Table 5.
Incidences of rare safety events during the placebo-controlled period and up to week 160: pooled data from phase IIb and phase III studies of SC golimumab in rheumatological indications (RA, PsA and AS)
| Placebo-controlled period* | Week 160 | |||||
|---|---|---|---|---|---|---|
| Placebo±MTX | Golimumab 50 mg±MTX | Golimumab 100 mg±MTX | Placebo±MTX | Golimumab 50 mg±MTX | Golimumab 100 mg±MTX | |
| Number of treated patients† | 674 | 750 | 1044 | 674 | 1317 | 1571 |
| Death, n (%) | 1 (0.1) | 1 (0.1) | 3 (0.3) | 1 (0.1) | 7 (0.5) | 14 (0.9) |
| Incidence per 100 pt-yrs (95% CI) | 0.32 (0.01 to 1.79) | 0.27 (0.01 to 1.53) | 0.52 (0.11 to 1.53) | 0.28 (0.01 to 1.56) | 0.30 (0.12 to 0.62) | 0.41 (0.23 to 0.69) |
| Serious infection, n (%) | 17 (2.5) | 12 (1.6) | 27 (2.6) | 17 (2.5) | 57 (4.3) | 117 (7.4) |
| Incidence per 100 pt-yrs (95% CI) | 5.50 (3.21 to 8.81) | 3.31 (1.71 to 5.78) | 4.76 (3.14 to 6.92) | 5.31 (3.20 to 8.30) | 3.03 (2.36 to 3.82) | 5.09 (4.36 to 5.90) |
| Tuberculosis, n (%) | 0 (0.0) | 2 (0.3) | 0 (0.0) | 0 (0.0) | 4 (0.3) | 12 (0.8) |
| Incidence per 100 pt-yrs (95% CI) | 0.00 (0.00 to 0.96) | 0.55 (0.07 to 1.98) | 0.00 (0.00 to 0.52) | 0.00 (0.00 to 0.84) | 0.17 (0.05 to 0.44) | 0.35 (0.18 to 0.62) |
| Opportunistic infection, n (%)‡ | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) | 3 (0.2) | 8 (0.5) |
| Incidence per 100 pt-yrs (95% CI) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 0.82) | 0.17 (0.00 to 0.97) | 0.00 (0.00 to 0.84) | 0.13 (0.03 to 0.38) | 0.24 (0.10 to 0.46) |
| Malignancy | ||||||
| All malignancies, n (%) | 6 (0.9) | 3 (0.4) | 10 (1.0) | 7 (1.0) | 29 (2.2) | 38 (2.4) |
| Incidence per 100 pt-yrs (95% CI) | 1.93 (0.71 to 4.21) | 0.82 (0.17 to 2.41) | 1.75 (0.84 to 3.21) | 1.97 (0.79 to 4.05) | 1.26 (0.84 to 1.81) | 1.13 (0.80 to 1.55) |
| SIR (95% CI)§ vs SEER database | 1.07 (0.13 to 3.87) | 0.97 (0.12 to 3.49) | 1.25 (0.34 to 3.21) | 0.94 (0.11 to 3.38) | 1.48 (0.89 to 2.31) | 0.99 (0.61 to 1.53) |
| Non-melanoma skin cancer, n (%) | 4 (0.6) | 1 (0.1) | 6 (0.6) | 5 (0.7) | 10 (0.8) | 18 (1.1) |
| Incidence per 100 pt-yrs (95% CI) | 1.29 (0.35 to 3.30) | 0.27 (0.01 to 1.53) | 1.05 (0.38 to 2.28) | 1.40 (0.46 to 3.28) | 0.43 (0.21 to 0.80) | 0.53 (0.32 to 0.84) |
| Lymphoma, n (%) | 0 (0.0) | 0 (0.0) | 2 (0.2) | 0 (0.0) | 1 (0.08)¶ | 6 (0.4)** |
| Incidence per 100 pt-yrs (95% CI) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 0.82) | 0.35 (0.04 to 1.26) | 0.00 (0.00 to 0.84) | 0.04 (0.00 to 0.24) | 0.18 (0.06 to 0.38) |
| SIR (95% CI)§ vs SEER database | 0.00 (0.00 to 36.43) | 0.00 (0.00 to 32.66) | 14.13 (1.71 to 51.03) | 0.00 (0.00 to 31.98) | 1.71 (0.04 to 9.55) | 6.69 (2.45 to 14.56) |
| Demyelinating disorder, n (%) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 3 (0.2) |
| Incidence per 100 pt-yrs (95% CI) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 0.82) | 0.17 (0.00 to 0.97) | 0.00 (0.00 to 0.84) | 0.00 (0.00 to 0.13) | 0.12 (0.03 to 0.30) |
*The controlled study period could extend up to week 52 per trial design.
†Patients may appear in ≥1 treatment column.
‡Identified events included histoplasmosis, listeria sepsis, oesophageal candidiasis, pneumonia legionella, coccidioidomycosis, eye infection toxoplasmal, Pneumocystis jiroveci pneumonia and Mycobacterium kansasii infection.
§95% CIs not containing 1 (in bold) indicate a significant difference from the SEER database.
¶This patient had AS.
**All six patients had RA. Two patients were diagnosed with lymphoma during the placebo-controlled period; the other four were diagnosed with lymphoma after the placebo-controlled period and by week 160.
AS, ankylosing spondylitis; MTX, methotrexate; PsA, psoriatic arthritis; pt-yrs, patient-years; RA, rheumatoid arthritis; SC, subcutaneous; SEER, Surveillance, Epidemiology and End Results; SIR, standardised incidence ratio.