Patients population | Trial name | Disease duration, years† | RF positivity, % | DMARDs failed, number, % | DMARD naïve, % | Taking steroids, % | CRP, mg/dL | ESR, mm/h | DAS28‡ | SJC, number/66 joints§ | HAQ DI | Total radiographic score |
---|---|---|---|---|---|---|---|---|---|---|---|---|
MTX naïve | US301/ULTRA | 6.5–7.0 | 59–65 | 0.8–0.9 | 40–45 | 53–55 | 1.9–2.5 | 33.8–38.4 | - | 13.0–14.8§ | 1.3 | 22.8–25.4 |
MN302 | 3.7–3.8 | 74–76 | 1.1 | 33–34 | 45–49 | 4.1–4.2 | 51.0–51.6 | - | 15.8–16.5§ | 1.5 | 24.6–24.9 | |
ERA | 1.0 | 87–89 | 0.5–0.6 | 54–61 | 39–42 | 3.3–4.4 | - | - | 24.0 | - | 11.2–12.9 | |
ASPIRE | 0.8–0.9 | 71–73 | 0.0 | 65–68 | 37–39 | 2.6–3.0 | 43.0–45.0 | 6.6–6.8 | 21.0–22.0 | 1.5 | 11.2–11.6 | |
PREMIER | 0.7–0.8 | 84–85 | - | 67–69 | 35–37 | 3.9–4.1 | - | 6.3–6.4 | 21.1–22.1 | 1.5–1.6 | 18.1–21.9 | |
COMET | 0.7–0.8 | 67–70¶ | - | 22–76 | 49–50 | 3.6–3.7 | 47.8–49.3 | 6.5 | 17.1–17.6 | 1.6-.17 | - | |
GO-BEFORE | 1.0–1.8 | 76–82 | - | 42–50 | 64–70 | 1.3–1.4 | 36.0–40.0 | 6.1–6.4 | 11.0–14.0 | 1.5–1.8 | 18.2–20.4 | |
IMAGE | 0.9–1.0 | 85–87 | - | 69–72 | 44–48 | 3.0–3.4 | - | 7.0–7.1 | 20.0–22.4 | 1.7–1.8 | 6.9–7.7 | |
OPTIMA | 4.0–4.5† | 87–89 | - | 89–90 | 41–46 | 2.7–3.0 | - | 6.0CRP | 18.0 | 1.6 | 11.2–11.8 | |
AGREE | 6.2–6.7† | 96–97 | - | 96–97 | 49–51 | 3.1–3.6 | - | 6.2–6.3CRP | 21.9–22.9 | 1.7 | 6.7–7.5 | |
HOPEFUL 1 | 0.3 | 83–85 | - | 43–53 | 30–34 | 2.9–3.1 | 59.9–61.8 | 6.6 | 16.5–17.3 | 1.1–1.3 | 13.6 | |
FUNCTION | 0.4–0.5 | 89–91 | - | 76–82 | 33–40 | 2.3–2.6 | 50.4–55.7 | 6.6–6.7 | 16.1–17.6 | 1.5–1.6 | 5.7–7.7 | |
PRIZE | 2.9–3.5† | 55–63 | - | 74–88 | 29–52 | 1.1–1.2 | - | 5.7–5.9 | 9.4–11.2 | 1.1–1.2 | 7.6–8.5 | |
ORAL Start | 2.7–3.4 | 82–84 | - | 60–63 | - | 2.0–2.6 | 53.4–56.0 | 6.5–6.6 | 15.6–16.8 | 1.5 | 16.1–19.1 | |
C-OPERA | 4.0–4.3† | 93–96 | - | 81–82 | 16–20 | 1.3–1.5 | 38.4–43.7 | 5.4–5.5 | 8.3–8.4§ | 1.0–1.1 | 5.2–6.0 | |
C-EARLY | 2.9† | 97 | 0.0 | 100 | 30–34 | 1.1 | 42.0–44.0 | 6.7–6.8 | 12.4–13.0§ | 1.6–1.7 | 7.2–8.5 | |
RA-BEGIN | 1.3–1.9 | 95–97 | 0.0 | 90–92 | 30–39 | 2.2–2.4 | 49.0–54.0 | 6.6 | 16.0 | 1.6–1.7 | 11.4–13.3 | |
MTX IR | European IL-1Ra | 3.7–4.3 | 69–71 | - | 19–34 | 41 | 4–4.2 | 46.8–53.2 | - | 25.6–26.6 | 1.5–1.6 | 24.7–29.6/12.0–16.6 |
ATTRACT | 9.0–12.0 | 77–84 | 2.5–2·8 | - | 54–65 | 3.3–4.2 | 49.0–52.0 | - | 21.0–24.0 | 1.7–1.8 | 66.6–81.9 | |
DE-O19 | 10.9–11.0 | 81–90 | 2.4 | - | - | 1.4–1.8 | - | - | 19.0–19.6 | 1.4 | 66.4–72.1 | |
AIM | 8.5–8.9 | 79–82 | - | 88–91 | 69–72 | 2.8–3.3 | - | 6.4 | 22.1–21.4 | 1.7 | 44.5–44.9 | |
LITHE | 9.0–9.4 | 81–83 | 1.6–1.7 | 22–19 | 62–70 | 2.1–2.3 | 45.9–46.5 | 6.5–6.6 | 16.6–17.3 | 1.5 | 28.5–28.7 | |
RAPID 1 | 6.1–6.2 | 80–84 | 1.3–1.4 | - | - | 1.4–1.6** | 42.5–45.0** | 6.9–7.0** | 21.2.21.7 | 1.7 | 27.0–27.5 | |
RAPID 2 | 5.6–6.5 | 76–78 | 1.2–1.3 | - | 55–62 | 1.3–1.4 | 39.1–43.7 | 6.8–6.9 | 20.5–21.9 | 1.6 | 39.6–46.7 | |
GO-FORWARD | 4.5–6.7** | 81–87 | - | - | 65–75 | 0.8–1.0** | 34.0–37.0** | 5.9–6.1** | 11.0–13.0** | 1.3–1.4** | 29.7–39.6** | |
GO-FORTH | 8.1–8.8 | - | - | - | - | 1.5–2.2 | - | 5.5–5.6 | 11.4–11.8 | 0.9–1.0 | 53.2–58.0 | |
CAMEO | 9.0–9.3 | 61–68 | 1.0 | - | 74–78 | 1.2–1.3 | 21.8–23.0 | 5.4–5.4 | 9.7–10.3§ | 1.3–1.5 | 37.9–38.2 | |
J-RAPID | 5.6–6.0 | 86–90 | 1.7–1.8 | - | 60–69 | 1.3–1.6 | 44.5–49.0 | 6.2–6.5 | 16.6–18.4 | 1.1–1.2 | 49.9–54.8 | |
ACT-RAY | 8.2–8.3 | - | 1.9 | - | 49 | - | 6.3–6.4 | 14.4–15.3 | 1.5 | 30.4–37.1 | ||
ORAL-SCAN | 8.8–9.5 | 75–80 | - | 24–42 | - | 1.2–1.7 | 47.8–54.5 | 6.2–6.3 | 14.1–14.5 | 1.2–1.4 | 30.1–37.3 | |
GO-FURTHER | 6.9–7.0 | 100.0†† | - | 0 | - | 2.2–2.8 | - | 5.9–6.0CRP | 14.8–15.0 | 1.6–1.6 | 47.6–50.3 | |
AMPLE | 1.7–1.9 | 76–77 | - | 0 | 50–51 | 1.5–1.6 | - | 5.5CRP | 15.8–15.9 | 1.5 | 24.2–24.8 | |
DRIVE | 2.2–2.3 | 67–69 | - | 74–82 | 42–45 | 0.5–0.8 | - | 3.6–4.0CRP | 8.9–10.5 | 0.3–0.5 | 10.0–13.6 | |
PLANETRA | 1.7–1.9 | 72–75 | - | 0 | - | 1.9 | 46.6–48.5 | 5.8–5.9 | 15.2–16.2 | 1.6 | 68.3–64.8 | |
MOBILITY | 8.6–9.5 | 83–87 | - | 0 | 63–67 | 2.0–2.4 | - | 5.9–6.0CRP | 16.6–16.8 | 1.6–1.7 | 46.3–54.7 | |
RA-BEAM | 10.0 | 90–91 | - | 0 | 56–61 | 2.0–2.2 | 48.0–49.0 | 6.4–6.5 | 15.0–16.0 | 1.55–1.59 | 43.0–45.0 | |
SB4 | 6.0–6.2 | 78–79 | - | 0 | - | 1.3–1.5 | 46.4–46.5 | 6.5 | 15.0–15.4 | 1.49–1.51 | 38.9–43.3 | |
SB2 | 6.3–6.6 | 71–74 | - | 0 | - | 1.6–1.4 | 44.5–46.7 | 6.5 | 14.6–14.9 | 1.5 | 37.1–38.9 | |
RAJ4 | 4.3–4.4 | - | - | 0 | - | 2.5–2.6 | 51.0–53.8 | 5.8–6.1 | 6.8–7.0 | 0.91–1.05 | 25.0–28.4 | |
SELECT-COMPARE | 8.0 | 87–88 | - | 0 | 60–62 | 1.8–2.0 | - | 6.4–6.5 | 16.0–17.0 | 1.6 | 34.0–36.0 | |
MN301 | 5.7–7.6 | 76–83 | 0.8–1.0 | 40–53 | 45–46 | 3.4–4.5 | 50.5–55.7 | - | 15.3–16.2§ | 1.7–1.9 | 41.9–46.3 | |
DMARD IR | TEMPO | 6.3–6.8 | 71–76 | 2.3 | 0 | 57–64 | 2.5–3.2 | - | 5.5–5.7 | 22.1–23.0 | 1.8 | 28.8–35.5 |
SAMURAI | 2.2–2.4 | 51 | 2.7–2.8 | 35 | - | 4.7–4.9 | 70.8–71.0 | 6.4–6.5 | 11.9–12.5 | - | 28.3–30.6 | |
GO-MONO | 8.1–9.4 | - | 0 | - | 2.2–2.6 | - | 5.8–6.0 | 12.6–13.1 | 1.0–1.1 | 43.8–56.9 | ||
HIKARI | 5.4–5.8 | 85–89 | 1.8–1.9 | 0 | 66–71 | 1.6–1.7 | 49.0–51.0 | 6.1–6.3 | 13.8–15.5 | 1.1–1.2 | 36.5–46.1 | |
J-ETA | 2.9–3.0 | 76–78 | - | 0 | 60–67 | 2.1–2.3 | 42.0–43.7 | 5.7–5.8 | 13.8–14.2 | 1.0–1.2 | 25.1–31.4 | |
BREVACTA | 11.1–11.1 | 81–82 | 1.3–1.4 | 0 | - | 1.9–2.0 | 49.4–50.9 | 6.6–6.7 | 17.5–17.6 | 1.6–1.6 | 59.0–60.4 | |
SURROUND-D | 8.3–8.8 | 78–80 | - | 0 | 59–65 | 2.4–2.5 | - | - | - | 1.5–1.6 | 41.8–42.5 | |
RA-BUILD | 7.0–8.0 | 75–77 | - | 0 | 50–51 | 1.4–1.8 | 23.0–25.0 | 6.2–6.3 | 13.0–14.0 | 1.5–1.6 | 19.0–26.0 | |
TNFi IR | REFLEX | 11.7–12.1 | 79 | 2.4–2.6 | 0 | 61–65 | 3.7–3.8 | 48.0–48.4 | 6.8–6.9 | 22.9–23.4 | 1.9–1.8 | 47.9–48.3 |
ADMIRE | 7.6–10.4** | 69–92 | 2.0 | 0 | - | 1.7–2.1** | - | 2.1–1.7** | - | 0.1–0.4** | 22.5–42.5** | |
REASSURE | 7.8–9.0 | 91–94 | - | 0 | 58–62 | - | - | 5.6–5.7 | 16.4–17.2 | 1.7 | 48.1–57.7 |
*Values were expressed in mean unless otherwise indicated. The range of values was from the minimum to maximum, incorporating all study arms.
†If the disease duration was expressed as months, it is indicated.
‡ DAS28 was based on the ESR.
§If the swollen-joints count was based on 28 joint examinations, it is indicated.
¶ This value meant anti-citrullinated protein antibody positivity.
**Values were expressed in median.
††This trial included patients who was positive either in rheumatoid factor or anti-citrullinated protein antibody.
CRP, C reactive protein; DAS28, the 28-joint disease activity score; DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; HAQ-DI, health assessment questionnaire-disability index; IR, inadequate responder; MTX, methotrexate; RF, rheumatoid factor; SB2, biosimilar of infliximab; SB4, biosimilar of etanercept; SJC, swollen joints count; TNF, tumour necrosis factor.