TABLE 3.
Signal strength of reports of secukinumab at the Preferred Term (PT) level in the FAERS database.
| SOC | Preferred terms (PTs) | Secukinumab cases reporting PT | ROR (95%two-sided CI) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|
| Eye disorders | Uveitis | 281 | 5.90 (5 23–6.65) | 5.88 (1077.70) | 2.49 (2.28) | 5.62 (4.98) |
| Gastrointestinal disorders | Irritable bowel syndrome | 245 | 3.56 (3.14–4.05) | 3.55 (435.15) | 1.79 (1.59) | 3.47 (3.05) |
| Inflammatory bowel disease | 224 | 11.10 (9.67–12.75) | 11.08 (1854.59) | 3.34 (3.07) | 10.1 (8.80) | |
| Mouth ulceration | 189 | 2.35 (2.03–2.71) | 2.34 (142.66) | 1.21 (0.98) | 2.31 (2.00) | |
| Aphthous ulcer | 131 | 3.54 (2.98–4.22) | 3.54 (230.92) | 1.79 (1.49) | 3.46 (2.90) | |
| Drug ineffective | 13,472 | 2.40 (2.35–2.44) | 2.19 (9132.22) | 1.11 (1.09) | 2.16 (2.12) | |
| Pain | 6,372 | 2.73 (2.66–2.80) | 2.61 (6326.11) | 1.36 (1.32) | 2.57 (2.50) | |
| Therapeutic product effect incomplete | 2,314 | 4.00 (3.84–4.17) | 3.92 (4886.46) | 1.93 (1.87) | 3.82 (3.66) | |
| Injection site bruising a | 1,204 | 3.47 (3.28–3.68) | 3.44 (2022.96) | 1.75 (1.66) | 3.36 (3.17) | |
| Inflammation | 922 | 4.95 (4.63–5.29) | 4.91 (2745.91) | 2.24 (2.14) | 4.73 (4.43) | |
| Illness | 600 | 3.39 (3.13–3.68) | 3.38 (974.85) | 1.72 (1.60) | 3.30 (3.04) | |
| Therapeutic response shortened | 595 | 7.60 (6.99–8.27) | 7.56 (3157.82) | 2.83 (2.69) | 7.11 (6.54) | |
| Concomitant disease aggravated | 320 | 9.84 (8.77–11.04) | 9.81 (2312.37) | 3.18 (2.97) | 9.04 (8.06) | |
| Therapeutic product effect delayed | 155 | 3.50 (2.98–4.11) | 3.50 (267.47) | 1.77 (1.50) | 3.42 (2.91) | |
| Tenderness | 146 | 3.41 (2.89–4.02) | 3.40 (239.69) | 1.73 (1.46) | 3.32 (2.82) | |
| Secretion discharge a | 144 | 2.62 (2.22–3.09) | 2.62 (140.45) | 1.37 (1.10) | 2.58 (2.18) | |
| Symptom recurrence | 106 | 10.18 (8.34–12.43) | 10.17 (797.44) | 3.22 (2.81) | 9.34 (7.65) | |
| Immune system disorders | Decreased immune responsiveness | 497 | 12.62 (11.49–13.85) | 12.55 (4711.97) | 3.50 (3.33) | 11.30 (10.29) |
| Immune system disorder | 201 | 3.50 (3.04–4.03) | 3.50 (346.84) | 1.77 (1.54) | 3.42 (2.97) | |
| Infections and infestations | Nasopharyngitis | 3,014 | 3.97 (3.83–4.12) | 3.87 (6235.37) | 1.91 (1.86) | 3.76 (3.63) |
| Influenza | 1,606 | 3.31 (3.15–3.48) | 3.27 (2467.92) | 1.68 (1.60) | 3.20 (3.04) | |
| Sinusitis | 1,541 | 3.72 (3.53–3.92) | 3.67 (2908.82) | 1.84 (1.76) | 3.58 (3.40) | |
| Infection | 1,334 | 2.30 (2.18–2.43) | 2.28 (944.42) | 1.17 (1.09) | 2.25 (2.13) | |
| COVID-19 a | 1,267 | 4.11 (3.88–4.35) | 4.06 (2823.94) | 1.98 (1.89) | 3.95 (3.73) | |
| Lower respiratory tract infection | 942 | 4.83 (4.53–5.16) | 4.79 (2707.23) | 2.21 (2.11) | 4.62 (4.33) | |
| Bronchitis | 774 | 2.34 (2.17–2.51) | 2.32 (573.13) | 1.20 (1.09) | 2.29 (2.14) | |
| Upper respiratory tract infection | 747 | 3.85 (3.58–4.14) | 3.82 (1505.86) | 1.90 (1.78) | 3.72 (3.46) | |
| Cellulitis | 672 | 3.16 (2.93–3.41) | 3.14 (955.38) | 1.62 (1.50) | 3.08 (2.85) | |
| Ear infection | 481 | 4.66 (4.25–5.11) | 4.64 (1316.04) | 2.16 (2.02) | 4.48 (4.09) | |
| Fungal infection | 408 | 2.81 (2.54–3.10) | 2.80 (459.62) | 1.46 (1.30) | 2.75 (2.49) | |
| Candida infection | 364 | 4.57 (4.11–5.07) | 4.55 (966.93) | 2.14 (1.97) | 4.40 (3.96) | |
| Staphylococcal infection | 361 | 2.93 (2.63–3.25) | 2.92 (443.26) | 1.52 (1.35) | 2.87 (2.58) | |
| Localised infection | 319 | 2.97 (2.65–3.32) | 2.96 (402.68) | 1.54 (1.36) | 2.90 (2.60) | |
| Respiratory tract infection | 318 | 2.91 (2.60–3.25) | 2.90 (385.03) | 1.51 (1.33 | 2.85 (2.55) | |
| Oral candidiasis | 317 | 6.78 (6.05–7.60) | 6.76 (1461.78) | 2.68 (2.48) | 6.41 (5.72) | |
| Viral infection | 315 | 2.39 (2.13–2.67) | 2.38 (247.05) | 1.23 (1.06) | 2.35 (2.10) | |
| Pharyngitis streptococcal | 268 | 6.55 (5.79–7.41) | 6.53 (1181.49) | 2.63 (2.42) | 6.20 (5.48) | |
| Kidney infection a | 250 | 2.91 (2.57–3.30) | 2.91 (304.03) | 1.51 (1.31) | 2.85 (2.52) | |
| Pharyngitis | 226 | 4.34 (3.80–4.96) | 4.33 (555.87) | 2.07 (1.85) | 4.20 (3.67) | |
| Oral herpes | 224 | 2.86 (2.50–3.26) | 2.85 (262.36) | 1.49 (1.27) | 2.80 (2.45) | |
| Tuberculosis | 188 | 3.70 (3.20–4.28) | 3.69 (356.55) | 1.85 (1.61) | 3.60 (3.11) | |
| Tonsillitis | 173 | 8.08 (6.92–9.44) | 8.07 (994.01) | 2.92 (2.63) | 7.56 (6.47) | |
| Tooth abscess | 169 | 3.95 (3.39–4.60) | 3.94 (357.59) | 1.94 (1.68) | 3.83 (3.29) | |
| Eye infection | 160 | 3.50 (2.99–4.09) | 3.49 (275.38) | 1.77 (1.51) | 3.41 (2.91) | |
| Skin infection | 142 | 3.03 (2.56–3.58) | 3.02 (186.78) | 1.57 (1.29) | 2.96 (2.51) | |
| Erysipelas | 142 | 6.65 (5.61–7.88) | 6.64 (639.16) | 2.65 (2.34) | 6.30 (5.31) | |
| Tooth infection | 141 | 2.61 (2.21–3.08) | 2.61 (136.21) | 1.36 (1.09) | 2.57 (2.17) | |
| Rhinitis | 135 | 4.12 (3.47–4.89) | 4.11 (305.82) | 2.00 (1.70) | 3.99 (3.36) | |
| Furuncle | 129 | 3.85 (3.23–4.59) | 3.85 (262.10) | 1.90 (1.60) | 3.74 (3.14) | |
| Coronavirus infection | 119 | 3.43 (2.86–4.12) | 3.43 (198.47) | 1.75 (1.44) | 3.35 (2.79) | |
| Laryngitis | 114 | 2.70 (2.24–3.25) | 2.70 (118.93) | 1.41 (1.10) | 2.66 (2.21) | |
| Investigations | C-reactive protein increased | 357 | 2.68 (2.42–2.98) | 2.68 (366.02) | 1.40 (1.23) | 2.63 (2.37) |
| SARS-CoV-2 test positive | 151 | 4.29 (3.65–5.05) | 4.29 (365.29) | 2.05 (1.78) | 4.15 (3.53) | |
| Musculoskeletal and connective tissue disorders | Arthralgia a | 5,682 | 3.63 (3.53–3.73) | 3.46 (9788.63) | 1.76 (1.72) | 3.38 (3.29) |
| Psoriatic arthropathy | 2,541 | 19.96 (19.12–20.84) | 19.42 (37410.46) | 4.04 (3.97) | 16.50 (15.80) | |
| Arthritis | 1,672 | 5.37 (5.11–5.65) | 5.29 (5554.55) | 2.35 (2.27) | 5.08 (4.84) | |
| Musculoskeletal stiffness a | 1,381 | 3.82 (3.61–4.03) | 3.77 (2725.03) | 1.88 (1.79) | 3.67 (3.48) | |
| Joint swelling | 1,280 | 2.65 (2.50–2.80) | 2.62 (1261.42) | 1.37 (1.28) | 2.58 (2.44) | |
| Ankylosing spondylitis | 724 | 18.44 (17.04–19.96) | 18.30 (10057.30) | 3.97 (3.83) | 15.69 (14.49) | |
| Neck pain | 597 | 2.60 (2.39–2.82) | 2.59 (568.61) | 1.35 (1.22) | 2.55 (2.35) | |
| Joint stiffness a | 390 | 3.67 (3.32–4.06) | 3.66 (727.79) | 1.83 (1.67) | 3.57 (3.22) | |
| Spinal pain a | 296 | 5.19 (4.62–5.84) | 5.18 (950.43) | 2.32 (2.12) | 4.98 (4.43) | |
| Fibromyalgia a | 222 | 2.43 (2.12–2.77) | 2.42 (181.36) | 1.26 (1.05) | 2.39 (2.09) | |
| Musculoskeletal discomfort a | 186 | 2.46 (2.12–2.84) | 2.45 (156.77) | 1.28 (1.04) | 2.42 (2.09) | |
| Nervous system disorders | Movement disorder a | 315 | 2.82 (2.52–3.15) | 2.81 (357.80) | 1.47 (1.29) | 2.76 (2.47) |
| Hypokinesia a | 191 | 2.82 (2.44–3.26) | 2.82 (218.30) | 1.47 (1.24) | 2.77 (2.40) | |
| Anosmia a | 135 | 3.41 (2.87–4.05) | 3.41 (222.55) | 1.74 (1.45) | 3.33 (2.81) | |
| Psychiatric disorders | Stress a | 869 | 3.08 (2.88–3.30) | 3.06 (1176.79) | 1.59 (1.48) | 3.00 (2.81) |
| Respiratory, thoracic and mediastinal disorders | Oropharyngeal pain | 1,393 | 3.61 (3.42–3.81) | 3.57 (2499.39) | 1.80 (1.72) | 3.48 (3.30) |
| Rhinorrhoea | 782 | 2.83 (2.63–3.04) | 2.81 (890.59) | 1.47 (1.36) | 2.76 (2.57) | |
| Nasal congestion | 621 | 2.62 (2.42–2.84) | 2.61 (603.20) | 1.36 (1.24) | 2.57 (2.37) | |
| Skin and subcutaneous tissue disorders | Psoriasis | 1,2746 | 31.09 (30.45–31.74) | 26.79 (252731.11) | 4.42 (4.39) | 21.46 (21.02) |
| Pruritus | 4,193 | 2.86 (2.77–2.95) | 2.77 (4715.88) | 1.45 (1.40) | 2.73 (2.64) | |
| Skin exfoliation | 1,270 | 3.14 (2.97–3.33) | 3.11 (1776.38) | 1.61 (1.52) | 3.05 (2.88) | |
| Skin plaque | 960 | 35.76 (33.22–38.49) | 35.38 (23872.01) | 4.73 (4.59) | 26.58 (24.69) | |
| Skin lesion | 716 | 6.92 (6.41–7.46) | 6.87 (3370.28) | 2.70 (2.58) | 6.50 (6.03) | |
| Skin disorder | 568 | 4.41 (4.05–4.79) | 4.38 (1425.38) | 2.09 (1.95) | 4.25 (3.90) | |
| Blister | 565 | 2.56 (2.35–2.78) | 2.55 (519.26) | 1.33 (1.20) | 2.51 (2.31) | |
| Macule | 519 | 53.62 (48.22–59.63) | 53.31 (17547.72) | 5.15 (4.91) | 35.45 (31.88) | |
| Skin fissures | 518 | 7.87 (7.20–8.61) | 7.83 (2871.83) | 2.88 (2.73) | 7.35 (6.72) | |
| Skin haemorrhage | 497 | 9.69 (8.84–10.62) | 9.64 (3521.20) | 3.15 (2.99) | 8.90 (8.12) | |
| Skin discolouration | 473 | 2.32 (2.12–2.54) | 2.31 (345.37) | 1.19 (1.05) | 2.28 (2.08) | |
| Scab | 226 | 4.51 (3.95–5.16) | 4.50 (590.67) | 2.12 (1.90) | 4.36 (3.81) | |
| Pigmentation disorder a | 174 | 7.28 (6.24–8.49) | 7.27 (878.61) | 2.78 (2.50) | 6.85 (5.88) | |
| Skin mass | 132 | 4.35 (3.65–5.17) | 4.34 (325.90) | 2.07 (1.77) | 4.21 (3.53) | |
| Pustular psoriasis | 128 | 11.64 (9.70–13.98) | 11.63 (1117.12) | 3.40 (3.02) | 10.55 (8.78) | |
| Nail disorder a | 110 | 3.45 (2.85–4.17) | 3.45 (184.79) | 1.75 (1.43) | 3.37 (2.78) |
a
Emerging findings of secukinumab associated AEs from FAERS database.
ROR, reporting odds ratio; CI, confidence interval; PRR, proportional reporting ratio; χ2, chi-squared; IC, information component; EBGM, empirical Bayesian geometric mean.