Clinical trials and drug discovery
Table 3 Most frequently reported AEs (≥5% frequency in either group) in IS-inexperienced or IS-experienced patients following treatment with anifrolumab or placebo in addition to standard therapy IS-inexperienced IS-experienced Anifrolumab 300mg (n=127) Placebo (n=130) Total (n=257) Anifrolumab 300mg (n=233) Placebo (n=236) Total (n=469) Infections and infestations 85 (66.9) 70 (53.8) 155 (60.3) 173 (74.2) 142 (60.2) 315 (67.2) Nasopharyngitis 24 (18.9) 12 (9.2) 36 (14.0) 40 (17.2) 30 (12.7) 70 (14.9) Upper respiratory tract infection 20 (15.7) 11 (8.5) 31 (12.1) 41 (17.6) 25 (10.6) 66 (14.1) Bronchitis 11 (8.7) 9 (6.9) 20 (7.8) 27 (11.6) 8 (3.4) 35 (7.5) Sinusitis 10 (7.9) 6 (4.6) 16 (6.2) 10 (4.3) 16 (6.8) 26 (5.5) Urinary tract infection 9 (7.1) 15 (11.5) 24 (9.3) 33 (14.2) 37 (15.7) 70 (14.9) Pharyngitis 6 (4.7) 7 (5.4) 13 (5.1) 8 (3.4) 9 (3.8) 17 (3.6) Oral herpes 3 (2.4) 3 (2.3) 6 (2.3) 12 (5.2) 7 (3.0) 19 (4.1) Herpes zoster 2 (1.6) 1 (0.8) 3 (1.2) 21 (9.0) 4 (1.7) 25 (5.3) Infusion-related reaction 12 (9.4) 7 (5.4) 19 (7.4) 29 (12.4) 20 (8.5) 49 (10.4) Cough 12 (9.4) 4 (3.1) 16 (6.2) 9 (3.9) 9 (3.8) 18 (3.8) Headache 9 (7.1) 9 (6.9) 18 (7.0) 17 (7.3) 23 (9.7) 40 (8.5) Back pain 8 (6.3) 8 (6.2) 16 (6.2) 13 (5.6) 8 (3.4) 21 (4.5) Nausea 7 (5.5) 4 (3.1) 11 (4.3) 9 (3.9) 18 (7.6) 27 (5.8) Arthralgia 6 (4.7) 4 (3.1) 10 (3.9) 14 (6.0) 5 (2.1) 19 (4.1) Vomiting 6 (4.7) 0 6 (2.3) 12 (5.2) 10 (4.2) 22 (4.7) Diarrhoea 3 (2.4) 6 (4.6) 9 (3.5) 8 (3.4) 15 (6.4) 23 (4.9) Insomnia 2 (1.6) 8 (6.2) 10 (3.9) 4 (1.7) 8 (3.4) 12 (2.6)
AE, adverse event; IS, immunosuppressant.
assessments were evaluated longitudinally over 52 weeks, allowing examination of not only the timing of onset of treatment effects but also the maintenance of any effects over time. In addition, pooling data from the TULIP-1/TULIP-2 trials provided a large sample size for analysis. Limitations include the post hoc nature of this study, and the possibility that patients with no reported IS use had previously received IS treatment. In addition, as the trial entry criteria limited enrolment of patients to those with moderate-to-severe disease who were 18–70 years of age, these findings may not be generalisable to all patients with SLE. In summary, this post hoc subgroup analysis of pooled TULIP-1/TULIP-2 data supports previous evidence that anifrolumab is an effective and well-tolerated treatment for patients with moderate-to-severe SLE. This study also demonstrates the consistent benefit of treatment with anifrolumab alongside other standard therapies and provides support for its use in combi- nation with other standard therapies, regardless of IS treatment history. Though additional studies are needed, these findings support the use of anifrolumab in combination with IS for patients with more severe, non-renal manifestations of SLE and, importantly, for treatment of this chronic and progressive disease, without IS or previous failure of IS in patients with less severe manifestations of SLE.
patients. Treatment-related AEs, any AESI and herpes zoster rates were lower in IS-inexperienced patients versus IS-experienced patients receiving anifrolumab. IS-experienced patients generally had more AESI, which is supported by the known association of IS with AEs (eg, herpes zoster). 19 Specifically, IS-inexperienced patients treated with anifrolumab experienced lower rates of infec- tions and infestations (66.9% vs 74.2%) and herpes zoster (1.6% vs 9.0%) compared with IS-experienced patients. Although exploratory studies do not provide defin- itive evidence regarding the optimal sequencing of biologic therapy, the real-world, Komodo Health retro- spective cohort study reported lower SLE flare rates, reduced GC use and longer median time to new organ damage in patients who initiated belimumab before IS compared with those who initiated belimumab after IS. 20 21 Together with the results of the current study, which support anifrolumab efficacy regardless of prior IS use and improved safety in patients without prior IS treatment, such results are encouraging and may help inform future research on the sequencing of biologic therapies. Strengths of this post hoc analysis of pooled TULIP-1/TULIP-2 trial data include the number of efficacy assessments to broadly evaluate the effect of anifrolumab versus placebo in patients with moderate- to-severe SLE based on reported IS use. Efficacy
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Doria A, et al . Lupus Science & Medicine 2026; 13 :e001891. doi:10.1136/lupus-2025-001891
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