TABLE 2.
Randomized Controlled Clinical Trials of anti-interferon therapy.
| Study | Trial phase | Number of participants | Clinical efficacy (primary endpoints) | Serious adverse events |
|---|---|---|---|---|
| Anifrolumab | ||||
| Furie 2017 (Furie et al., 2017) | 2 | 305 | Patients with anifrolumab had improved SRI and BICLA scores versus placebo | Anifrolumab patients had more infections with Herpes zoster |
| Tanaka 2020 (Tanaka et al., 2020) | 2 | 20 | This study was not powered for clinical efficacy | Adverse events were similar between anifrolumab and placebo |
| Jayne 2022 (Jayne et al., 2022) | 2 | 147 | Similar clinical outcomes for lupus nephritis between anifrolumab and placebo | Increased Herpes Zoster in anifrolumab versus placebo |
| Furie 2019 (Fure et al., 2019) | 3 | 457 | There was no difference in SRI-4 response rates between Placebo and Anifrolumab. However, patients had improved CLASI scores and BICLA responses | There were similar serious adverse events between anifrolumab and placebo |
| Morand 2020 (Morand et al., 2020) | 3 | 362 | Anifrolumab had improved BICLA and SRI scores than placebo | Anifrolumab patients had increased infections with Herpes zoster |
| Sifalimumab | ||||
| Merrill 2011 (Merrill et al., 2011) | 1 | 33 | Less disease flares as measured by SLEDAI | Similar between placebo and Sifalimumab |
| Petri 2012 (Petri et al., 2013) | 1 | 161 | No differences in clinical outcomes between placebo and Sifalimumab | Similar between placebo and Sifalimumab |
| Khamashta 2016 (Khamashta et al., 2016) | 2 | 431 | Patients with Sifalimumab had improved SRI scores than placebo | There was increased Herpes zoster infections with Sifalimumab versus placebo |
| Takeuchi 2020 (Takeuchi et al., 2020) | 2 | 30 | Not powered for clinical efficacy | There was no placebo group, but Sifalimumab was well tolerated |
| Rontalizumab | ||||
| McBride 2012 (McBride et al., 2012) | 1 | 60 | Not powered to detect clinical efficacy between both groups | Similar adverse events between placebo and rontalizumab |
| Kalunian 2016 (Kalunian et al., 2016) | 2 | 238 | No difference between placebo and rontalizumab | Similar adverse events between placebo and rontalizumab |
| IFN-α Kinoid | ||||
| Houssiau 2019 (Houssiau et al., 2020) | 2 | 185 | No differences noted between placebo or IFN-k in the primary endpoints | Similar adverse events between IFN-k and placebo |
Abbreviations: SRI-4, SLE response index-4; BICLA, BILAG-based composite lupus assessment; CLASI, cutaneous lupus erythematosus disease area and severity index; SLEDAI, SLE disease activity index.