66.6, 69.3, 72.4, 74.8%
No significant difference between the groups
HAQ-DI at weeks 2, 4, 8, 12, 16, 20, 24
Changes in DAS28 CRP from baseline over 6 months
No significant difference between the groups
Takeuchi et al., Mod Rheumatol 2016 [10]Rheumatoid ArthritisOpen label extension study; post hoc analysis of the J-RAPID and HIKARI trialsCertolizumab pegol (CZP)Group 1: 400 mg loading dose at weeks 0, 2, and 4, then 200 mg Q2W thereafter
Group 2: 200 mg Q2W
Group 1: 198
Group 2: 160
ACR20 at weeks 4, 8, 12, 16, 20, 24% Low disease activityACR20 at week 4
Group 1: 62.2 and 67.2%
Group 2: 57.1 and 49.5%
ACR20 at week 8
Group 1: 82.9 and 71.6%
Group 2: 69.6 and 61.1%
Absolute values for week 12, 16, 20, and 24 were not provided; graphical presentation only.
No statistical data providedb
Not well defined in methods section, but reported for: ACR50,70 responses
% Low disease activity (LDA) at weeks 12 and 24
Plasma concentrations of CZP and antibodies against CZP
Adverse Events rates
Loading dose groups showed faster ACR responses followed by sustained ACR responses up to 24 weeks compared to patients who did not receive loading dose.
Higher levels of antibodies in group without loading dose.
Similar adverse event rates.
No statistical data provided♠
Mease et al., Ann Rheum Dis, 2018 [13]Psoriatic ArthritisRandomised double-blind phase III FUTURE 5 studySecukinumabGroup 1:
150 mg s.c. with loading dose, at weeks 0, 1, 2, 3 and 4, then every 4 weeks thereafter
Group 2: 150 mg s.c. without loading dose, at weeks 0, (at 1, 2, 3 placebo) and 4, then every 4 weeks thereaftera
Group 1: 222
Group 2: 220
ACR20 at week 16ACR20 response at week 16
Group 1: 55.5%
Group 2: 59.5%
No statistical difference between loading versus no loading
Radiographic progression at week 24 (van der Heijde-modified total Sharp score)
HAQ-DI
DAS28-CRP
ACR50/70 response
Proportion of patients achieving MDA at week 16
AE’s and SAE’s
No statistical difference between loading versus no loading
Kivitz et al., Rheumatol Ther, 2018 [14]Ankylosing SpondylitisRandomized placebo controlled trial
MEASURE 4 study
SecukinumabGroup 1: 150 mg at week 0 and every 4 weeks thereafter, with loading dose 150 mg at weeks 1, 2, and 3
Group 2: 150 mg at week 0 and every 4 weeks thereafter, with placebo at weeks 1, 2, and 3
Group 1: 116
Group 2: 117
ASAS20 at 16 weeksASAS20 at 16 weeks
Group 1: 59.5%
Group 2: 61.5%
No significant difference.
ASAS20 at 52, and 104 weeks
ASAS40 at 16 weeks
% achieving ASAS20 and ASAS40
Change from baseline in BASDAI % AEs, % SAEs
No significant difference
  1. a Placebo groups were removed from the table [12, 13]
  2. b Exact patient numbers in each group at each time point could not be extracted from the manuscript for post hoc statistical analysis
  3. Abbreviations:
  4. ACR American College of Rheumatology (ACR20 means 20% improvementin tender or swollen joint counts as well as 20% improvement in three of the other five criteria; ACR50 70 analogous)
  5. HAQ-DI Health Assessment Questionnaire, Disability Index
  6. SF36 Short Form 36
  7. ASAS Assessment in Spondyloarthritis International Society
  8. Q2W Every two weeks
  9. DAS28 CRP Disease Activity Score based on 28 joints and C-reactive protein
  10. BASDAI Bath Ankylosing Spondylitis Disease Activity Index
  11. MDA Minimal Disease Activity
  12. (S)AE (Serious) Adverse Events
  13. CZP Certolizumab pegol