Alefacept (CD2 memory T-cell targeting)
Astellas / Biogen (Amevive; withdrawn)
What it is
A memory T-cell targeting fusion protein tested in the T1DAL phase-2 trial. It missed the 12-month primary 2-hour C-peptide endpoint but improved key secondary and 24-month outcomes. The product was withdrawn from the market, so it is mainly a mechanistic lesson, not a practical candidate.
Editorial review: .
Most recent recorded citation date: 2017-07-06. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Delay of onset: Did not meet its 12-month primary endpoint, though secondary and 24-month C-peptide outcomes favored alefacept.[1]
- Important harms and treatment burden
- Safety: The T1DAL reports did not show a major safety imbalance, but the drug is no longer marketed and depleted memory T-cell subsets.[2]
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: At 24 months, over a year after the final dose, C-peptide AUC remained significantly higher and hypoglycemia lower versus placebo.[2]
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 35 × 30 + 55 × 20 + 55 × 20 + 20 × 15 + 5 × 15 = 3625; divide by total weight 100. Unrounded weighted result: 36.25.
Did not meet its 12-month primary endpoint, though secondary and 24-month C-peptide outcomes favored alefacept.[1]
At 24 months, over a year after the final dose, C-peptide AUC remained significantly higher and hypoglycemia lower versus placebo.[2]
The T1DAL reports did not show a major safety imbalance, but the drug is no longer marketed and depleted memory T-cell subsets.[2]
Alefacept was withdrawn from the market, so it is not a practical therapy even if the biology remains informative.[3]
Editor’s take
Alefacept is not coming back as a product, but T1DAL is too informative to omit. It showed that selectively targeting memory T cells could produce a delayed, durable C-peptide signal, while also showing why old discontinued biologics are not the answer by themselves.
The full picture
Why it matters even though it is discontinued
Alefacept targeted CD2-high memory T-cell populations. T1DAL missed its 12-month primary endpoint, but the pattern at 12 and 24 months suggested that selective memory T-cell targeting can preserve beta-cell function and reduce hypoglycemia after diagnosis.12
That makes alefacept a "lesson" record rather than a practical coming therapy: the product is withdrawn, and no T1D approval pathway exists.
Coming soon
ETA · Discontinued product; mechanistic evidence only
Sources
- [1]Targeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study): 12 month results · Peer-reviewed study · 2013-09-23 — PMID 24622414. NCT00965458. Primary 2-hour C-peptide endpoint at 12 months not significant (P=0.065), but 4-hour C-peptide, insulin use and hypoglycemia favored alefacept.
Rigby MR, et al. Targeting of memory T cells with alefacept in new-onset type 1 diabetes (T1DAL study). Lancet Diabetes & Endocrinology (2013).
- [2]Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients · Peer-reviewed study · 2015-07-20 — PMID 26193635. At 24 months, 2-hour and 4-hour C-peptide AUCs were higher; insulin use and major hypoglycemia were lower.
Rigby MR, et al. Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients. Journal of Clinical Investigation (2015).
- [3]Inducing Remission in Type 1 Diabetes With Alefacept · Trial registry · 2017-07-06 — ClinicalTrials.gov NCT00965458; terminated after enrollment 49.