5-Year Efficacy and Safety Results of TCZ Monotherapy in Patients Who Were Part of the AMBITION Study

29 Oct, 20

Introduction

AMBITION (Actemra versus Methotrexate double-blind Investigative Trial In mONotherapy) was a 24-week, randomized controlled trial in patients with active rheumatoid arthritis (RA) who were either methotrexate (MTX)-naive or MTX-free. The study showed the clinical efficacy and superiority of a biologic monotherapy compared with MTX monotherapy for typical MTX dosing regimens

Aim

To report long-term efficacy and safety of tocilizumab (TCZ) monotherapy in patients who were part of the AMBITION study

Patient Profile

Patients with active RA who were methotrexate- and biologic-naive or free

of methotrexate for 6 Months

Methods

LTE= longterm extension study ;TCZ=tocilizumab;MTX=methotrexate

^*patients at Week 24 who achieved ≥ 50% improvement from baseline in the tender joint count (TJC) and swollen joint count (SJC) at weeks 20 and 24 could opt to continue their current blinded treatment in a transition phase until the last patient from AMBITION completed the 24-week core study, or they could move into the LTE study at any time during the transition phase if ≥ 50% improvement in active TJC and SJC was not maintained

Efficacy assessments included the Disease Activity Score at 28 joints (DAS28), American College of Rheumatology (ACR) 20/50/70 responses, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI).
Remission was defined as DAS28 < 2.6, SDAI ≤ 3.3, or CDAI ≤ 2.8.

Results

Table 1: Baseline demographics of TCZ monotherapy patients who transitioned to LTE. Values are mean (SD) unless otherwise specified.

Demographic	TCZ Monotherapy, n = 134
Demographic	TCZ Monotherapy, n = 134
Age, yrs	51.1 (12.3)
Female, n (%)	111 (82.8)
Baseline oral corticosteroid use, n (%)	60 (44.8)
No. previous DMARD	0.9 (1.0)
No. previous anti-TNF	0.1 (0.3)
RA duration, yrs	5.9 (7.4)
CRP, mg/dl	3.0 (3.3)
ESR, mm/h	51.3 (26.0)
TJC68	32.3 (14.3)
SJC66	18.7 (9.9)
VAS PtGA, mm*	62.5 (19.2)
DAS28*	6.8 (0.9)

RA: rheumatoid arthritis; CRP: C-reactive protein; ESR: erythrocyte sedimentation rate; TJC68: tender joint count at 68 joints; SJC66: swollen joint count at 66 joints; VAS: visual analogue scale; PtGA: patient’s global assessment; DAS28: Disease Activity Score at 28 joints

Clinical efficacy and superiority of a biologic monotherapy compared with MTX monotherapy for typical MTX dosing regimens
The 5-year efficacy results confirm the continued effectiveness and safety of TCZ as monotherapy

Figure 1: Long-term efficacy results showed that efficacy was maintained or improved for up to 264 weeks in patients receiving TCZ monotherapy

The risk for serious infections remained stable over time in the AMBITION LTE
No new safety signals were reported

Conclusion

In AMBITION study, 264 weeks of TCZ therapy showed the continuing efficacy and safety that was consistent with the efficacy and safety results of 7 other TCZ monotherapy studies
The findings suggested a sustained effect even without MTX
TCZ monotherapy for long-term treatment of RA is an important option for patients who are unable to tolerate MTX or for whom MTX is otherwise inappropriate

Reference

J Rheumatol 2017; 44:142–6