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Demonstrated Efficacy Profile

BICLA Response Rate

Proportion of BICLA Responders

Concomitant Steroid Treatment

SLEDAI-2K Score

SAPHNELO Demonstrated a Superior BICLA Response Rate* (Improvement in All Organ Domains With Moderate or Severe activity at Baseline) at Week 52 vs. Placebo in Tulip 2†‡

Adapted from the SAPHNELO Product Monograph1

BICLA=British Isles Lupus Assessment Group-based Composite Lupus Assessment; CI=confidence interval.

* Patients who discontinued treatment or used restricted medications beyond protocol allowed threshold are considered non-responders.

† TULIP 2 was a 52-week treatment period, Phase 3, multicentre, randomized, double-blind, placebo-controlled study. A total of 362 patients were randomized (1:1) and received anifrolumab 300 mg (n=180) or placebo (n=182) via intravenous infusion every 4 weeks for 52 weeks (13 doses).

‡ The primary endpoint was amended from SRI-4 response to BICLA response at Week 52 following review of the results from the TULIP 1 trial, which failed to achieve a statistically significant treatment benefit using SRI-4 response.

BICLA response at Week 52, was defined as improvement in all organ domains with moderate or severe activity at baseline:

  • Reduction of all baseline BILAG-A to B/C/D and baseline BILAG-B to C/D, and no BILAG worsening in other organ systems, as defined by ≥1 new BILAG-A or ≥2 new BILAG-B;
  • No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of >0 points in SLEDAI-2K;
  • No worsening from baseline in subjects’ lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA VAS;
  • No discontinuation of treatment;
  • No use of restricted medication beyond the protocol-allowed thresholds.

BICLA=British Isles Lupus Assessment Group-based Composite Lupus Assessment; BILAG=British Isles Lupus Assessment Group; PGA=Physician’s Global Assessment; SLEDAI-2K=Systemic Lupus Erythematosus Disease Activity Index 2000; VAS=Visual Analogue Scale.

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Proportion (%) of BICLA Responders Over 52 Weeks in the Tulip 2 Study: SAPHNELO vs. Placebo1*

Adapted from the SAPHNELO Product Monograph1

BICLA=British Isles Lupus Assessment Group-based Composite Lupus Assessment; SE=Standard Error.

* TULIP 2 was a 52-week treatment period, Phase 3, multicentre, randomized, double-blind, placebo-controlled study. A total of 362 patients were randomized (1:1) and received anifrolumab 300 mg (n=180) or placebo (n=182) via intravenous infusion every 4 weeks for 52 weeks (13 doses).

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SAPHNELO Had a Significant Effect on Concomitant Steroid Treatment vs. Placebo in Tulip 2 (Key Secondary Endpoint)*

Of the 47% (n=170) of patients with a baseline OCS use ≥10 mg/day significantly more patients on SAPHNELO reduced their use of OCS at Week 40 and maintained through to Week 52 vs. placebo

Proportion of patients who reduced steroid use to ≤7.5 mg/day at Week 40 and maintained through to Week 52 in TULIP 2: SAPHNELO vs. placebo*

CI=confidence interval; OCS=oral corticosteroid.

* TULIP 2 was a 52-week treatment period, Phase 3, multicentre, randomized, double-blind, placebo-controlled study. A total of 362 patients were randomized (1:1) and received anifrolumab 300 mg (n=180) or placebo (n=182) via intravenous infusion every 4 weeks for 52 weeks (13 doses).

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SLEDAI-2K Score Observed With SAPHNELO and Placebo at Week 208 in a Long-term Extension Study*

The long-term extension study evaluated patients who received SAPHNELO (N=257) or placebo (N=112) in a feeder trial and continued to receive the same treatment.*

Of these patients:

  • 69% of patients on SAPHNELO (177/257)
  • 46% of patients on placebo (52/112) received and completed a total of 4 years on treatment.

At Week 208, the mean SLEDAI-2K score (standard error) was:

  • 3.4 (0.30) in patients who received SAPHNELO (n=140)
  • 4.2 (0.47) in patients who received placebo (n=44)

* Patients who completed TULIP 1 and TULIP 2 (feeder trials) were eligible to continue on treatment in a randomized, double-blind, placebo-controlled, 3-year long-term extension study (LTE). Patients who had received SAPHNELO, either 150 mg or 300 mg, in TULIP 1 and TULIP 2 received SAPHNELO 300 mg in the LTE. Patients who had received placebo in TULIP 1 and TULIP 2 were re-randomized 1:1 to receive either SAPHNELO 300 mg or placebo, giving an approximate SAPHNELO 300 mg: placebo ratio of 4:1 in the LTE.

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