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News - Takeda reports positive topline phase 2/3 results for TAK-881 in primary immunodeficiency disease

Image Credit: Takeda.

May 2026 | Jack Overell, Head of Production, SAE Media Group

Takeda has announced positive topline results from TAK-881-3001, a pivotal Phase 2/3 clinical trial evaluating investigational TAK-881 in patients with Primary Immunodeficiency Disease (PID). The study met its primary endpoint, demonstrating pharmacokinetic (PK) comparability between TAK-881 and HYQVIA, an established immunoglobulin replacement therapy.

TAK-881 is a subcutaneous immunoglobulin (SCIG) 20% therapy facilitated with recombinant human hyaluronidase. Trial results also showed comparable safety, efficacy, and tolerability profiles to HYQVIA, a SCIG 10% therapy facilitated with hyaluronidase. According to Takeda, the findings support TAK-881’s potential to deliver the required immunoglobulin (IG) dose at half the infusion volume of HYQVIA, enabling shorter infusion duration while maintaining flexible dosing every three or four weeks for patients with PID.

Trial Met Primary and Key Secondary Endpoints

The TAK-881-3001 study evaluated pharmacokinetics, efficacy, safety, tolerability, and immunogenicity in adult and pediatric patients aged two years and older with PID who were previously treated with IG therapy. Patients aged 16 years and older were compared directly with HYQVIA.

Topline results showed that TAK-881 achieved comparable PK exposure to HYQVIA, meeting the primary endpoint with a geometric mean ratio of 99.67% (90% CI: 95.10% to 104.46%) for area under the curve over a dosing interval at steady state (AUC0–τ,ss). Secondary endpoints showed comparable infection rates, maintained protective immunoglobulin G (IgG) levels, and a safety profile consistent with HYQVIA, with no new safety signals observed. The safety profile will continue to be assessed in the ongoing extension study.

“These Phase 2/3 results showed the pharmacokinetic profile of TAK-881 was comparable to HYQVIA, an established IG standard of care in patients with PID, while offering the potential advantages of fewer injection sites, a flexible treatment schedule and shorter infusion times,” said Kristina Allikmets, MD, PhD, Senior Vice President and Head of Plasma Derived Therapies R&D at Takeda.

“TAK-881-3001 reflects our broader R&D commitment to advancing next-generation IG therapies and bringing meaningful new treatment options to patients faster, while expanding patient choice and upholding rigorous standards of efficacy and safety.”

Addressing Treatment Burden in PID

For many patients with PID, lifelong immunoglobulin replacement therapy is required to maintain immune protection against infections. Despite clinical effectiveness, current IG therapies can be associated with a significant treatment burden, including frequent or high-volume infusions.

“Patients needing lifelong IG therapy for PID experience a significant burden of care. Improving the administration process can diminish the burden of care by substantively impacting the treatment experience,” said Richard L. Wasserman, MD, PhD, allergist/immunologist and principal investigator for TAK-881-3001.

“These topline results from TAK-881-3001 are encouraging. They show that a highly concentrated, hyaluronidase-facilitated subcutaneous IG can provide immune protection with a more manageable infusion experience intended to enhance the day-to-day lives of patients living with PID.”

Next Steps and Regulatory Plans

Takeda reported that detailed analyses from TAK-881-3001 are ongoing and expects to present additional findings at a future medical forum. The company plans to submit regulatory applications for TAK-881 in the United States, European Union, and Japan during fiscal year 2026.

The ongoing TAK-881-3002 Phase 3 extension study is evaluating long-term safety and tolerability of TAK-881 in patients with PID.

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Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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