REGAIN was a Phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension (OLE). Patients were randomised to receive either SOLIRIS^® (n = 62) or placebo (n = 63) for 26 weeks and allowed to enter the OLE period for up to 4 years.^1,6,10,11

Outcome: 4.2-point improvement in mean MG-ADL total score from baseline to Week 26 among patients receiving SOLIRIS^® vs 2.3-point improvement in patients receiving placebo (P = 0.006).¹ In the study, the average baseline total score for people receiving SOLIRIS^® was 10.5; for people receiving placebo, it was 9.9.^1,6,10,11

REGAIN OLE was the long-term extension trial following the 26th week of REGAIN. Participants received open-label SOLIRIS^® 1200 mg every 2 weeks for up to 4 years after a 4-week blinded induction period. At last OLE assessment, 88.0% (103/117) of participants were using 1 IST vs 98.3% (115/117) at OLE baseline.⁶

LIMITATION: Results and clinical outcomes should be interpreted with caution as the study was designed to evaluate safety and lacked a control group.⁶

^* Reasons for patients stopping/reducing treatment include: symptom improvement, symptom worsening, new indication other than MG for IST use, side effects, and intolerance to existing IST. Others include temporary dosing/treatment changes in response to conditions such as asthma/chronic obstructive pulmonary disease, conjunctivitis, and urinary tract infections or to support surgery.⁶

Additional patient IST dose changes:

• Any given patient may have experienced multiple changes in IST use for a variety of reasons. 71/117 started or increased their dose of ≥ 1 IST, with 44/117 due to symptom worsening⁶

Concomitant ISTs included, but were not limited to: prednisone, prednisolone, methylprednisolone, methylprednisolone sodium succinate, meprednisone, azathioprine and mycophenolate mofetil.⁶

Corticosteroid use was reduced and/or stopped in 47.9% of patients during the REGAIN OLE⁶

Changes in patients’ corticosteroids (prednisone) reduced during REGAIN OLE:⁶

* Corticosteroids used in the OLE were prednisone, prednisolone, methylprednisolone, methylprednisolone sodium succinate, and meprednisone.<sup>6

†</sup> During the OLE, 4 additional patients used prednisone and related corticosteroids (90 patients at OLE baseline).⁶

Reductions in mean daily corticosteroid dose from OLE baseline to last assessment were observed among all patients and those who reduced and/or stopped corticosteroids⁶

At OLE baseline of all patients taking corticosteroids (N = 90):⁶

• Mean daily corticosteroid dose was 16 mg

At last assessment of all patients taking corticosteroids (N = 90):⁶

• Mean daily corticosteroid dose was 12 mg
• Mean daily dose reduced by 16.4% from baseline

ELEVATE was a retrospective observational study using physician-reported EMR data. With physician-reported electronic medical records data, each patient (n = 119) served as their own control. ELEVATE retrospectively observed patient outcomes before SOLIRIS^® initiation for up to 2 years and patient outcomes after SOLIRIS^® initiation for up to 2 years.⁷

LIMITATION: ELEVATE was a retrospective analysis; therefore, results and clinical outcomes should be interpreted with caution.⁷

Observation: Improvement in MG-ADL total scores was observed by 3 months (2.6-point improvement, P < 0.001) and was sustained through 24 months (3.2-point improvement, P < 0.001). Mean MG-ADL total score at baseline was 8.0. A 3.2-point reduction was observed in mean MG-ADL total score from baseline at Week 104 in patients taking SOLIRIS^®.⁷

64% of patients demonstrated reduced prednisone dosage in the ELEVATE analysis⁷

Retrospective chart analysis of prednisone use over 24 months of SOLIRIS^® treatment⁷

• At data cut-off, 82% of all patients in ELEVATE received SOLIRIS^® for ≥ 12 months (n = 98)⁷
• At treatment initiation, 69 patients were receiving prednisone⁷

Percentage of patients with reduced corticosteroids (prednisone) in ELEVATE:⁷

• The percentage of patients who did not change their dosage was 20%, while 3% of patients increased their prednisone dosage (median time: approx. 8 months)⁷
• These results support findings from the REGAIN trial and its open-label extension, and corroborate other real-world studies^6,7

Data were collected from US patients enrolled in a global registry.^14,15 Patients with gMG (n = 110) were treated with SOLIRIS^® for ≥ 1 year and had data on concomitant therapy use from 12 months before SOLIRIS^® initiation to data cut after ~ 3 years.¹⁵ 48.7% of patients were taking corticosteroids, including prednisone, at SOLIRIS^® initiation.⁴

LIMITATION: Observations should be interpreted with caution as this was a retrospective observational review from a registry.^14,15

Observation: The mean MG-ADL total score decreased 4.3 points (from 8.3 before SOLIRIS^® treatment to 4.0 at or after registry enrolment).¹⁵

More patients with gMG were able to treat with ≤ 5 mg of prednisone compared to baseline in a global gMG registry¹⁴

Observations after 1 year of treatment with SOLIRIS^®

At treatment initiation, the number of patients treated with a prednisone dose ≥ 10 mg/day was 31 (47%).¹⁴

Prednisone dosages reduced after 1 year of treatment in the registry:¹⁴

The objective of this analysis was to assess changes in concomitant therapies after initiation of SOLIRIS^® in patients with gMG. Reasons for concomitant therapy discontinuation were not assessed.¹⁴

There were observed reductions in corticosteroid (prednisone) use to < 10 and < 5 mg per day with the use of SOLIRIS^®.¹⁴

To reduce the risk of infection, all patients must be vaccinated against meningococcal infections at least 2 weeks prior to initiating SOLIRIS^® unless the risk of delaying SOLIRIS^® therapy outweighs the risk of developing a meningococcal infection. Patients who initiate SOLIRIS^® treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Patients must receive vaccination according to current national vaccination guidelines for vaccination use.¹

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