Reference | Patient population | Study design | Drug | Groups and dosing regimens | Numbers of patients | Primary outcome | Results primary outcome | Relevant secondary outcomes | Results secondary outcomes |
---|---|---|---|---|---|---|---|---|---|
Mease et al., 2011 [12] | Psoriatic Arthritis | Randomized, double-blind, placebo-controlled Phase II trial | Abatacept | Group 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 months | ACR20 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 Arthritis | Randomized study; post-hoc analysis on data from the ACQUIRE and AMPLE studies | Abatacept | Group 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 Arthritis | Open label extension study; post hoc analysis of the J-RAPID and HIKARI trials | Certolizumab 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 activity | ACR20 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 Arthritis | Randomised double-blind phase III FUTURE 5 study | Secukinumab | Group 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 16 | ACR20 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 Spondylitis | Randomized placebo controlled trial MEASURE 4 study | Secukinumab | Group 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 weeks | ASAS20 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 |